#Non-alcoholic Steatohepatitis Therapeutics Market

[adimmr]

#Non-alcoholic Steatohepatitis Therapeutics Market

[brianwhary]

In-Depth Analysis of Non-Alcoholic Steatohepatitis Clinical Trials

Non-Alcoholic Steatohepatitis (NASH) represents a burgeoning public health concern, underscored by its escalating prevalence and significant disease burden. Clinical trials serve as pivotal platforms for elucidating the pathophysiology of NASH and evaluating novel therapeutic modalities. Our comprehensive analysis delves into the intricate landscape of NASH clinical trials, offering invaluable insights for researchers, clinicians, and stakeholders.

Current Landscape of NASH Clinical Trials

NASH clinical trials encapsulate a diverse array of investigational approaches, ranging from lifestyle interventions to pharmacological agents targeting various facets of NASH pathogenesis. The multifaceted nature of NASH necessitates a multifaceted approach in trial design and therapeutic intervention.

Key Trends and Developments

Pharmacological Interventions

Pharmacological interventions constitute a cornerstone in NASH clinical trials, with numerous agents targeting different pathophysiological pathways. From insulin sensitizers and lipid-lowering agents to anti-inflammatory and antifibrotic therapies, the armamentarium against NASH continues to expand.

For more regional insights into the NASH clinical trials market, download a free report sample

Lifestyle Modifications

Lifestyle modifications, encompassing dietary interventions, exercise regimens, and weight management strategies, are integral components of NASH clinical trials. Lifestyle interventions aim to ameliorate metabolic abnormalities and mitigate disease progression, often complementing pharmacological therapies.

Biomarker Development

The quest for reliable biomarkers for NASH diagnosis, prognostication, and therapeutic response assessment remains a paramount objective in clinical research. Biomarker development initiatives seek to identify non-invasive, surrogate markers reflective of NASH activity and severity, thereby facilitating clinical trial endpoints and patient stratification.

Challenges and Opportunities

Disease Heterogeneity

The heterogeneous nature of NASH poses a formidable challenge in clinical trial design and patient selection. Efforts to characterize distinct NASH phenotypes and identify biomarkers predictive of treatment response are essential for optimizing trial outcomes and therapeutic efficacy.

Endpoint Selection

Selecting appropriate clinical endpoints that accurately reflect NASH disease activity and progression remains a contentious issue in clinical trial design. Consensus regarding validated surrogate endpoints and clinically meaningful outcomes is imperative for advancing therapeutic development in NASH.

Regulatory Landscape

Navigating the evolving regulatory landscape surrounding NASH drug development presents inherent complexities and uncertainties. Close collaboration between regulatory agencies, industry stakeholders, and academic researchers is indispensable for streamlining trial protocols and expediting drug approval processes.

Future Directions

Personalized Medicine

The paradigm shift towards personalized medicine heralds a new era in NASH therapeutics, wherein treatment decisions are tailored to individual patient characteristics and disease phenotypes. Biomarker-driven approaches and genomic profiling hold promise in optimizing treatment selection and predicting therapeutic responses.

Combination Therapies

The synergistic effects observed with combination therapies underscore the potential for enhanced therapeutic efficacy in NASH management. Rational drug combinations targeting complementary pathophysiological pathways offer a promising avenue for mitigating disease progression and improving clinical outcomes.

Patient-Centric Trials

Adopting a patient-centric approach in clinical trial design and implementation is paramount for enhancing patient engagement, retention, and satisfaction. Incorporating patient-reported outcomes and integrating patient preferences into trial protocols can enhance the relevance and success of NASH clinical trials.

Conclusion

In conclusion, our comprehensive review delineates the dynamic landscape of NASH clinical trials, highlighting key trends, challenges, and future directions. By fostering collaborative research endeavors and embracing innovative approaches, we endeavor to accelerate therapeutic innovation and alleviate the burden of NASH on a global scale.

#Non Alcoholic Steatohepatitis Clinical Trials Analysis

[prismmediawire]

PRISM MarketView Spotlights Companies Leading the Charge in Liver Disease Treatment Following Landmark FDA Approval

New York, N.Y., March 18, 2024 - PRISM MarketView, a leading provider of unbiased market insight and company news, today highlights the FDA’s landmark approval of Rezdiffra™ and the companies leading the charge in developing new, safe, and effective treatments for liver disease.

