Lykos Therapeutics is capping off an awful week with a massive reorganization, laying off about 75% of staff in the aftermath of an FDA rejection and the retraction of three research papers on the biotech’s MDMA treatment due to protocol violations at a clinical trial site.
Rick Doblin, Ph.D., the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), the parent company of Lykos, is also leaving his position on the Lykos board.
“After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that Lykos will still move forward continuing clinical research that addresses the FDA’s questions,” Doblin said in an Aug. 15 release.
Lykos’ downslide started just six days ago when the FDA rejected the company’s MDMA-assisted therapy treatment for post-traumatic stress disorder. The move was not unexpected, as an advisory panel assembled by the agency had previously voted against approval. The regulator asked Lykos to run another phase 3 trial to gather more data on the treatment’s safety and efficacy.
Just two days later, the journal Psychopharmacology retracted three research papers on results from Lykos’ phase 2 trials assessing MDMA. The studies included in the retracted articles were not the same studies underpinning the request for FDA approval. Authors of the studies included Lykos CEO Amy Emerson and researchers associated with MAPS.
Lykos is not giving up the pursuit of FDA approval, and, as a result, has decided to lay off 75% of its workforce—about 75 people—to focus on getting MDMA across the regulatory finish line. The remaining employees will focus on ongoing clinical development, medical affairs and engagement with the FDA, according to the release.
The embattled biotech is also bringing industry veteran David Hough, M.D., on board as senior medical adviser to lead the effort to resubmit Lykos’ MDMA treatment to the FDA. A psychiatrist, Hough served in various leadership roles over 17 years at J&J Innovative Medicine and was most recently the chief medical officer at Freedom Biosciences.