Mydecine Innovations Group Inc (OTC:MYCOF, NEO:MYCO). announced that it plans to supply its lead drug candidate, MYCO-001, for a multi-site smoking cessation study being conducted at Johns Hopkins University (JHU), New York University (NYU), and the University of Alabama Birmingham by top drug and substance use researcher Dr. Matthew Johnson.
The Denver, Colorado-based biopharma company focused on the treatment of mental health disorders and addiction, revealed that Dr. Johnson has received a U01 grant from the National Institute on Drug Abuse (NIDA) to fund the study, making it the first time in over 50 years that the US government has funded a study of a psychedelic compound for therapeutics.
Mydecine, which exercises a five-year research agreement with JHU to study the impact of psychedelics on smoking cessation amongst other initiatives, announced in September that it had partnered with Dr. Johnson to complete a seamless Phase 2/3 smoking cessation clinical trial for MYCO-001.
READ: Mydecine Innovations announces MYCO-001 Seamless Phase 2/3 Smoking Cessation clinical trial
“Projected to launch in Q1 2022, the Phase 2/3 clinical trial will run concurrently with the newly announced multi-state study,” said the company. Mydecine believes both studies will serve to provide further supportive efficacy and safety data for MYCO-001.
In a statement, Mydecine CEO Josh Bartch said: “The NIDA’s decision to fund the continuation of Dr. Johnson’s smoking cessation study is a strong validator of medicines, such as our MYCO-001 formulation, for the treatment of smoking cessation.”
“Previous clinical results by Dr. Johnson and his team at Hopkins have shown six-month abstinence rates as high as 80%, which is unheard of in the addiction space. NIDA ranked this study incredibly high, which further solidifies our approach to treat this deadly addiction.”
Bartch said Mydecine is “excited” to support Dr. Johnson and his team in this concurrently running study which “we believe will add a significant benefit to support our 2/3 seamless design”.
“We have made significant progress advancing our MYCO-001 clinical trials for smoking cessation to date with JHU,” added Bartch. “The opportunity to play an integral role in this landmark study by supplying our lead drug candidate, not only offers a significant opportunity to further advance our drug development through safer and more viable results, but demonstrates Mydecine’s leadership position in the emerging psychedelic-assisted psychotherapy industry.”
Mydecine’s MYCO-001 is pure psilocybin from natural fungal sources.
“The incredibly promising clinical data that has been accumulated by the evolving psychedelic therapeutics industry to date makes these types of collaborations potentially a game-changer in smoking cessation,” said Mydecine CMO Dr Rakesh Jetly. “The US government’s recognition of this valuable data and their support in advancing the development of psychedelic-based therapy to help create a more effective treatment option supports our mission to bring these needed drugs to the forefront of the market.”
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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