The landmark decision has shone a light on metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic fatty liver disease, a leading cause of liver-related mortality that affects between six and eight million adults in the US. The number of MASH cases is expected to skyrocket to an estimated 27 million cases in the US by 2030, according to the Global Liver Institute.

In 2023, liver disease received a much-needed rebrand, removing the words ‘fatty’ and ‘alcohol’ from the names, which has left patients feeling stigmatized and their illness trivialized. Experts believe this overhaul may be the rebrand that liver disease needs to generate better clinical results for specific patient populations. PRISM MarketView takes a closer look at five of our top picks for delivering the next potential treatments for the liver disease patient population, including Inventiva (Nasdaq: IVA), NeuroBo Pharmaceuticals (Nasdaq: $NRBO), and Better Therapeutics (Nasdaq: BTTX). The full article can be found at:

About PRISM MarketView:

Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on Twitter.

PRISM MarketView does not provide investment advice.

Disclaimer:

This communication was produced by PRISM MarketView, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its clients’ securities. See www.pcgadvisory.com/disclosures

Media Contact Company Name: Prism MarketView Email: [email protected] Phone: [phone]

#press release #prism mediawire #stock market #investing #prismdigitalmedia #prismmarketview #healthcare #nasdaq #biotech #pharmaceutical #biotech and pharmaceuticals #stock index #stocks to watch

[nidarsanafwr]

Non-Alcoholic Steatohepatitis (Nash) Therapeutics And Diagnostics Market Analysis, Share, Size and Forecast 2031

#NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarket #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketSize #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketShare #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketScope

[furrywerewolfdreamland]

#market #industry #analysis #report

[smitadeshmukh123]

Rising Occurrence of NAFLD Cases and their Transformation to NASH to Boost Nonalcoholic Steatohepatitis Market

According to a new market report published by Transparency Market Research “Nonalcoholic Steatohepatitis Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 - 2025”, the nonalcoholic steatohepatitis (NASH) therapeutics market is anticipated to expand at a CAGR of 10.7% from 2015 to 2025 to reach US$20.27 bn by 2025.

Nonalcoholic Steatohepatitis (NASH) is a syndrome that advances in patients who are not alcoholic; it causes liver damage that is histologically indistinguishable from alcoholic hepatitis. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware of their liver problem. However, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and no longer able to work properly. It develops most frequently in patients with at least one of the following risk factors as obesity, dyslipidemia, and glucose intolerance. Pathogenesis is not clearly understood but seems to be linked to insulin resistance. Most of the patients are asymptomatic. Laboratory outcomes include elevations in aminotransferase levels. Biopsy is essential to confirm the diagnosis. Treatment mainly focusses on elimination of causes and risk factors.

Read Full Report: http://www.transparencymarketresearch.com/nonalcoholic-steatohepatitis-market.html

The prevalence of NASH and NAFLD is increasing across the globe but it is more in developed regions such as North America. Both NASH and NAFLD are becoming more common, perhaps because of the greater number of Americans with obesity. In the past few years, the rate of obesity has almost doubled in adults and tripled in children. Obesity also adds to diabetes and high blood cholesterol, which can further complicate the health of people suffering from NASH. Diabetes and high blood cholesterol are also becoming more common among Americans.

Currently, no specific therapies exist for NASH treatment. The most important recommendations given to persons with this disease are weight reduction (if overweight), following a balanced and healthy diet, increasing physical activity, avoiding alcohol and avoiding unnecessary medications.

The NASH market is segmented based on drug type which includes potential phase III candidates such as Obeticholic acid (OCA), Aramchol, Saroglitazar and Elafibranor. Moreover, the report enlists the candidates in Phase I and Phase II clinical trials. Based on the drug type, Elafibranor is expected to account for a major share of this market and the market for Elafibranor is expected to grow at the highest CAGR. This growth is majorly due to Elafibranor which is considered to be the most advanced drug in this category.

Download exclusive Sample of this report: http://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=7691

Major players in this market are Astazeneca Plc (U.K.), Intercept Pharmaceuticals Inc. (U.S.), Galmed Pharmaceuticals Ltd. (Israel), GENFIT SA (France), Gilead Sciences, Inc. (U.S.), Zydus Cadila (India), Immuron Ltd. (Australia), Conatus Pharmaceuticals (U.S.), and Tobira Therapeutics, Inc. (U.S.).

