Lykos Therapeutics Reorganizes in Response to FDA Decision on PTSD Drug

Lykos Therapeutics, a company focused on revolutionizing mental healthcare, has announced a significant restructuring to better support its efforts in resubmitting its new drug application (NDA) for midomafetamine capsules, aimed at treating post-traumatic stress disorder (PTSD) in adults. Dr. David Hough, a seasoned pharmaceutical executive and former Vice President of Research and Development at J&J Innovative Medicine, has been appointed as the senior medical advisor to lead clinical and regulatory engagements with the FDA.

In his previous role, Dr. Hough led the development of several key compounds, including INVEGA (paliperidone) and SPRAVATO® (esketamine nasal spray). He brings a wealth of experience in medical, scientific, manufacturing, quality, preclinical, and commercial aspects of pharmaceutical development. "My goal is to build on Lykos' strong foundation and ensure productive dialogue with the FDA," said Dr. Hough, emphasizing his commitment to resolving the Agency's concerns to safely and effectively serve patients.

Jeff George, Chairman of the Lykos Board, expressed confidence in Dr. Hough's capabilities, citing his relevant experience in recent approvals, particularly with SPRAVATO®. George also thanked Dr. Hough for joining the team, highlighting the importance of this move for millions suffering from PTSD.

In addition to leadership changes, Lykos will reduce its workforce by approximately 75%. The remaining team will focus on clinical development, medical affairs, and FDA engagement. Amy Emerson, CEO of Lykos, expressed gratitude for the team's pioneering efforts in bringing forward the first clinical trials for midomafetamine. She emphasized the need to deliver robust clinical data to support the FDA's approval process for this new treatment.

The restructured organization will also benefit from the guidance of a newly formed Independent Advisory Board. This board will support the management team throughout the resubmission process, ensuring continued engagement with top-tier behavioral health facilities and key patient stakeholder groups, including veterans and survivors of sexual violence.

In another significant development, Dr. Rick Doblin, the founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), has resigned from his position on the Lykos Board. Dr. Doblin expressed both disappointment and optimism about the FDA's decision, stating that the organization will continue its clinical research to address the FDA's questions. He plans to focus on advocating for global legal access to MDMA and other psychedelics through MAPS' multidisciplinary research, education, and drug policy reform.

Jeff George acknowledged Dr. Doblin's pioneering contributions to the field of psychedelic research and development, noting that his legacy will continue through the work of Lykos and its peers. Dr. Doblin has been instrumental in reviving psychedelic research, spurring transformative innovations in mental health.

Dr. David Hough's background includes a notable military career, with service as an Army officer and psychiatrist. He completed his medical education at the Uniformed Services University of the Health Sciences (USUHS) and residency in Psychiatry at Walter Reed Medical Center. Over 17 years at J&J Innovative Medicine, he led the development of several key compounds and held various leadership roles. Dr. Hough is board-certified in both Adult and Geriatric Psychiatry and has an extensive list of publications and contributions to the field.

Midomafetamine capsules, while showing promise, have not yet been approved by any regulatory agency. Their safety and efficacy for treating PTSD remain under investigation.

PTSD is a severe mental health condition that affects around 13 million Americans annually. It's more prevalent among women, marginalized communities, and military personnel. The condition results in debilitating symptoms such as nightmares, intrusive thoughts, avoidant behaviors, and hyperarousal, impacting nearly all aspects of life. PTSD is often chronic, with significant personal and economic costs.

Current PTSD treatments include trauma-focused talk therapy and two approved SSRIs, sertraline and paroxetine. However, these treatments have limitations, including high dropout rates and lingering symptoms. This underscores the urgent need for new evidence-based therapies.

Lykos Therapeutics is pioneering the development of midomafetamine-assisted therapy, building on decades of research into MDMA's potential to support psychotherapy. Lykos aims to transform mental healthcare by developing innovative psychedelic therapies for mental health conditions, with an initial focus on PTSD. The company continues to explore novel approaches to address unmet needs in mental healthcare.

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