Lykos Therapeutics may have shed three-quarters of its staff in the wake of the FDA's rejection of its MDMA candidate for post-traumatic stress disorder, but the biotech’s new leadership believes the regulator may yet grant the company a path to approval.
Interim CEO Michael Mullette and chief medical officer David Hough, M.D., who took up their current positions as part of last month’s C-suite shakeup, have had a “productive meeting” with the FDA, the company said in a brief statement on Oct. 18.
“The meeting resulted in a path forward, including an additional phase 3 trial, and a potential independent third-party review of prior phase 3 clinical data,” the company said. “Lykos will continue to work with the FDA on finalizing a plan and we will continue to provide updates as appropriate.”
When the FDA turned down Lykos’ application for approval for its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy, in August, the regulator explained that it could not approve the treatment based on the data submitted to date. Instead, the agency requested that Lykos run another phase 3 trial to further weigh the efficacy and safety of MDMA-assisted therapy for PTSD.
At the time, Lykos said conducting a further late-stage study “would take several years,” and pledged to meet with the FDA to ask the agency to reconsider its decision.
It sounds like after sitting down with the regulator, the biotech’s new management has now accepted that any road to approval runs through a new trial, although Friday’s short statement didn’t go into details of the potential timeline.
The knock-back from the FDA wasn’t the only shock to rock Lykos in recent months. The same month, the journal Psychopharmacology retracted three articles about midstage clinical trial data weighing Lykos’ investigational MDMA therapy, citing protocol violations and “unethical conduct” at one of the biotech’s study sites. Weeks later, The Wall Street Journal reported that the FDA was investigating certain studies sponsored by the company.
Amid this summer's tumult, the company shed about 75% of its staff. At the time, Rick Doblin, Ph.D., the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), the parent company of Lykos, said he'd be leaving the Lykos board.