It seems it is business as usual for Mind Medicine, aka MindMed, (NASDAQ: MNMD) as the firm gave updates on its developmental drug programs on Monday.
The novel drug MM-120, which the company classifies as a “pharmaceutically optimized” version of what is referred to as LSD, is being developed primarily for the treatment of general anxiety disorder. The biotech firm in August 2022 began dosing in the 200-patient Phase 2b dose-optimization study of the drug candidate for the treatment of the disorder and said on Monday that “the study remains on track, with topline results expected to be announced in late 2023.”
A month after, the firm announced that a set of previously released positive topline data related to MM-120 being used to treat anxiety disorders has been published in a peer-reviewed scientific journal Biological Psychiatry.
The drug candidate is also being evaluated for the treatment of attention deficit hyperactivity disorder, with a 52-patient Phase 2a proof-of-concept trial is slated to assess the safety and efficacy of repeated low-dose MM-120 administration. The biotech firm also expects topline results in late 2023.
Sponsored · Selkirk Copper Mines
The updates come months after FCM MM Holdings, one of MindMed’s shareholders with a 6.1% stake, formally filed a complaint with the US Securities and Exchange Commission regarding various allegations against the company. The complaint refers to current allegations the firm faces: self-dealing, a lack of significant disclosure, false statements, and public statement fraud.
The complaint cited a concern on whether the biotech firm sufficiently communicated to investors the potential risk of MM-110 failing to obtain full US Food and Drug Administration product approval. The activist shareholder relayed that it has “conducted a rigorous review of publicly available data” after the firm terminated the drug candidate’s program and has concluded that “it is highly unlikely the FDA would have allowed the study to be performed in the US as written.”
The study was then conducted in Australia, yielding “topline results.” But when these were presented to the FDA, it was disclosed that the regulatory body requires the firm “to complete a myriad of pre-clinical safety studies prior to instituting additional clinical trials in the US.” CEO Robert Barrow then said these could take years and subsequently closed down the program altogether.
FCM MM Holdings is the holdings firm owned by MindMed’s co-founder Dr. Scott Freeman, who demanded changes in the firm earlier in 2022 and asked Barrow to step down upon filing the complaint.
READ: Mind Medicine Sees Co-Founder Become An Activist Shareholder Demanding Changes
The biotech firm also relayed on Monday that its drug candidate MM-402–the R-enantiomer of 3,4-MDMA–is being advanced into first clinical trial in 2023 for the treatment of core symptoms of autism spectrum disorder (ASD). The effects of MM-402 in a preclinical model of ASD are scheduled to be presented in the first half of 2023 as well.
The company began in October 2021 to develop R(-)-MDMA for treating symptoms related to autism spectrum disorder.
In September 2022, the firm also started a phase 1 investigator-initiated study aimed to evaluate the effects of MDMA or MDMA-like substances like MDA, Lys-MDMA, and Lys-MDA.
Mind Medicine Inc. last traded at $2.64 on the Nasdaq.
Information for this briefing was found via Sedar and the companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
