Lykos Therapeutics said it remains dedicated to continuing development of its midomafetamine (MDMA) treatment for post-traumatic stress disorder (PTSD) after a US Food and Drug Administration (FDA) refusal.
Lykos has suffered a rocky couple of weeks, with the FDA refusing to approve its MDMA therapy in PTSD and asking for more trials. The company was also hit after three papers published about the Phase II study were pulled from journals.
The company will be reducing its workforce by 75%, with the remaining team to focus on ongoing clinical development, medical affairs, and engagement with the agency.
The clinical development programme for the drug will be taken over by Dr. David Hough, former vice president of research and development for J&J Innovative Medicine.
Hough said: "My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the agency's questions which will allow us to serve patients safely and effectively.”
Dr. Rick Doblin, the founder and president of MAPS, has also left his position on the Lykos board.
On 9 August, the FDA denied approval for the companies lead pipeline drug, issuing a complete response letter (CRL) stating that the MDMA therapy “could not be approved based on data submitted to date” and asked Lykos to conduct another Phase III trial. Lykos said in response it would ask the FDA to reconsider its negative decision.
This decision was expected after the FDA Advisory Committee (AdCom) voted against the therapy due to concerns about the drug’s efficacy. Other concerns were raised over ‘functional unblinding’ as the psychoactive effects of MDMA would make it clear to a patient they were not on placebo.
The panel also shared ethical concerns about various forms of alleged misconduct in Lykos’ trials. Previous reports have been made by a trial participant, alleging sexual misconduct during one of the trials. On 10 August, three journals pulled papers on the Phase II studies of Lykos’ MDMA, citing unethical conduct at study sites.
Lykos conducted two Phase III trials, MAPP1 (NCT03537014) and MAPP2 (NCT04077437), which enrolled around 200 people with PTSD. Both trials met their primary and secondary endpoints of PTSD symptom improvement and disability score assessments.
MDMA capsules have not been approved by any regulatory agency. The safety and efficacy of MDMA have not been established for the treatment of PTSD. Investigational MDMA is also being studied in other indications.
