looks like business as usual Mind Medicine, aka MindMed (NASDAQ: MNMD) The company provided an update on its drug program in development on Monday.
A new drug, MM-120, which the company classifies as a “pharmacologically optimized” version of what it calls LSD, is being developed primarily for the treatment of generalized anxiety disorder. On Monday, it began dosing in a Phase 2b dose optimization study of its disorder treatment candidate in 200 patients, and on Monday said, “The study is progressing well and topline results will be announced later. Scheduled for 2023.
A month later, the company announced that a series of previously released positive topline data related to MM-120 being used to treat anxiety disorders had been published in a peer-reviewed scientific journal. Announced biological psychiatry.
This drug candidate is also being evaluated for the treatment of attention-deficit hyperactivity disorder, where a Phase 2a proof-of-concept study in 52 patients demonstrated the safety and efficacy of multiple doses of low-dose MM-120. will be evaluated. Biotech companies are also expecting top-line results in the second half of 2023.
The update comes months after one of MindMed’s 6.1% shareholders, FCM MM Holdings, filed a formal complaint with the U.S. Securities and Exchange Commission regarding various allegations against the company. am. The complaint addresses current allegations facing the company: self-dealing, lack of material disclosure, false statements, and fraud in public statements.
The complaint raises concerns about whether the biotech company adequately communicated to investors the potential risk that MM-110 might not receive full U.S. Food and Drug Administration product approval. Activist shareholders said the company “conducted a rigorous review of public data” after it exited its program of drug candidates, adding that “it is highly probable that the FDA will authorize the study to be conducted in the United States in writing.” low,” he concluded. ”
The study was then conducted in Australia and yielded ‘top-line results’. However, when these were presented to the FDA, it became clear that the regulatory agency required the company to “complete numerous preclinical safety studies before initiating additional clinical trials in the United States.” became. CEO Robert Barrow said this could take years, before shutting down the program entirely.
FCM MM Holdings is a holding company owned by MindMed co-founder Dr. Scott Freeman, who requested a change of company in early 2022 and filed a complaint against Barrow asking him to resign.
read: Mind Medicine sees co-founders become activist shareholders demanding change
The biotech company said Monday that its drug candidate, MM-402 (the R-enantiomer of 3,4-MDMA), will enter the first market in 2023 for the treatment of core symptoms of autism spectrum disorder (ASD). I was told that it is in clinical trials. Efficacy of MM-402 in preclinical models of ASD is expected to be announced in the first half of 2023.
In October 2021, the company began developing R(-)-MDMA to treat symptoms associated with autism spectrum disorders.
In September 2022, the company also initiated a Phase 1 investigator-led study aimed at evaluating the effects of MDMA or MDMA analogues such as MDA, Lys-MDMA and Lys-MDA.
Mind Medicine traded at $2.64 on the Nasdaq.
The information in this briefing was discovered through Sedar and the companies mentioned. The author has no securities or affiliation associated with this organization. It is not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing any security. The author holds no license.