#Non-alcoholic Steatohepatitis Therapeutics Market

[kritikarehani]

Increasing incidence is fuelling the Hepatocellular Carcinoma Market

The most common form of primary liver cancer, Hepatocellular Carcinoma (HCC) is a malignant tumour of hepatocytes.

Increasing Hepatocellular Carcinoma (HCC) Incidence

Hepatocellular Carcinoma incidence is growing worldwide because of the dissemination of Hepatitis B and C virus infection making it the fifth most common cause of cancer.

 Hepatocellular cell carcinoma is found to be more common in males as compared to females. 

Moreover, 70%–90% of HCC patients have a previous history of chronic liver disease and cirrhosis.

This indicates their chances of being diagnosed with chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), alcoholic liver disease, and non-alcoholic steatohepatitis (NASH).

According to DelveInsight, a healthcare business consulting firm, the total HCC incident cases in G8 countries estimated to be around 4,58,170 in 2016.  

On the other hand, the total Diagnosed Advanced Hepatocellular Carcinoma cases in G8 countries around 1, 60,565 cases and the numbers are expected to increase in the coming years.

Moreover, DelveInsight estimates that the total HCC patients in G8 countries on first- and second-line therapies were 39,224 and 14,215, respectively.

Increasing Hepatocellular Carcinoma therapy market 

Opdivo developed by Bristol-Myers Squibb is approved only in the US and Stivarga, again a Bayer’s therapy got FDA recommendation in 2017 itself. Both of the treatments have created a positive impact on the Hepatocellular Carcinoma market size.

Other Hepatocellular Carcinoma therapies include Miripla [Miriplatin, Dainippon Sumitomo Pharma], and Lenvima which got approved only in Japan. 

Booming Hepatocellular Carcinoma market 

Hepatocellular Carcinoma Market analysis demonstrates that the HCC Market size was about USD 723.4 million in 2016 in G8 countries.

DelveInsight estimates that the United States had the highest Hepatocellular Carcinoma market share in 2016, as compared to EU5 (Germany, France, Italy, Spain & UK) Japan and China. Among EU5, Italy has the highest Hepatocellular market, while the UK had the lowest HCC market.

At present, the Hepatocellular Carcinoma therapeutic market size is mainly accounted for by the protein Kinase inhibitor, i.e., Nexavar (Sorafenib), a product of Bayer.

Hepatocellular Carcinoma Emerging Drugs Analysis

The dynamics of Hepatocellular Carcinoma market is anticipated to change in the coming years owing to the expected launch of therapies.

There are presently three emerging therapies focused on the treatment of HCC- Ramucirumab (Eli Lilly; 2nd Line of Therapy), Cabozantinib (Exelixis; 2nd Line of Therapy), and Lenvima (Eisai Pharmaceuticals & Merck; 1st Line of therapy).

#hepatocellular carcinoma #cancer #hepatocellular carcinoma market #liver disease #healthcare #health

[marketresearchsblog]

Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market: Insights & Forecast with Potential Impact of COVID-19 (2022-2031)

The global non-alcoholic steatohepatitis (NASH) drugs market is expected to reach US$84.34 billion in 2029, growing at a CAGR of 39.13%, for the duration spanning 2022-2031. The factors such as rising healthcare expenditure, increasing pharmaceutical R&D expenditure, surging diabetic population, escalating obese population, unmet medical needs and sedentary lifestyles are expected to drive the growth of the market. However, the market growth would be challenged by lethargic drug approval process, high treatment cost and less definitive diagnostic methods for NASH/NAFLD. A few notable trends include surging market penetration for NASH major drugs, increasing prevalence of NASH, progressing NASH diagnosis methods and biomarkers, NASH pipeline drugs under development and growth in e-commerce pharmaceutical products sales. The global non-alcoholic steatohepatitis (NASH) drugs market has two major segments, based on drug classes - Off-Label drugs and Therapeutic Drugs. The current NASH drugs market is wholly occupied by off-label drugs as there are no clinically approved medicines for the treatment of NASH. However, certain therapeutic drugs, from large pharmaceutical drugs, are expected to enter the market in coming years, with considerable market share. The need for definitive NASH treatment would lead to strong market penetration of the therapeutic drugs during the forecasted period.

