Lykos, MAPS Cut Staff As New Leadership Takes Charge of MDMA-AT Research
After the rejection of its New Drug Application for MDMA-assisted therapy to treat PTSD, Lykos Therapeutics announced a major reorganization on Thursday, cutting its workforce by 75% and appointing new leadership. The company, which reportedly laid off about 100 employees, will prioritize “clinical development and regulatory engagement,” towards the resubmission of its New Drug Application (NDA) for MDMA-AT. The MAPS nonprofit organization, Lykos’s largest single shareholder, has also cut 33% of its workforce.
Dr. David Hough, a former U.S. Army officer and psychologist, led the team that secured FDA approval for the eskatamine nasal spray Spravato. Hough was appointed to oversee Lykos’ resubmission process as its new senior medical advisor. Lykos also announced that Rick Doblin, the founder and president of MAPS, who initiated the development of the MDMA-AT clinical trials, will step down from its board of directors.
The restructuring comes less than a week after the FDA rejected the Lykos MDMA-AT proposal and requested additional Phase 3 trials, a ruling the company said it will ask the agency to reconsider. “We take to heart the FDA’s decision and the additional work we will need to do to bring this pioneering therapy to market,” said Lykos chairman Jeff George.
The MAPS nonprofit, and Lykos, which is the successor organization to the for profit MAPS Public Benefit Corporation, will now pursue different paths with distinctly separate styles.
A Consummate Industry Professional
As senior medical advisor, Hough will oversee Lykos’s clinical development program and lead engagement with the FDA. Hough was Vice President of Research and Development at J&J Innovative Medicine, where he served in various leadership roles for more than 17 years, including overseeing “all medical, scientific, manufacturing, quality, preclinical, and commercial aspects” of the Spravato program.
Prior to his career in the pharmaceutical industry, Hough was an officer and psychiatrist in the U.S. Army with more than a decade of military medical service. He has overseen behavioral health departments at military hospitals, trained psychiatry residents, and served as the director of outpatient clinics. Hough’s military background is in sync with a key group of supporters. Veterans organizations and their allies in Congress were among the most prominent and persuasive voices advocating for the approval of MDMA-AT for PTSD.
“Dr. Hough is a consummate industry professional and exactly the right person to lead the crucial work of engaging with the FDA for our resubmission,” said George. “His experience in recent approvals, including Spravato, is greatly relevant to our organization’s mission.” George said that together, Hough and the remaining Lykos team will be “focused on its ongoing clinical development, medical affairs, and engagement with the FDA.”
In a statement issued on Thursday, Hough said, “My hope is to build on the strong foundation Lykos has created and leverage my experience in the industry to ensure a productive ongoing dialogue with the FDA and oversee the clinical work that needs to be done to address the Agency’s questions which will allow us to serve patients safely and effectively.”
Doblin Out At Lykos As Phase 2 Research Is Retracted
Rick Doblin, the founder and president of the MAPS nonprofit organization, departed the Lykos board of directors, vacating one of the six board seats that the nonprofit organization gets to appoint as the drug company’s largest single shareholder.
“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,” said Doblin.
George acknowledged Doblin as “a trailblazing pioneer in this field” whose “decades of leadership, unparalleled dedication, and deep contributions have shaped and guided the revival of psychedelic research and development.” That research has come under renewed scrutiny in light of the FDA’s decision.
Last weekend, the journal Psychopharmacology retracted three articles that had been previously published, citing undisclosed “protocol violations amounting to unethical conduct” at a Phase 2 trial site in Canada. This conduct included the sexual abuse of a participant by an unlicensed therapist participating in the trial. Doblin and Lykos CEO Amy Emerson were listed as authors on two of the three retracted studies, which were not used to support the Lykos NDA.
Psychopharmacology said in a statement that, “The authors have subsequently confirmed that they were aware of these violations at the time of submission of this article, but did not disclose this information to the journal or remove data generated by this site from their analysis.” In a statement, Lykos expressed its disagreement with the retractions and belief that the “identified issues should have been addressed through corrections,” which it said “was initially requested by the journal.”
Lykos said “the articles remain scientifically sound and present contributions to the study of potential treatments for PTSD.” The company also acknowledged that it reported the ethical violations at issue to authorities in Canada and the U.S. and issued a public statement, but did not disclose them to the journal itself, “an additional step we should have taken and regret not doing.”
Psychopharmacology also charged that the authors failed to fully declare conflicts of interest, noting that several authors are affiliated with MAPS and its then subsidiary, MAPS PBC, which became Lykos earlier this year. Lykos disputes this charge. The company has filed a formal complaint with the Committee on Publication Ethics (COPE), arguing that the issues should have been resolved through corrections rather than retractions.
MAPS Cuts Staff As Doblin Seeks To Speak More Freely
In light of “external events [that] have further exacerbated an already challenging fundraising climate,” Vicky Dulai, chair of the MAPS nonprofit board of directors said today that the organization “made the difficult decision to reduce our staff by 33%,” cutting 14 positions from the 43 person staff.
Dulai said, “Our organization was staffed for a different outcome from the FDA, and now we must consider which of our programs will best support creating access to safe, legal, equitable psychedelic-assisted therapies for people who are suffering.”
Doblin says he is leaving the Lykos board “to be free to advocate for a complex agenda” at MAPS. “My activist voice and vision are needed now more than ever at MAPS and in our broader community,” Doblin said in a statement released by the nonprofit today. Doblin says he intends to “refocus on public education, policy reform, and global research into MDMA-assisted therapy for PTSD in places with high burdens of trauma and inadequate access to resources, couples therapy research, and more.” Doblin also seeks to develop “public benefit metrics to hold psychedelic companies like Lykos accountable for their public benefit mission.”
“For several years, I have been heavily constrained in my ability to speak freely,” said Doblin who has been outspoken for decades about drug policy issues. “The Lykos and MAPS Boards feared that, as a member of the Lykos Board, my activist voice could be interpreted to violate my fiduciary responsibilities or result in compliance issues within the heavily regulated pharmaceutical industry.”
As its president, Doblin continues to hold a fiduciary responsibility to the MAPS nonprofit, which will maintain its stake in Lykos. In a statement provided to Lucid News, Betty Aldworth, director of communications and post-prohibition strategy for MAPS confirmed that “the MAPS board will appoint a replacement” for the seat vacated by Doblin. Dulai said, “We will continue to support Lykos in its pursuit of FDA approval.” `
“Now is a time for a clear-headed analysis of where we fell short and how we can do better moving forward,” Doblin said. “It is a time for us to recalibrate our strategy, rebuild trust with our stakeholders, and draw strength from our spiritual audacity to continue to build the future we know is possible.”
Lykos Suits Up For The Rebound
Lykos is pursuing a more mainstream approach by recruiting advisors with experience navigating the regulatory process. The appointment of Hough as senior medical advisor is the latest illustration of this realignment. This follows the creation of an independent Lykos advisory board that was announced prior to the FDA decision. That board, which was named as part of new oversight initiatives, is comprised of “external experts in corporate and medical ethics, innovation, psychiatry, and military and veteran health,” who will now be coordinated by Hough and the Lykos management team. The company’s strategy will now focus on opportunities to negotiate with the FDA.
The Lykos advisory board will provide “overall support and guidance to the management team throughout the resubmission process,” Lykos said. The company is also relying on this body to “ensure continued engagement with top-tier behavioral health facilities, the mental health community, and key patient stakeholder groups such as veterans and survivors of sexual violence.”
Lykos CEO Amy Emerson spelled out the mission: “We need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential new treatment.”