Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
Lykos Therapeutics can’t seem to catch a break. Months after the FDA declined to approve its MDMA-assisted post-traumatic stress disorder therapy, the psychedelics-focused drugmaker announced on Tuesday that five board directors have left the company.
Independent directors Jeff George, Scott Giacobello and Jason Pyle have all resigned from their respective roles, Lykos revealed in its press release, adding that Gisselle Acevedo, also independent, had likewise decided to step down from her post last month.
Joining the four departing directors is Kris Lotlikar, who was appointed onto Lykos’ board by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit that works to improve awareness and understanding of psychedelic substances. MAPS is a Lykos shareholder.
To fill the newly empty spots on the biotech’s board, MAPS has named two new directors to occupy its designated seats: Ron Beller and Joe Green. Dan Grossman, who had previously occupied one of the two allotted MAPS seats, will stay with Lykos as an independent director. Dawn McCollough, independent, as well as Preferred Director Suprotik Basu, will likewise remain with the biotech.
Tuesday’s board transitions “come as the company continues to work towards resubmission of its new drug application and secures financing to support its strategy,” Lykos indicated in its news release, adding that the company is currently working with its shareholders—including MAPS—to “secure an aligned go-forward financing strategy.” Lykos promised to provide a more detailed update regarding its strategy moving forward “at the appropriate time.”
In August 2024, the FDA handed Lykos a particularly devastating rejection for its investigational MDMA-assisted therapy for post-traumatic stress disorder. According to the Complete Response Letter, the regulator asked Lykos to run another Phase III study to better illustrate the safety and efficacy of the therapy, noting that its application “could not be approved based on data submitted to date.”
The fallout from the rejection was severe. Just a week after the regulatory rebuff, Lykos announced that it was laying off 75% of its workforce in an effort to cut costs and muster enough resources to support continued development of the MDMA candidate. Rick Doblin, founder and president of MAPS, also left his post on Lykos’ board. In September, the biotech revealed that former CEO Amy Emerson would also be resigning.
In the weeks leading up to the FDA’s rejection, Lykos’ MDMA therapy became the subject of heavy controversy focused particularly on the conduct of its Phase III trials, in which there were “substantial concerns” surrounding the integrity of the data, according to a June 2024 report from the Institute for Clinical and Economic Review (ICER). In particular, the ICER flagged issues regarding the enrollment and methodology of the study.
Lykos’ trials were “essentially, unblinded, with nearly all patients who received MDMA correctly identifying that they were in the MDMA arm of the trials.,” the ICER report read. The watchdog also cited reports that patients who were recruited into the programs already had “very strong beliefs” about the benefits of MDMA.
Since the rejection, Lykos has already reached out to the FDA for guidance on taking the candidate forward, announcing in October 2024 that it had concluded a “productive” meeting with the regulator.
