MB-204 / Marvel Biosci - LARVOL DELTA

Marvel to File for Orphan Drug Designation with The U.S. FDA for MB-204 as a Treatment for Rett Syndrome (Newsfile) - "Marvel Biosciences Corp...announced plans to file for Orphan Drug Designation (ODD) with the U.S. Food and Drug Administration (FDA) for its lead compound, MB-204, as a potential treatment for Rett Syndrome...This decision follows strong preclinical data showing MB-204's sustained benefits, outperforming Trofinetide-the only FDA-approved treatment for the disease. Marvel aims to leverage ODD benefits to accelerate MB-204's clinical development and provide new hope to patients and families."

Orphan drug • Preclinical • Genetic Disorders

Marvel Biosciences Announces Notice of Allowance of Composition of Matter Patent for Its Lead Molecule MB-204 in China (Yahoo Finance) - "Marvel Biosciences Corp...today is pleased to announce that the Chinese patent office has issued a notice of allowance for its lead compound MB-204. This is the first allowance worldwide for this family...'MB-204 is a novel fluorinated derivative of the approved Parkinson's drug Istradefylline, which we are developing for other neurological diseases such as autism, depression and Alzheimer's Disease.'"

Patent • Alzheimer's Disease

Marvel Biosciences to Collaborate with Tau Expert Dr. Emmanuel Planel (BioSpace) - "Marvel Biosciences Corp...is pleased to announce a collaboration with Professor Emmanuel Planel of Laval University to study the acute effect of MB-204 on Tau protein phosphorylation in mice. Abnormal tau phosphorylation is a hallmark of neurodegenerative diseases such as Alzheimer's disease."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

MB-204: A Novel Adenosine A2a Antagonist for AD, ADHD and Depression (AAIC 2023) - "MB-204 appears to be an excellent pre-clinical candidate for the treatment of A2a associated conditions"

ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • ADORA2A

MB-204: A Novel Adenosine A2a Antagonist for AD, ADHD and Depression (AAIC 2023) - "MB-204 appears to be an excellent pre-clinical candidate for the treatment of A2a associated conditions"

ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • ADORA2A

MB-204: A Novel Adenosine A2a Antagonist for AD, ADHD and Depression (AAIC 2023) - "MB-204 appears to be an excellent pre-clinical candidate for the treatment of A2a associated conditions"

ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • ADORA2A

MB-204: A Novel Adenosine A2a Antagonist for AD, ADHD and Depression (AAIC 2023) - "MB-204 appears to be an excellent pre-clinical candidate for the treatment of A2a associated conditions"

ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • ADORA2A

Marvel Biosciences Completes a Critical Manufacturing Milestone Required to Enter Phase 1 Human Trials Targeting Alzheimer's Disease and Depression (Yahoo Finance) - “Marvel Biosciences Corp...and its wholly owned subsidiary, Marvel Biotechnology Inc…are pleased to announce that it has successfully completed a multi-kilogram scale run under current good manufacturing practices (‘cGMP’) of the active pharmaceutical ingredient (API) of the Company's lead asset MB-204 in partnership with Zhejiang Ausun Pharmaceutical Co., Ltd. (‘Ausun’). The cGMP material obtained from this study will be utilized in the Company's upcoming Phase 1 clinical study.”

Commercial • Alzheimer's Disease • CNS Disorders • Depression

Marvel Biosciences Initiates the Next Milestone Study for its Lead Asset MB-204 Targeting Alzheimer's and Depression (Newsfile) - "Marvel Biosciences...announce that it has initiated its 7-day dose-ranging, toxicology study, using rats, for its lead molecule MB-204. This is a vital step in preparation to initiate FDA Phase I human clinical trials. 'We have significantly de-risked the development of our lead drug candidate MB-204 and have a strong understanding of its safety and risk profile, as we have 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'....'This is the final milestone experiment we need to execute in order to identify the optimal doses for our upcoming 4-week GLP rat study, which in combination with our dog studies, will allow us to start human clinical testing of MB-204.'"

New P1 trial • Preclinical • Alzheimer's Disease • CNS Disorders • Depression

Marvel Biosciences' Lead Drug Candidate MB-204 Successfully Targets Brain Receptor Important for Alzheimer's Disease and Depression (Yahoo Finance) - "Marvel Biosciences Corp...announced today that in a pre-clinical mouse study conducted by the Company, its lead drug candidate MB-204 successfully entered the brain and occupied its target, the adenosine A2a receptor. The adenosine A2a receptor has been validated by numerous scientific studies that it plays a significant role in various pathologies such as Alzheimer's Disease and depression."

Preclinical • Alzheimer's Disease • CNS Disorders • Depression

Marvel Biosciences Advances Closer to Human Trials After the Successful Completion of a Second Maximum Tolerated Dose Study, a Critical Milestone Towards FDA Clinical Studies (Yahoo Finance) - “Marvel Biosciences Inc…is pleased to announce it has completed its maximum tolerated dose (MTD) toxicology study in dogs for its product MB-204, further validating the Company's lead drug candidate low toxicity characteristic….‘We are very excited that this recent toxicology study has gotten us one step closer to beginning our human clinical trials within the first quarter of 2023’….Marvel is developing MB-204 for the treatment of depression and Alzheimer's Disease, as well NASH associated liver fibrosis."

New trial • Preclinical • Alzheimer's Disease • CNS Disorders

Marvel Biosciences Corp. to Present at the 22nd International Conference on Alzheimer’s Drug Discovery (Yahoo Finance) - "Marvel Biosciences Corp...is pleased to announce that it has been accepted to present at the start-up company forum at the 22nd International Conference of Alzheimer's Drug Discovery, a virtual conference on October 4 and 5th, 2021 hosted by the Alzheimer's Drug Discovery Foundation....'Our pre-clinical data to date has shown great promise in terms of efficacy and safety of our lead compound MB-204'....Marvel's lead compound asset MB-204 is being developed for neurological conditions such as depression and anxiety, Alzheimer's and ADHD."

Preclinical • Review • Alzheimer's Disease • CNS Disorders • Depression • General Anxiety Disorder