MB-204

Marvel’s lead compound (MB-204) is a novel fluorinated derivative of Istradefylline, an FDA-approved adenosine A2a receptor antagonist. Designed to maximize therapeutic benefits, MB-204 is developed to work faster, more effectively, and with lower doses compared to existing treatments. Preclinical studies have demonstrated MB-204’s potential to address a range of conditions, including Alzheimer’s disease, depression, anxiety, and autism. MB-204 is currently being examined in preclinical models of Rett syndrome and Fragile X syndrome.

The compound’s mechanism of action involves modulating the A2A adenosine receptor, a well-validated target implicated in numerous neurological and psychiatric disorders. MB-204’s efficacy has been validated in independent laboratories, showing significant promise in reversing symptoms and underlying disease mechanisms. With completed cGMP synthesis, toxicology studies, and preparations for Phase 1 clinical trials, MB-204 is poised to become a game-changing therapy for patients suffering from these challenging conditions.

 

Emerging roles of dysregulated adenosine homeostasis in brain disorders with a specific focus on neurodegenerative diseases

Read full article here: https://pubmed.ncbi.nlm.nih.gov/34635103/

 

CD39-mediated ATP-adenosine signalling promotes hepatic stellate cell activation and alcoholic liver disease

Read full article here: https://pubmed.ncbi.nlm.nih.gov/34033815/

 

Proposed Development Timeline:

 Q1 2026

 MILESTONES

• cGMP drug product manufactured and released

• GLP toxicology studies completed in rats and dogs with acceptable safety margins (NOAEL)

• Non-dilutive funding secured for pediatric liquid formulation development (in progress; completion expected by end of Q1)

Q2 2026

CLINICAL – Phase 1
First-in-human dosing in healthy volunteers
Initial safety and tolerability readouts
Human pharmacokinetics (PK) characterization

NON-CLINICAL

Anticipated composition-of-matter patent progression (US/EU/JP)

Q4 2026

CLINICAL – Phase 1

Multiple-ascending-dose cohorts completed
Dose–exposure relationship
Confirmation of CNS-relevant exposure


NON-CLINICAL

Fragile X preclinical efficacy readouts to support orphan indications

Q1 2027

CLINICAL – Phase 1

PK and exploratory biomarker analysis

Target-engagement signals evaluated
Data package supports Phase 2 dose rationale

NON-CLINICAL

IP expansion activities, including liquid formulation patent filings

 

*Note: timelines may be subject to change.

Marvel Non-Hallucinogenic Neuroplasticity Program

Marvel has identified a series of related compounds that appear to be potent, fast acting, water soluble and orally available small tryptamine derivatives that have anti-depressive activity but no overt hallucinatory activity in pilot studies.

Second Program: Safer Neuroplastic Promoting Drugs

 

Marvel has identified a set of molecules inspired by the tryptamine class of psychedelics that are:

 

  • Fast acting anti-depressants
  • Orally available
  • Water soluble
  • No evidence of hallucinations
  • Lead better than fluoxetine (Prozac, p<0.005)