Access Free PDF With Graphs and Charts : https://www.sdki.jp/sample-request-62268 The fastest growing regional market would be the U.S., due to the increasing prevalence of NASH, along with forthcoming launches of various NASH therapeutic drugs. Moreover, Europe is also expected to hold a significant share in the global NASH therapeutics market, owing to the growing awareness amongst the inhabitants, regarding NASH diagnosis and treatment methods. Scope of the report: The report provides a comprehensive analysis of the global Non-Alcoholic Steatohepatitis (NASH) Drugs market, segmented into Off Label Drugs and Therapeutic Drugs sub markets. The major regional markets (the U.S., Europe and Rest of World) have been analyzed. The market dynamics such as growth drivers, market trends and challenges are analyzed in-depth. The competitive landscape of the market, along with the company profiles of leading players (Bristol Myers Squibb, Gilead Sciences, Allergan Plc. (Tobira), Intercept Pharmaceuticals, Galmed Pharmaceuticals and Genfit SA) are also presented in detail. Request Sample For More Insights : https://www.sdki.jp/sample-request-62268 Key Target Audience: NAFLD/NASH Drugs Manufacturers Chemical Suppliers End Users (Hospital, Medical centers, Clinical Institutes) Healthcare Consulting Firms Investment Banks Government Bodies & Regulating Authorities

[industry365]

Human Microbiome Therapeutics Market Is Expected To Reach New Growth Revenues During 2021-2028

The global human microbiome therapeutics market size is expected to reach USD 1,544.6 million by 2027 according to a new study by Polaris Market Research. The report “Human Microbiome Therapeutics Market Share, Size, Trends, Industry Analysis Report, By Product (Probiotics, Prebiotics, Medical Foods, and Prescription Drugs); By Therapeutic Area (Autoimmune Disorders, Dental Disorders, Digestive and Gastrointestinal Disorders, Dermatological Disorders, Infectious Disease, Metabolic Disorders, Oncology, and Others); By Indication (Acne Vulgaris, Atopic Dermatitis, Clostridium difficile Infection, Colorectal Cancer, Diabetes, Inflammatory Bowel Disease (IBD), Lactose Intolerance, Lung Cancer, Non-alcoholic steatohepatitis (NASH), Obesity, and Coeliac Disease); By Approach (Small Molecule Therapies, Single Strain Whole Bacteria, Microbial Consortia, Genetically Modified Single Strain Bacteria, Phage Cocktail, and Microbial Ecosystems), By Regions; Segment Forecast, 2020 –2027” gives a detailed insight into current market dynamics and provides analysis on future market growth.

Microbiome refers to the residing micro-organisms genomes in the human body, particularly in the gut. The human body comprises more than 100 trillion microbes and around 2 million microbe genomes. These microbiota plays a significant role in the body’s physiological functions and includes viruses, bacteria, and fungi. Primarily it has Bacteroidetes (gram negative) and Firmicutes, commonly Clostridium and Lactobacillus sp. (gram positive). The majority of these are strict anaerobes, with fungi and archaebacteria comprising less than 1 per cent of the total population.

Download sample: https://www.polarismarketresearch.com/industry-analysis/human-microbiome-therapeutics-market/request-for-sample

The global market is driven by an increased focus on microbiome based early diagnosis of diseases, increase in the prevalence of diseases due to dysbiosis, rising collaborations, and strongly funded government backed microbiome research projects. In November 2019, the Million Microbiome of Humans Project (MMHP) was launched in collaboration with France, Denmark, China, Latvia, Sweden and other countries to co-operate in meta-genomic research. The aim is to create the largest human microbiome database from analyzing more than one million samples gathered from reproductive tract, gut, skin, and other organs in the next few years.

Market participants such as Enterome Bioscience, Biotagenics, Seres Therapeutics, Oxidien Pharmaceuticals, LLC, BoobyBiome, 4D Pharma PLC, UBiome, Carbiotix, E.I. du Pont de Nemours and Company, Finch Therapeutics, GNUbiotics Sciences, ClearB Therapeutics, GoodBelly, GoodGut, Synlogic, Second Genome, 16S Technologies, 5QBD-Biotech, Vedanta Biosciences, Holobiome, Commense, Ferring Pharmaceuticals, Evelo Biosciences, CoreBiome, Igen Biolab Group, ViThera Pharmaceuticals, DermBiont, Hyggut, Embion Technologies, Lactobio, BiomX, Exeliom Biosciences, and LNC Therapeutics are some of the key players operating in the concerned market.

