Lykos Therapeutics is undergoing a period of significant transition following the FDA's rejection of its midomafetamine capsules, an MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The company is grappling with leadership changes, board reshuffling, and financial restructuring as it seeks a path forward for its pioneering treatment.
Leadership Transition
Amy Emerson, who has led Lykos Therapeutics as CEO since 2014, has stepped down from her position. Emerson's departure follows the FDA's decision not to approve the MDMA-based therapy, a setback for the company and the broader psychedelic medicines sector. Michael Mullette, a pharma industry veteran with experience at Moderna and Sanofi, has been appointed as interim CEO. Emerson will remain in an advisory role until the end of the year and serve as an observer on the Lykos board. Dr. David Hough, formerly a medical advisor, has been promoted to Chief Medical Officer, taking the lead on clinical development and engagement with the FDA.
Board Reshuffling
In addition to the CEO transition, Lykos has seen the departure of five board directors: independent directors Jeff George, Scott Giacobello, and Jason Pyle, as well as Gisselle Acevedo and Kris Lotlikar. To fill these vacancies, the Multidisciplinary Association for Psychedelic Studies (MAPS), a Lykos shareholder, has appointed Ron Beller and Joe Green to the board. Dan Grossman will remain as an independent director, alongside Dawn McCollough and Suprotik Basu.
Challenges and Future Strategy
The FDA's Complete Response Letter (CRL) to Lykos cited the need for an additional Phase III trial to better illustrate the safety and efficacy of midomafetamine. The agency raised concerns about bias in the existing data. Prior to the FDA's decision, the Institute for Clinical and Economic Review (ICER) had also questioned the design of Lykos's clinical studies, pointing to potential unblinding and other methodological issues. Furthermore, the journal Psychopharmacology retracted three articles about the treatment due to protocol violations and undeclared competing interests.
Interim CEO Mike Mullette acknowledged the challenges ahead, stating that the company is working to engage with the FDA and bring the treatment to patients in need. Lykos is collaborating with shareholders, including MAPS, to secure financing and refine its strategy for the development of MDMA-assisted therapy. The company plans to provide a more detailed update on its strategy in the near future.
PTSD: A Significant Unmet Need
According to the American Psychiatric Association, PTSD affects approximately 3.5% of adults in the United States annually, with an estimated lifetime prevalence of 6%. The condition is more prevalent among Latinos, African Americans, and Native Americans/Alaska Natives, as well as women and veterans. The FDA's rejection of Lykos's MDMA therapy represents a setback for the treatment of PTSD, a condition for which new treatment options have been limited for over two decades. Amy Emerson stated that the request for another study is deeply disappointing, especially for the millions of Americans with PTSD who have not seen any new treatment options in over two decades.
