Lykos Therapeutics, still reeling from US Food and Drug Administration rejection of the company’s capsule formulation of the psychedelic drug midomafetamine for the treatment of post-traumatic stress disorder (PTSD), announced a reorganization plan on 15 August that includes a 75% workforce reduction.
The company’s remaining staff and newly recruited senior medical advisor David Hough will focus on clinical development, medical affairs and interactions with the FDA as Lykos responds to the complete response letter (CRL) the agency issued on 9 August. The FDA essentially said another Phase III clinical trial would be needed for it to consider the company’s new drug application for MDMA in PTSD, but Lykos said it plans to ask the agency to reconsider the CRL