Calgary, Alberta–(Newsfile Corp. – November 23, 2021) – Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company“ or “Marvel“), today announced that it has found its lead asset, MB-204 was active in two different pre-clinical models of non-alcoholic steatohepatitis (“NASH”) using fibrosis and the non-alcoholic fatty liver disease activity score (NAS score) endpoints that are analogous to the known approvable NASH endpoints with the FDA. These early indications highlight a promising trajectory for MB-204 as a prospective treatment for NASH disease.
NASH is a global disease that affects a significant portion of the population with a global market representing over $20B USD. The major concern for physicians and their patients is the development of liver fibrosis which can result in cirrhosis and liver cancer. Currently, there are no approved treatments for NASH, and very few treatments in development are focused on reduction in fibrosis. The most advanced active candidate specifically targeting fibrosis is Cenicriviroc which is currently in Phase 3 clinical trials.
The Company studied its lead adenosine A2a receptor antagonist MB-204 in two pre-clinical NASH models and concluded the following:
- In the first model, focusing on the NAS Score, 6-week old STAM® mice (SMC, Japan) were treated with MB-204 (10 mg/kg), once daily per oral for 3 weeks. A 1.4 point drop in the NAS score (p<0.01) was observed, with a particularly strong effect seen on hepatocyte ballooning (p<0.0001) compared to vehicle.
- In the second model, focusing on fibrosis, 30-week old pre-aged NASH mice (Taconic) were treated once daily per oral for approximately 3 weeks with MB-204 (10mg/kg) or Cenicriviroc (30 mg/kg), the leading anti-fibrotic treatment for NASH in Phase 3 clinical trials. A 47% reduction in fibrosis was observed comparing control and MB-204, and MB-204 was significantly better (p<0.05) compared to Cenicriviroc in this experiment.
Bruce N. Cronstein, MD and Marvel Scientific Advisory Board advisor stated, “This is encouraging for the NASH treatment space and is not surprising as our laboratory was the first group to link the adenosine A2a receptor to liver fibrosis over 20 years ago. Current thinking is that A2a antagonism, at least in part, likely prevents activation of hepatic stellate cells, the cells that produce collagen and fibrosis in the liver. Fibrosis is a central concern for physicians when a patient presents with NASH as it is highly associated with the development of liver dysfunction, cirrhosis, cancer and death.”
“We are pleased with these further MB-204 results as we believe it could represent a first-in-class treatment for the disease and further de-risks our asset by having a second, non-neurological disease we can pursue,” said Dr. Mark Williams, President and Chief Science Officer. “Early indications show promising signs for the future of our lead candidate, with next steps including continuing additional pre-clinical trial and ultimately moving towards a Phase 1 study. We are extremely excited about the opportunity that exists with MB-204 and believe this could become a viable and standard treatment for NASH disease in the future.”
MB-204, is a fluorinated derivative developed by Marvel of the US-FDA approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world, whose consumption has been associated with a reduced risk for developing Parkinson’s disease, Alzheimer’s disease and improving concentration.
About Professor Bruce N. Cronstein, MD
Professor Bruce N. Cronstein, MD, is a Professor at the NYU Grossman School of Medicine (for the Departments of Medicine, Pharmacology, and Pathology). Prof. Cronstein is considered the world expert on adenosine, and has led adenosine research for over 38 years, publishing a monumental 365 peer-reviewed articles. The Cronstein laboratory has explored the role of adenosine across multiple thematic areas (including studying its application in neutrophils, inflammation, methotrexate treatments, and since the early 2000s, the adenosine A2A receptor). Prof. Cronstein has led the research of A2A receptor functions, including its roles in dermal fibrosis and scarring, hepatic fibrosis and fatty liver, bone healing, and more recently, chondrocyte metabolism and cartilage matrix maintenance. Prof. Cronstein’s discoveries have led to novel therapeutics and treatments now considered best practice.
About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company that utilizes a “drug redevelopment” approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought as the new potential asset is developed by the Company. The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.
Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer’s, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis (“NASH”). Marvel is also exploring additional undisclosed targets to expand its asset pipeline.
Virtus Advisory Group
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
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