VID-19 is open, and dosing to start very soon. The company is world leader in the production of live bio-therapeutics (live microbiome used to cure disease). Its products are the orally delivered single strain bacteria, which are naturally present in the human gut.

Get Discount offer: https://www.polarismarketresearch.com/industry-analysis/human-microbiome-therapeutics-market/request-for-discount-pricing

Polaris Market research has segmented the Human Microbiome Therapeutics market report on the basis of product, therapeutic area, indication, approach, and region

Human Microbiome Therapeutics Product Outlook (Revenue – USD Million, 2016 – 2027)

Probiotics

Prebiotics

Medical Foods

Prescription Drugs

Human Microbiome Therapeutic Area Outlook (Revenue – USD Million, 2016 – 2027)

Autoimmune Disorders

Dental Disorders

Digestive and Gastrointestinal Disorders

Dermatological Disorders

Infectious Disease

Metabolic Disorders

Oncology

Others

Human Microbiome Therapeutics Indication Outlook (Revenue – USD Million, 2016 – 2027)

Acne Vulgaris

Atopic Dermatitis

Clostridium Difficile Infection

Colorectal Cancer

Diabetes

Inflammatory Bowel Disease (IBD)

Lactose Intolerance

Lung Cancer

Non-alcoholic steatohepatitis (NASH)

Obesity

Coeliac Disease

Human Microbiome Therapeutics Approach Outlook (Revenue – USD Million, 2016 – 2027)

Small Molecule Therapies

Single Strain Whole Bacteria

Microbial Consortia

Genetically Modified Single Strain Bacteria

Phage Cocktail

Microbial Ecosystems

Human Microbiome Therapeutics Regional Outlook (Revenue – USD Million, 2016 – 2027)

North America

Europe

Asia Pacific

Central & South America

Middle East & Africa

U.S.

Canada

France

Germany

UK

Italy

Netherlands

Spain

Austria

China

India

Japan

Malaysia

Australia

South Korea

Mexico

Brazil

Argentina

UAE

Saudi Arabia

Israel

South Africa

Buy Now: https://www.polarismarketresearch.com/checkouts/6541

[severetacoartisan]

[nidarsanafwr]

https://rollbol.com/blogs/1755233/Non-Alcoholic-Steatohepatitis-Nash-Therapeutics-And-Diagnostics-Market-Analysis-Share

Non-Alcoholic Steatohepatitis (Nash) Therapeutics And Diagnostics Market Analysis, Share, Size and Forecast 2031

#NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarket #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketSize #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketShare #NonAlcoholicSteatohepatitisTherapeuticsAndDiagnosticsMarketScope

[candyswift-ny]

The Incidence of Liver Cancer Caused by NAFLD is Rising Rapidly

According to statistics, the global prevalence of non-alcoholic fatty liver disease (NAFLD) is about 25%, ranging from 13% in Africa to 42% in Southeast Asia. Studies also predict that from 2016 to 2030, the prevalence of NAFLD in France, Germany, Italy, China, Japan, Spain, the United Kingdom and the United States will increase to 56%.

This disease can cause a type of fat called triglycerides to gather in the liver, which can lead to damage. NAFLD can cause cirrhosis and liver failure. It commonly occurs in people who are overweight or obese, or who have type 2 diabetes or a metabolic syndrome characterized by high blood sugar, extra body fat around the waist, and abnormal cholesterol levels. NAFLD includes a series of diseases, such as fatty liver, simple steatosis, and non-alcoholic steatohepatitis (NASH). And what should be noticed is that NAFLD and liver cancer do have some correlations.

Primary liver cancer has several well-recognized risk factors, such as HBV (hepatitis B) and HCV (hepatitis C) infection, alcohol abuse and aflatoxin. And studies also showed that NAFLD, affecting a large proportion of the US population, is associated with an increased risk of liver cancer, mainly hepatocellular carcinoma (HCC), which is now the leading cause of obesity-related cancer deaths in middle-aged men in the USA.

The previous study has found that palmitic acid (PA) treatment accelerated the production of exosomes in hepatocytes and altered their miRNA profile. In addition, exosomes originating from PA-treated hepatocytes induced the increased expression of fibrotic genes in hepatic stellate cells (HSCs). Therefore, exosomes may have important roles in the crosstalk between hepatocytes and HSCs during the progression from simple steatosis to NASH, thus increase the risk of liver cancer.

