Lykos Therapeutics has announced a major reorganization in response to the FDA’s recent decision regarding the company's new drug application (NDA) for midomafetamine capsules, intended for the treatment of post-traumatic stress disorder (PTSD) in adults.
As part of the reorganization, Lykos will significantly reduce its workforce by approximately 75%, concentrating its remaining resources on clinical development and FDA engagement. The company says it remains committed to advancing midomafetamine, despite the FDA’s feedback, and will focus on generating the necessary clinical data to support the drug's approval.
The restructuring includes the appointment of David Hough, a seasoned pharma executive and former Janssen leader, as senior medical advisor to guide the company's clinical development and regulatory strategies. Also, Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has stepped down from his position on the Lykos board.
Lykos' leadership has expressed confidence in Hough’s ability to navigate the regulatory challenges, leveraging his extensive experience with similar approvals. The company’s newly formed independent advisory board will provide additional guidance.
Last week, Lykos revealed that it had received a CRL from the FDA, who said the NDA could not be approved based on the submitted data and requested an additional phase 3 trial to further study the safety and efficacy. The concerns in the CRL reflected those from the FDA AdComm meeting in June, where the treatment was voted against due to efficacy and risk-benefit issues. There were also concerns about the panel's expertise and the nature of the discussion, which, according to the company, extended beyond the scientific content.
Lykos had said it plans to ask the agency to reconsider its decision. The treatment would have been the first psychedelic-assisted therapy for PTSD in over two decades.