Lykos Wraps Up Turbulent Week with 75% Staff Cuts Following FDA Rejection and Publication Retractions

Lykos Therapeutics is concluding a challenging week with a major reorganization, including laying off 75% of its staff. This drastic move follows a Food and Drug Administration (FDA) rejection and the retraction of three research papers on their MDMA treatment due to protocol violations at a clinical trial site. The company is also parting ways with its founder, Rick Doblin, in this significant shake-up.

FDA Nixes MDMA PTSD Therapy: How Other Psychedelic Firms Plan to Steer Clear of the Same Pitfall

In just a few months, Lykos Therapeutics went from a leading contender in psychedelic medicine to a cautionary tale. The FDA rejected its MDMA-assisted PTSD therapy and called for an additional clinical trial to assess safety and efficacy. After a nine-hour meeting, committee members unanimously agreed that the data were insufficient to support MDMA’s market entry. Despite this, they acknowledged that Lykos’ treatment holds promise. 

Given the potential of the treatment, Lykos sought FDA approval for MDMA capsules combined with psychological intervention, known as MDMA-assisted therapy, for PTSD. Before the meeting, the FDA expressed concerns about conducting a fair clinical trial for MDMA treatment. The FDA noted in briefing documents that “midomafetamine produces profound alterations in mood, sensation, suggestibility, and cognition,” making blinding nearly impossible. The FDA’s rejection followed an advisory panel’s negative vote on approval regarding the use of MDMA treatment for PTSD. Specifically, the Psychopharmacologic Drugs Advisory Committee voted 9-2 against the effectiveness of Lykos’ MDMA therapy for PTSD. Additionally, it voted 10-1 against whether the therapy’s benefits outweighed the risks, despite a proposed risk evaluation and mitigation strategy (REMS). Although the FDA isn’t obligated to follow the committee’s recommendations, it usually does. Consequently, the agency requires Lykos to conduct another phase 3 trial for more safety and efficacy data.

“We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” stated Amy Emerson, Lykos CEO, on June 4th in response to the outcome.

A One-Two Punch: 3 MDMA Treatment Articles Retracted Over Unethical Conduct

Following the FDA rejection, Psychopharmacology retracted three papers from an early MDMA study. The retraction cited “unethical conduct” at a research site involved in the 2015 MP4 phase 2 trials of midomafetamine, an MDMA capsule combined with psychological intervention. Stat reported that a therapist faced allegations of practicing without a license and sexually assaulting a MAPS trial participant.

In light of these issues, the authors include Lykos CEO Amy Emerson and others associated with Lykos’ parent company, Multidisciplinary Association for Psychedelic Studies (MAPS), or its subsidiary, MAPS Public Benefit Corporation. While MAPS fully funded and organized the trials through its subsidiary, Psychopharmacology claims the authors did not fully disclose a potential competing interest, which Lykos disputes.

According to a Lykos spokesperson, the journal raised concerns about conflict of interest disclosure. The authors, however, properly disclosed their contributions, funding sources, and affiliations. Lykos maintains that the articles are scientifically sound and offer valuable insights into potential PTSD treatments. Of note is that these violations impacted the protocol but were not linked to the data submitted for FDA approval.

Lykos Downsizes by 75% to Refocus on MDMA Approval; Hires Industry Veteran to Lead Resubmission

Lykos is not abandoning its pursuit of FDA approval. The company will lay off 75% of its workforce—about 75 people—to concentrate on securing MDMA approval. Remaining employees will focus on clinical development, medical affairs, and FDA engagement.

Additionally, Lykos is bringing in industry veteran David Hough, M.D., as senior medical advisor. Hough, who previously led various roles at J&J Innovative Medicine and was the chief medical officer at Freedom Biosciences, will oversee the resubmission of Lykos’s MDMA treatment to the FDA.

The company aims to streamline its efforts and enhance its chances of regulatory success with this new leadership and a leaner team. Despite the disappointment among researchers and patient advocates, including veterans groups who lobbied for approval, the effort to bring psychedelics into mainstream medicine continues. Two other companies are advancing phase 3 trials for psilocybin, the active compound in magic mushrooms, to treat depression.

Author

Bernice Lottering