Lykos Therapeutics’ Restructuring to Advance PTSD Treatment
Lykos Therapeutics, a company at the forefront of mental healthcare innovation, has announced a significant reorganization to enhance its efforts in resubmitting the new drug application (NDA) for midomafetamine capsules, aimed at treating post-traumatic stress disorder (PTSD) in adults. This strategic move underscores Lykos’ unwavering commitment to bringing this groundbreaking therapy to market despite the challenges posed by recent FDA feedback.
Jeff George, Chairman of Lykos’ Board, emphasized the company’s dedication to addressing the FDA’s concerns and the additional work required to ensure the approval of midomafetamine. As part of the reorganization, Dr. David Hough has been appointed to lead the clinical development program and engage with the FDA. Dr. Hough brings a wealth of experience from his tenure at Johnson & Johnson, where he played a pivotal role in the development of several key psychiatric drugs, including SPRAVATO® (esketamine nasal spray). His expertise is expected to be instrumental in navigating the complex regulatory landscape and advancing midomafetamine toward approval.
In addition to leadership changes, Lykos will be reducing its workforce by approximately 75%, focusing its remaining resources on critical clinical development and regulatory engagement. CEO Amy Emerson acknowledged the pioneering efforts of the Lykos team in advancing midomafetamine through clinical trials and highlighted the importance of delivering robust clinical data to support the NDA resubmission.
To support this effort, Lykos has established an Independent Advisory Board that will provide guidance throughout the resubmission process. This board will ensure continued engagement with key stakeholders, including behavioral health facilities, the mental health community, and patient groups such as veterans and survivors of sexual violence.
Notably, Dr. Rick Doblin, Founder and President of MAPS, has resigned from the Lykos board to focus on his advocacy work following the FDA’s decision. Dr. Doblin expressed disappointment over the FDA’s stance but remains committed to advancing the global accessibility of MDMA and other psychedelics through MAPS’ multidisciplinary research and policy reform efforts. His departure marks the end of an era, but his legacy continues to inspire the ongoing work in psychedelic research and development.
Lykos’ reorganization reflects a strategic shift to ensure the successful resubmission of midomafetamine’s NDA. With Dr. Hough at the helm and a leaner, more focused team, Lykos is well-positioned to address the FDA’s requirements and ultimately bring this much-needed therapy to the millions suffering from PTSD.
