Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, today announced a reorganization to best support the company as it works to address the resubmission of its new drug application ("NDA") for midomafetamine capsules for the treatment of post-traumatic stress disorder ("PTSD") in adults.

"Lykos is deeply dedicated to bringing midomafetamine to those suffering from PTSD and remains highly committed to this goal," said Jeff George, Chairman of the Lykos Board. "At the same time, we take to heart the FDA's decision and the additional work we will need to do to bring this pioneering therapy to market."

As part of the changes, Dr. David Hough will lead and oversee the clinical development program and FDA engagement regarding the resubmission of midomafetamine. Dr. Hough previously was Vice President of Research and Development at J&J Innovative Medicine (a Johnson & Johnson company). He served in various leadership roles over 17 years, including as the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, INVEGA TRINZA, as well as the compound development team leader for SPRAVATO^® (esketamine nasal spray), a position in which he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program.

"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," said Dr. Hough.

"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," added Mr. George. "His experience in recent approvals, including SPRAVATO^®, is greatly relevant to our organization's mission. We are grateful that he will join our team and we look forward to engaging the FDA in the coming months to work to bring this therapy to the millions of those suffering from post-traumatic stress disorder (PTSD)."

In addition, the company will be reducing its workforce by approximately 75%, with the remaining team focused on its ongoing clinical development, medical affairs, and engagement with the FDA. 

"The team at Lykos has been part of a pioneering effort to bring forward the first clinical trials for midomafetamine and we are sincerely grateful for their efforts," said Amy Emerson, Chief Executive Officer of Lykos. "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."

Lykos' newly formed Independent Advisory Board will also provide overall support and guidance to the management team throughout the resubmission process and 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.

In addition, Dr. Rick Doblin, the Founder and President of MAPS, has left his position on the Lykos board.

"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 Dr. Doblin. "I can speak more freely as a public advocate by resigning from the Lykos Board. The FDA delays make it more important than ever that I work at MAPS toward developing global legal access to MDMA and other psychedelics for public benefit through MAPS' multidisciplinary research, education, and drug policy reform."

"Rick Doblin has been a trailblazing pioneer in this field," said Mr. George. "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. His legacy will continue through the work of both Lykos and its peers as we all work towards providing new and better treatment options for millions of patients in need."

Dr. Hough is a graduate of West Point and served for several years as an Army officer before attending medical school at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. After completing residency training in Psychiatry at Walter Reed Medical Center in Washington DC, he served for 10 years as an Army psychiatrist at two separate community hospitals and on faculty at a psychiatry residency program in Honolulu, Hawaii. He supervised numerous psychiatry residents and allied mental health professionals serving as head of outpatient clinics and behavioral health departments in different military hospitals. He completed a two-year research fellowship in Clinical Pharmacology jointly sponsored by USUHS and Walter Reed Army Institute of Research. He is board certified in both Adult and Geriatric Psychiatry and held an Adjunct Assistant Professor of Psychiatry position at USUHS for several years. He has authored numerous publications in peer reviewed journals, is a reviewer for several journals, and was an examiner for the American Board of Psychiatry and Neurology. He served in various leadership roles over 17 years at J&J Innovative Medicine including as the compound development team leader for INVEGA (paliperidone), INVEGA SUSTENNA, INVEGA TRINZA, as well as the compound development team leader for SPRAVATO^® (esketamine nasal spray), a position in which he was responsible for all medical, scientific, manufacturing, quality, preclinical, and commercial aspects of the program.

Midomafetamine capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD. Investigational midomafetamine is also being studied in other indications.