Lykos Therapeutics Reshuffles Board of Directors Following FDA Rejection of Midomafetamine Capsules

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Lykos Therapeutics revealed significant changes to its board of directors as it prepares for the resubmission of a new drug application (NDA) for midomafetamine capsules for the treatment of post-traumatic stress disorder (PTSD) and secures financing to support its strategic goals. According to the company, independent directors Jeff George, Scott Giacobello, and Jason Pyle, MD, PhD, will be stepping down along with Kris Lotlikar, a board member designated by the Multidisciplinary Association for Psychedelic Studies (MAPS).¹

“The outgoing members of the Lykos board, and in particular board chair Jeff George, provided strong governance, leadership and support for this company as it has navigated the challenge of bringing forward a pioneering treatment. The company is indebted to each of them for the expertise, sound judgement and tireless effort they provided,” said Mike Mullette, interim CEO, Lykos Therapeutics, in a press release. “In addition, I am pleased to welcome Lykos’ new members to the board, and I look forward to their collaboration as we move forward with the company’s important work.”

To replace the departing board members, MAPS has appointed Ron Beller and Joe Green. Additionally, Joseph McCowan, PsyD, will join the board as a replacement for Gisselle Acevedo, Med, JD, LMFT, who stepped down from her role last month. Dan Grossman, PhD, who previously held a board seat, will remain as an independent director.¹

In August 2024, the FDA issued a Complete Response Letter (CRL) to Lykos for the NDA seeking approval of midomafetamine capsules for PTSD. In a press release, the company stated that the current data was insufficient to support an approval and requested an additional Phase III trial that includes extensive measures to minimize bias.

In response to the CRL, MAPS announced its intentions to plan out a successful path towards safe, legal access to MDMA-assisted therapy, with plans to advance research that helps to provide new investigative directions, enhance patient access and experience, and provide data-driven drug policy and education. MAPS also intends to advocate for policy changes that support public health.^2,3

"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Amy Emerson, CEO, Lykos Therapeutics, in a press release. "While conducting another Phase III study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."

According to the American Psychiatric Association, PTSD affects an estimated 3.5% of adults in the United States annually. Additionally, the lifetime prevalence of PTSD in adolescents is an estimated 8%. Latinos, African Americans, and Native Americans/Alaska Natives have higher rates of PTSD than white Americans.⁴

The National Center for PTSD states that most people who experience a traumatic event will not experience PTSD. An estimated 6% of people in the United States will experience the condition at some point during their lifetime. Statistics also show that women and veterans are more likely to experience PTSD.⁵

As part of the transition period, Lykos stated that it is working with multiple shareholders, such as MAPS and Helena, as well as several new investors, to align on a financing strategy.¹

References

1. Lykos Therapeutics Announces Changes to its Board of Directors. Lykos. January 14, 2025. Accessed January 15, 2025. https://news.lykospbc.com/2025-01-14-Lykos-Therapeutics-Announces-Changes-to-its-Board-of-Directors

2. FDA Issues Complete Response Letter to Lykos Therapeutics for Midomafetamine Capsules in the Treatment of Post-Traumatic Stress Disorder. PharmExec. August 12, 2024. Accessed January 15, 2025. https://www.pharmexec.com/view/fda-issues-complete-response-letter-lykos-therapeutics-midomafetamine-capsules-treatment-post-traumatic-stress-disorder

3. Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD. Lykos. August 9, 2024. Accessed January 15, 2025. https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD

4. What is Posttraumatic Stress Disorder (PTSD)? APA. Accessed January 15, 2025. https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd#:~:text=PTSD%20affects%20approximately%203.5%20percent,as%20men%20to%20have%20PTSD.

5. PTSD: National Center for PTSD. VA. Accessed January 15, 2025. https://www.ptsd.va.gov/understand/common/common_adults.asp