Source: Marvel Biosciences.
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  • Marvel (MRVL) has initiated its 7-day dose-ranging toxicology study for its lead molecule MB-204
  • A vital step in preparation to initiate FDA Phase I human clinical trials, this animal trial tests the safety of new drugs before being able to run trials on humans
  • MB-204 is a fluorinated derivative of the U.S. FDA-approved adenosine A2a receptor antagonist, Istradefylline
  • Marvel Biosciences (MRVL) is unchanged, trading at $0.14 per share as of noon ET

Marvel (MRVL) has initiated its 7-day dose-ranging toxicology study for its lead molecule MB-204.

A vital step in preparation to initiate FDA Phase I human clinical trials, this animal trial tests the safety of new drugs before being able to run trials on humans.

MB-204 is a fluorinated derivative of the U.S. FDA-approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, which has been associated with a reduced risk of developing Parkinson’s disease, and Alzheimer’s disease and improved mood and concentration.

Rod Matheson, CEO of Marvel Biosciences, explained that the company had de-risked the development of its lead drug candidate, MB-204, with a strong understanding of its safety and risk profile, as it has redeveloped this candidate from an existing FDA-approved drug Istradefylline.

“We are on time and on budget to enter FDA Phase I human trials by early 2023. MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer’s Disease and Depression. Our studies, as noted in previous press releases, have been extremely encouraging. We look forward to introducing a novel product that we have full commercial rights to for a very large and growing market that is in real need of a new and effective approach to treatment.”

Dr. Mark Williams, Chief Science Officer of Marvel Biosciences, added that this is the final milestone experiment the team needed to execute in order to identify the optimal doses for the upcoming four-week GLP rat study, which in combination with their animal studies, will allow for the start of human clinical testing of MB-204.

“We are commencing the dog dose-ranging study shortly and will update the market on our progress shortly thereafter.”

Marvel Biosciences is a pre-clinical stage pharmaceutical development biotechnology company that utilizes synthetic chemical derivatives of known, off-patent drugs to develop new drugs.

Marvel Biosciences (MRVL) is unchanged, trading at $0.14 per share as of noon ET.


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