The battle over the board of psychedelic company Mind Medicine (NASDAQ: MNMD) continues with the latest volley being shot by the current company roster. MineMed published a report by Greenleaf Health, Inc. assessing the company’s MM-120 (lysergide D-tartrate) development strategy. The report’s main focus is to refute the claims by the group FCM MM Holdings that the company doesn’t need to engage in a Phase 2 study for MM-120.
In its battle to take control of the board, FCM MM Holdings which is affiliated with Jake Freeman, Scott Freeman and Chad Boulanger the group has put forth its own slate of board members that would be friendly to its plan. FCM believes that the company can pass Phase 2 for MM-120 in GAD and move directly into Phase 3, largely by relying on prior academic studies of LSD. The 2023 annual meeting for Mindmed shareholders is June 15, 2023.
The analysis – led by the former Director and Deputy Director of the Office of New Drugs at the U.S. Food and Drug Administration (FDA) and paid for by the current board of MindMed specifically focuses on MindMed’s strategy for MM-120 and its ongoing Phase 2b trial in patients with generalized anxiety disorder. The findings support MindMed’s view that this trial is essential to the development of MM-120 and contradicts the claim by FCM that the trial isn’t needed. The trial plans to enroll up to 200 participants who will receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are expected to be announced in late 2023.
MM-120 is a semisynthetic product of lysergic acid or LSD. The report wrote that prior published human and nonclinical experiences with LSD have primarily been with an LSD free base solution, while MindMed is developing the tartrate salt of D-lysergic acid diethylamide for solid oral administration. The study cited several previous LSD studies but noted that neither of the clinical trials referenced were dose-ranging studies. The report stated it was aware of no modern data demonstrating clinical response to doses of LSD other than 20 or 200ug. The study concluded:
“After review of the MM-120 regulatory history, relevant regulatory precedent, and applicable regulations and guidance, Greenleaf believes the ongoing Phase 2b dose-ranging clinical trial is an essential component to the development program for MM-120.”
MindMed continued to hit back at FCM’s claim by pointing out that the report said that to support FDA approval, the MM-120 program will need at least one, and more likely two, positive, adequate and well-controlled trials. The authors wrote, “The decision by MindMed to first initiate a dose-ranging Phase 2b study is appropriate and sound from a clinical and regulatory perspective.” It added, “The FDA’s feedback on the proposed developed program in no way suggests that it would accept a development program that skips important learnings from a well-designed and conducted Phase 2b trial in favor of moving directly to a large Phase 3 pivotal program.”
The authors went on to say that streamlining the process and moving straight to Phase 3 would substantially increase the chances of a failed trial and/or uninterpretable results. It also pushes back on using previous LSD studies describing them as informative but lacking detail.
“As we have consistently said, our regulatory strategy for MM-120 is the right one and was formulated over several interactions with FDA. Our ongoing Phase 2b study answers critical clinical and regulatory questions that will enable us to maximize the speed, efficiency and likelihood of success of our Phase 3 program,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Dr. Jenkins’ and Dr. Kweder’s extensive experience as senior officials inside FDA, and their objective analysis validating our approach, reinforces that there is no credible basis for FCM’s misplaced claim that MindMed could skip its Phase 2 study of MM-120 in GAD and go directly into Phase 3. Further, it underscores that by supporting this strategy of FCM’s, our shareholders would be putting not just the future of MM-120, but also their investments, at significant risk.”