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The psychedelic industry was dealt a major blow this month when Lykos Therapeutics’ MDMA treatment was rejected by the FDA. The decision was the first for a psychedelic-assisted therapy, and the disappointment may help other biotech companies find the right path forward through difficult times.
The news wasn’t entirely unexpected after an FDA advisory committee rejected MDMA treatment. Several reasonsThese include concerns about recreational abuse, Lykos’ failure to collect data required by the FDA, and sexual misconduct during clinical trials. But other psychedelic biotech companies are still developing drug candidates, and some competitors see the drawbacks as a long-term positive.
“The FDA’s decision sends a warning to the industry that the agency will not tolerate any shortcuts,” said Doug Drysdale, CEO of Cybin, a biotech company with several psychedelic treatments in clinical trials. “While the decision may have an impact on psychedelic stocks in the short term, we are hopeful that in the long term the FDA’s rigor will lead to more robust research and outcomes for patients.”
Several more companies in mid- and late-stage trials may apply for FDA approval in the coming months and years.
Lycos’ Lessons
In its August decision, the FDA issued a full response letter to Lycos about its MDMA capsules for patients with post-traumatic stress disorder and required the company to conduct another Phase 3 trial to test safety and effectiveness. He said he was planning At the time, we requested a meeting with the FDA to reconsider the decision and recommend resubmission.
However, just weeks after this decision, Lycos announced job cuts. 75% of employees As part of its “restructuring” prior to resubmission, the company also brought in Dr. David Huff, former vice president of research and development at J&J Innovative Medicines, who led the development of the approved esketamine spray Spravato, to oversee clinical studies and “engagement with the FDA.”
“From a regulatory perspective, we believe we have a clear roadmap.”
Other biotech companies with psychedelic drugs like MDMA, ketamine, LSD and psilocybin are similarly targeting PTSD, depression, anxiety and other mental illnesses. And companies with treatments in mid- and late-stage research are taking notice of Lycos’ missteps. Lycos’ efforts to get approval for its PTSD treatment MDMA, which also includes a psychotherapy component, were also closely watched because of the therapeutic area in question. There are no new treatments.
But the rejection may be specific to Lykos, rather than representative of the psychedelic industry as a whole. A lesson that applies to other biotech companies is that working closely with the FDA and following through on requested information may be key.
“In our interactions with the FDA, we received valuable advice on the design of our Phase 3 depression program,” Drysdale said, “and we believe we have a clear roadmap from a regulatory perspective. Also, Lycos’ issues were very specific to the quality of the NDA submission, rather than a category issue.”
More decisions await
Lykos is the first biotech company to reach the FDA approval stage, but others are not far behind.
Compass Pathways is furthering clinical trials for its psilocybin therapy COMP360, which has received Breakthrough Therapy Designation from the FDA for the treatment of treatment-resistant depression, PTSD and anorexia nervosa. Top-line results A Phase 2 trial of PTSD patients showed improvement in severity of illness without adverse events. Expectations The company plans to release topline data from its Phase 3 study of COMP360 in TRD during the fourth quarter of this year.
Australia-based Incanex Healthcare is offering a psilocybin-based psychotherapy for the treatment of generalized anxiety disorder and is due to enter Phase 2b trials soon. Positive Top-Line Results The company is also conducting late-stage trials of a THC pill treatment for obstructive sleep apnea and a cannabinoid-enhanced combination treatment for rheumatoid arthritis.
Cybin is evaluating psilocybin therapies and is currently in Phase 3 trials with CYB003 for treating patients with major depressive disorder. beginning The company announced in June that the new drug had been granted what is known as “breakthrough designation by the FDA as an adjunct psychedelic-based therapy for the potential treatment of MDD.” Cybin completed meetings with the FDA this month to finalize the design of a Phase 3 study that is scheduled to begin in late summer 2024.
Functional unblinding was cited as one of the reasons for rejecting Lycos’ MDMA therapy by the FDA ad committee, and is one of the major clinical challenges for a therapy that contains significant hallucinogenic effects. Cybin pointed to design elements in the study that were intended to prevent unblinding. 3-arm design In the high-dose, mid-dose, and placebo groups, participants may be less likely to know whether they are receiving a therapeutic or sub-therapeutic dose, and Cybin implements firewalls and utilizes remote assessors to mitigate the risk of unblinding.
MindMed, a biotechnology company studying LSD as a treatment for generalized anxiety disorder, also completed meetings with the FDA in June as it worked out the design of its pivotal Phase 3 trial, which also uses a graded dosing approach and is expected to move into late-stage research later this year.
“we As planned “We expect to initiate a Phase 3 clinical program for our MM120 orally dissolving tablet in GAD later this year and look forward to sharing additional details about our pivotal program design in the coming months,” MindMed CEO Rob Barrow said in June.