The global incidence of NAFLD-related liver cancer ranges from 1% to 38%. Among them, countries with higher incidence tend to have higher obesity rates. Data show that from 1990 to 2015, the incidence of liver cancer has increased by 75%.

In daily life, patients with NAFLD should take actions to prevent liver cancer, such as weight loss, smoking cessation, and alcohol quitting. Studies have shown that weight loss of 10% or more can improve NAFLD in 90% of patients, and reduce liver fibrosis in 45% of patients. For the prevention of liver cancer, bariatric surgery is not currently recommended; the anti-inflammatory, anti-angiogenesis and liver fibrosis effects of aspirin and statins have been basically recognized in academia, but further research is still needed to prove their efficacy and safety. In short, metabolic disorders such as obesity and diabetes are gradually increasing, and people must take precautions before they happen. Preventing NAFLD is a way to block the occurrence of liver cancer from the source.

Based on a deep scientific understanding of NASH and rich experience in the discovery & development of various drugs, Creative Biolabs has the ability to offer one-stop customizable NASH drug development services, from the development of diagnostic biomarkers, the discovery of potential therapeutic targets to the provision of preclinical models, to help researchers bring new therapies to the market.

[your-dietician]

Signs Agreement with Vetbiolix for Development of Piclidenoson for Pets

New Post has been published on https://depression-md.com/signs-agreement-with-vetbiolix-for-development-of-piclidenoson-for-pets/

Signs Agreement with Vetbiolix for Development of Piclidenoson for Pets

All pre-clinical, clinical, and regulatory development work to be conducted and financially covered by Vetbiolix

Veterinary market has potential for a shorter path to regulatory approval and product revenues

PETACH TIKVA, Israel, June 28, 2021–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has signed a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats.

Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use.

The canine osteoarthritis market is projected to reach $3 billion by 2024. According to Grand View Research, the broader global companion animal health market is estimated at a value of $20 billion in 2021 and is expected to grow to $27 billion by 2028.

Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects, and an injectable disease modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. Piclidenoson, an oral drug that has a favorable safety profile in humans and in animal studies, offers a potentially safe and effective oral treatment for canine osteoarthritis.

“The veterinary market is a significant opportunity where our drugs may have an impact. Both the size of the market and the shorter timelines to regulatory approval have the potential to result in milestone and royalty revenues for Can-Fite. We believe Piclidenoson’s safety and efficacy data in over 1,000 humans, as well as preclinical data from small animals, indicate it may offer relief to the growing number of companion animals with osteoarthritis,” stated Can-Fite VP of Business Development, Dr. Sari Fishman.

Story continues

Matthieu Roquette, President at Vetbiolix commented, “The quality of preclinical and clinical data generated by Can-Fite on Piclidenoson and its pharmacological profile make this highly selective A3 Adenosine Receptor Agonist a drug candidate likely to meet the unmet veterinary medical need to date in the management of osteoarthritis pathology in dogs and cats. Moreover, the mechanism of action of Piclidenoson makes this product a strong candidate for a large spectrum of inflammatory disease indications affecting Pets. We are aiming to enter in veterinary regulatory development by the end of 2022 based on clinical proof of concept data we will generate within the next 12 months.”

In 2019, the U.S. Patent and Trademark Office issued to the Can-Fite patent #10,265,337 titled “Use of A3 Adenosine Receptor Agonist in Osteoarthritis Treatment” for Piclidenoson in the treatment of osteoarthritis in mammals.

About Vetbiolix

Vetbiolix develops innovative products for treatment and prevention of diseases affecting pets. As pharmaceutical and biotech companies research novel molecules and compounds for human medicine, tests in different species often reveal exciting possibilities for pets. Vetbiolix has developed a unique approach focused on turning this potential into innovative prescription medicines and care products for pets. To date, veterinarians have still few therapeutics and real preventive care products at their disposal that have been specifically developed and approved for pets. Along with a virtual VetBiotech organization, Vetbiolix exclusively focuses on clinical developments of prescription medicines, diagnostics, nutraceuticals and care products for pets, thanks to its qualified external R&D partners in Europe & the US. Vetbiolix is supported by the Eurasanté Bio-Incubator, the northern France health cluster ranked among the top 20 best European incubators fostering pharm/biotech start-up development (Labiotech.eu 2019).

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210628005218/en/

Contacts

Can-Fite BioPharma Motti Farbstein [email protected] [phone]

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