Psychopharmacology has pulled three articles about midstage clinical trial data assessing Lykos Therapeutics’ investigational MDMA candidate for treating post-traumatic stress disorder (PTSD). The journal cited “unethical conduct” at a research site as the reason for the retraction.
The article removals are related to protocol violations at a study site that was involved in phase 2 trials assessing midomafetamine, an MDMA capsule designed to be delivered alongside psychological intervention that was just denied FDA approval on Friday. The studies included in the retracted articles were not the same studies that underpinned Lykos’ request for FDA approval.
Authors with their names attached to the papers have subsequently confirmed they were aware of the protocol violations when the articles were submitted for publication but didn’t say anything about it to Psychopharmacology nor exclude the data coming from the site, according to the retraction notices.
One of the authors is Lykos CEO Amy Emerson, while several other authors are associated with Lykos’ parent company Multidisciplinary Association for Psychedelic Studies (MAPS) or a MAPS subsidiary dubbed MAPS Public Benefit Corporation.
“Lykos has been made aware that three articles that had been previously published including pooled data from a 2015 phase 2 study have been retracted by Psychopharmacology,” a company spokesperson told Fierce Biotech in an emailed statement. “Lykos disagrees with this retraction and believes the identified issues should have been addressed 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.”
MAPS fully funded the trials and the company’s subsidiary organized the trials, as stated in the funding declarations. However, Psychopharmacology says the authors didn’t fully declare a potential competing interest, a claim Lykos denies.
“The journal also raised an issue regarding disclosure around conflict of interest, however, the authors did appropriately disclose contributions, funding sources and affiliations,” the biotech spokesperson said.
Lykos went on to say that the articles “remain scientifically sound” and present important contributions to the field of potential PTSD treatments.
“The journal’s retraction decision cites concern with the inclusion of data from the 2015 MP4 phase 2 study where there was a previously known, widely reported case of unethical therapist conduct,” according to the Lykos spokesperson.
That therapist has been accused of practicing without a license and of sexually assaulting a MAPS trial participant, according to Stat.
“Originally, the publication authors chose to retain these data for sake of completeness, but that should have been disclosed to the journal and was not,” the Lykos spokesperson continued. “The ethical violations at issue were reported to the FDA, Health Canada and the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), and a public statement was issued in May 2019. However, we did not disclose the violations to the journal itself, an additional step we should have taken and regret not doing.”
The MDMA-focused biotech initially requested a correction to the journal, the Lykos spokesperson said, adding that the authors removed the data from the four participants treated at the site. Afterward, the updated analyses remained consistent with the original publications.
The Journal of Traumatic Stress has decided that a correction is the proper response for another article that included data from the same study, the spokesperson added.
Allison Feduccia, Ph.D., an author of all three papers and affiliate of MAPS Public Benefit Corporation, said she agreed with the retraction but disagreed with the wording of the notice, according to the retraction.
Meanwhile, several other authors including MAPS founder Rick Doblin, Ph.D., disagree with the retraction. Lykos’ CEO didn’t respond to the publisher about the retraction, according to Psychopharmacology.
The retractions closely follow the FDA rejection of Lykos’ midomafetamine at the end of last week. In its complete response letter to Lykos, the drug agency said it couldn’t approve the treatment based on the data submitted, according to the company. The regulator has requested that Lykos run another phase 3 trial to further weigh the efficacy and safety of MDMA-assisted therapy for PTSD.
For its part, Lykos said it plans to request a meeting to ask the FDA to reconsider the decision.