Marvel Biosciences Selects CMAX Site for Phase I Trial of MB-204
Marvel Biosciences Corp. (TSXV:MRVL) has chosen CMAX, located in Adelaide, Australia, as the clinical site for its planned Phase I trial evaluating its drug candidate MB-204. The upcoming first-in-human study will feature a Single Ascending Dose design aimed at evaluating safety, tolerability, and pharmacokinetics, alongside exploratory biomarker and cognitive measures.
Selecting a clinical trial site represents a crucial operational transition for the company as it moves MB-204 out of preclinical evaluation and into human testing. Preclinical studies in models of autism spectrum disorder, Rett syndrome, and Fragile X syndrome previously demonstrated encouraging preliminary signals, building the foundation for clinical development.
The initiation of the study remains subject to regulatory and ethics approvals in Australia. If cleared, successful completion of the Single Ascending Dose trial is planned to lead into a Multiple Ascending Dose study to further evaluate the safety and dosing profile of the drug candidate.
Key points
- Marvel Biosciences selected CMAX in Adelaide, Australia, to conduct its Phase I trial for drug candidate MB-204.
- The trial will begin with a Single Ascending Dose design evaluating safety, tolerability, pharmacokinetics, and cognitive endpoints.
- A Multiple Ascending Dose study is planned to follow the initial trial phase.
- The study remains subject to regulatory and ethics approvals prior to enrollment.
- Preclinical studies showed supportive signals in models for autism spectrum disorder, Fragile X, and Rett syndrome.
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Where will Marvel Biosciences conduct its Phase I trial for MB-204?
Marvel Biosciences selected CMAX, located in Adelaide, Australia, as the site for its Phase I trial of MB-204.
What will the Phase I trial of MB-204 evaluate?
The Single Ascending Dose study will evaluate safety, tolerability, and pharmacokinetics, along with biomarker and cognitive endpoints.
What approvals are required before the MB-204 trial begins?
The study is subject to regulatory and ethics approvals before human testing can begin.