For Lykos Therapeutics and the company’s would-be MDMA-assisted therapy for post-traumatic stress disorder (PTSD), the hits just keep coming.
Earlier this month, Lykos was struck by an FDA rejection, research paper retractions and layoffs. Now, the FDA is looking into certain studies sponsored by the company, The Wall Street Journal reports.
The FDA is widening its scrutiny of the clinical trials testing Lykos’ recently rejected drug and last week interviewed at least four people about the Lykos-sponsored studies, according to WSJ, which cited individuals close to the matter.
FDA investigators specifically asked about whether side effects went unreported in the studies, the newspaper explained.
“Lykos is committed to engaging with the FDA and addressing any questions it raises,” a company spokesperson told WSJ. She added that the biotech looks forward to meeting with the FDA about issues raised as part of its recent PTSD rejection.
Lykos has been on a roller coaster ride ever since the FDA snubbed its midomafetamine (MDMA) therapy in patients with PTSD earlier this month. The company was seeking approval of its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy.
At the time, the regulator requested that Lykos run another phase 3 study to garner more data on the safety and efficacy of MDMA-assisted therapy for PTSD. Lykos, for its part, said it planned to meet with the FDA to ask the agency to reconsider its decision.
Shortly thereafter, the journal Psychopharmacology yanked 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.
According to retraction notices issued around the middle of August, the authors whose names were attached to the papers confirmed they were aware of the protocol violations when the articles were submitted for publication but never mentioned them to the journal or excluded the data sourced from the site in question.
Psychopharmacology’s retraction decision also raised issues around a previously known case of “unethical therapist conduct” tied to a phase 2 study in 2015, Lykos told Fierce Biotech earlier this month.
The company said it disagreed with the retraction decision and believed the issue would have been better solved through corrections.
“Lykos has filed an official complaint with the Committee on Publication Ethics (COPE) to review the process through which the journal came to this decision,” a company spokesperson said at the time.
Meanwhile, capping off Lykos’ turbulent month, the company recently said it would lay off about 75% of its staff in the aftermath of the FDA snub.
Rick Doblin, Ph.D., the founder and president of Lykos’ parent MAPS, also decided to exit his position on the Lykos board.
Lykos’ argued that the job cuts, which will affect about 75 people, would help the company focus on its goal of getting its MDMA-assisted therapy across the regulatory finish line.
The employees who will retain their jobs will prioritize ongoing clinical development, medical affairs and engagement with the FDA, according to a Lykos release.