Lykos Therapeutics Strategic Reorganization Following FDA's Decision Rejecting MDMA For PTSD Treatment

Lykos Therapeutics has announced a strategic reorganization in response to the recent FDA decision regarding its new drug application for MDMA capsules – also known as Ecstasy or Molly – intended for treating post-traumatic stress disorder (PTSD) in adults.

New Senior Medical Advisor

As the company recently reported, the restructuring includes the appointment of Dr. David Hough, a seasoned pharmaceutical industry veteran and former VP of Research and Development at Janssen, as the senior medical advisor. Dr. Hough will lead Lykos' clinical development program and oversee engagement with the FDA as the company prepares to resubmit its application for MDMA. "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," said Hough.

Significant Workforce Reduction And Realignment

In addition to bolstering its leadership, Lykos will significantly reduce its workforce by approximately 75%, streamlining the organization to focus on clinical development and regulatory efforts. This downsizing is part of a broader strategy to realign resources and ensure the company can efficiently address the FDA's concerns and continue the development of its MDMA-assisted therapy for PTSD.

Focus On MDMA Resubmission To FDA

"The team at Lykos has been part of a pioneering effort to bring forward the first clinical trials for midomafetamine [MDMA], and we are sincerely grateful for their contributions,” stated Lykos CEO Amy Emerson. “As we prepare to address the FDA decision, we need to focus on delivering the FDA the robust clinical data necessary to support the approval of this potential new treatment."

Rick Doblin Steps Down From Lykos Board

As part of the reorganization, Dr. Rick Doblin, founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), will leave his position on the Lykos board. Doblin expressed his disappointment with the FDA’s decision but emphasized his continued commitment to advancing the use of psychedelics in mental health treatment through MAPS. "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," Doblin said.

Jeff George, chairman of the Lykos’ board, praised Doblin’s contributions. "Rick Doblin has been a trailblazing pioneer in this field. His many decades of leadership, unparalleled dedication, and deep contributions have shaped and guided the revival of psychedelic research and development, spurring transformative innovation in mental health."

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