Company continues to distance itself from MAPS as it forges a new path forward following FDA setback.
Lykos Therapeutics said Sept. 6 CEO Amy Emerson will step down, marking another significant shift away from its MAPS roots.
Emerson, who started as a consultant with MAPS, the Multidisciplinary Association for Psychedelic Studies, in 2003 will transition to a senior advisory role within the company.
This follows the earlier departure of MAPS founder Rick Doblin from the board of directors.
Michael Mullette, who has served as chief operating officer since early 2022, will assume the role of interim CEO.
Lykos Chairman Jeff George expressed confidence in Mullette’s leadership, citing his “deep understanding of the path ahead” and “impressive track record from over two decades in pharmaceuticals.”
Mullette ran Moderna’s North American operations during the COVID-19 vaccine rollout and worked for nearly two decades with Sanofi in various global leadership roles.
In addition to Mullette’s appointment, Lykos announced that Dr. David Hough, recently brought on as senior medical advisor, will now serve as chief medical officer.
Hough worked in various roles at Johnson & Johnson for 17 years.
The leadership shakeup comes in the wake of the FDA’s rejection of Lykos’ bid to approve MDMA for the treatment of post-traumatic stress disorder (PTSD) in adults. The FDA cited concerns including alleged misconduct by trial therapists, expectation bias and lack of true double-blinding in studies.
MAPS formed Lykos Therapeutics, formerly MAPS Public Benefit Company, to develop investigational midomafetamine (MDMA) capsules in combination with psychological intervention in adults with post-traumatic stress disorder (PTSD).
Despite the FDA setback, Lykos has stated its intention to proceed with another Phase 3 trial for MDMA-assisted therapy in PTSD.
“Charting a path toward FDA approval will require seasoned leadership and expertise,” said Suprotik (Protik) Basu, Lykos board director and managing partner at Helena, Lykos’s lead investor. “I’ve gotten to know both Mike and Dave over the past year, and I have deep conviction in their ability and commitment to bringing this treatment, if approved, to the millions who are waiting with great hope.”