Lykos Therapeutics, a company dedicated to transforming mental healthcare, is reorganizing 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.
 
This reorganization is happening in response to the FDA’s recently issued complete response letter (CRL) for the NDA for midomafetamine capsules for the treatment of PTSD in adults. The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date. The FDA requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine.
 
“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.”

Dr. David Hough Appointed Senior Medical Advisor

As part of the changes, Dr. David Hough will lead and oversee the clinical development program and FDA engagement regarding the resubmission of midomafetamine.
 
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 Jeff 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).”

Workforce Reduction

In addition, the company will reduce 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, CEO 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.”
 
Read more about biopharma industry layoffs.
 
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.”