Three articles detailing the mid-stage trial results of Lykos Therapeutics’ MDMA-assisted therapy were retracted by the medical journal that published them, citing a failure by the authors to disclose a case of misconduct by an investigator.
The retraction Saturday by the journal Psychopharmacology came just a day after the FDA rejected Lykos’ treatment, a follow-up blow to a company that appeared to be leading the effort to bring to market a new generation of psychedelic treatments.
The journal said that the study authors, including Lykos’ CEO, failed to disclose a case of trial misconduct despite being aware of it. The retraction note says that the authors also didn’t remove data generated from the site where the misconduct took place.
The retraction centers on a 2015 case of sexual misconduct involving psychiatrist Donna Dryer and her unlicensed therapist husband Richard Yensen. The two were accused of taking advantage of a patient in the middle of a session at a facility in Canada and Lykos has since cut ties with both people.
The case was woven into larger ethical concerns about Lykos’ clinical development program for MDMA-AT — dubbed midomafetamine — which came under increasing scrutiny this summer as the company approached an FDA decision. Advisors to the FDA and outside reviewers at a key pricing organization raised concerns with Lykos’ failure to monitor positive adverse event data and functional unblinding of almost every patient given MDMA.
In a statement, Lykos acknowledged that it had failed to disclose the misconduct and regretted not doing so, and that the “authors chose to retain these data for sake of completeness.” The company said it believes it should have had the journal articles corrected, rather than retracted. The authors have since removed the data in question and Lykos said “the updated analyses were consistent with the original publications.”
Lykos CEO Amy Emerson and Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), were co-authors of two of the three retracted papers.
“As of this morning, MAPS has no knowledge of the details of the retraction beyond what has been stated here and published, therefore they have no comment,” a spokesperson for MAPS said in an email. The organization’s research on MDMA morphed into a public benefit corporation in 2014 before rebranding to Lykos earlier this year.
The journal retraction covers just one portion of the issues facing Lykos, whose future is now uncertain after the FDA’s rejection. The regulator has asked for another Phase 3 study, which Emerson said in a statement would take “several years” to conduct. She previously said in a late July interview with Endpoints News that the company was committed to additional fundraising but that a new trial would be a “different circumstance for raising money.” Lykos raised $100 million in January, enough to proceed with its near-term work, according to Emerson.
The biotech is now hoping to meet with the FDA and plead its case, asking for a reconsideration and “to further discuss the agency’s recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.” Lykos plans to provide an update on its path forward after the meeting.
Other psychedelics companies are more confident in their candidates and development programs. Compass Pathways is next up, advancing a Phase 3 study testing psilocybin in patients with treatment-resistant depression. There is also a burgeoning class of non-hallucinogenic neuroplastogens advancing early- to mid-stage programs that hope to shift the class away from hours-long trips to more accessible medicine.
But Lykos’ lead status has all but evaporated. The company said it plans to work “tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward.”