Lykos Therapeutics is undergoing a significant leadership transition following the FDA's rejection of its MDMA-assisted therapy for post-traumatic stress disorder (PTSD). CEO Amy Emerson, who has been with Lykos since its inception in 2014, will step down, with Michael Mullette, the current Chief Operating Officer, taking over as interim CEO. This change comes after the FDA requested an additional trial to address concerns about data collection, analysis, and potential ethics violations.
Leadership Changes at Lykos
Emerson will remain with the company as a senior advisor and board observer through the end of 2024. Jeff George, chairman of Lykos’ board, acknowledged Emerson’s pioneering work in the mental health field, particularly her efforts in advancing the MDMA therapy program. Mullette, who previously held leadership roles at Moderna and Sanofi, is expected to leverage his experience to guide Lykos through its regulatory challenges. In a statement, George called Mullette a “highly experienced leader” with the right skills to steer Lykos.
In addition to the CEO transition, David Hough has been promoted from senior medical advisor to Chief Medical Officer. Hough, who previously worked at Johnson & Johnson overseeing the development of Spravato (esketamine) for depression, will now lead Lykos’ clinical development program and efforts to resubmit the FDA application for its MDMA therapy.
Regulatory Setback and Reorganization
The FDA's rejection of Lykos' MDMA-assisted therapy followed concerns raised by the agency's internal reviewers regarding the integrity of the Phase III studies and potential scientific misconduct. The Psychopharmacologic Drugs Advisory Committee also voted against the candidate's approval. In response to the regulatory setback, Lykos announced plans to lay off approximately 75% of its workforce as part of a major reorganization.
The FDA's Complete Response Letter (CRL) indicated that Lykos' application could not be approved based on the submitted data and requested an additional late-stage trial to further evaluate the safety and efficacy of MDMA in treating PTSD. Lykos has stated its intention to request a meeting with the FDA to discuss the CRL and seek guidance on resubmission.
Future Directions and Therapeutic Approach
Lykos is currently re-evaluating its strategy for resubmitting its New Drug Application for MDMA-AT. According to Psychedelic Alpha, Hough believes Lykos has demonstrated sufficient efficacy, safety or benefit risk in some areas highlighted in the CRL and that it would be a point of discussion with the FDA about whether a new Phase 3 clinical trial would be needed, and if so, what size and design would it take.
Hough also indicated that Lykos is re-evaluating the role of therapy in conjunction with MDMA. He seeks broad generalizability so that it could be used with other evidence-based therapies as well and anticipates MDMA being used in a variety of contexts once approved. Lykos plans to establish an advisory board of PTSD experts to guide its resubmission approach, potentially including the inner-directed approach used in previous clinical trials.
