European Phase 2 MDMA-Assisted PTSD Therapy Study Concludes

Lykos Therapeutics, a firm at the forefront of mental healthcare innovation, has announced the successful conclusion of a Phase 2 clinical trial in Europe. The study, known as MP18, was designed to assess the feasibility of using midomafetamine (MDMA) capsules in conjunction with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. This open-label, multicenter trial is a significant milestone in the company's European expansion efforts.

The trial, which involved 21 participants across various European countries including the Netherlands, the UK, Czech Republic, Germany, and Norway, also featured an optional functional magnetic resonance imaging (fMRI) sub-study to measure changes in brain activity among PTSD sufferers. The lead investigator, Eric Vermetten, a psychiatry professor at Leiden University Medical Center, highlighted the urgency for innovative and effective treatments for PTSD, noting that the prevalence of the disorder in Europe can reach up to 6.7%.

Amy Emerson, CEO of Lykos Therapeutics, emphasized the importance of this study in addressing the significant demand for new mental health treatments in Europe. She expressed the company's strategy to leverage the FDA approval process for MDMA-assisted therapy as a precursor to shaping their regulatory approach in the UK and Europe. Lykos is currently exploring multiple paths to make this therapy available in international markets.

The FDA has already acknowledged the company's new drug application for midomafetamine capsules, which are being considered for use alongside psychological intervention, including psychotherapy and other supportive care for PTSD patients. The application has been granted Priority Review by the FDA, indicating that if approved, the therapy could offer substantial improvements over existing treatments for serious conditions. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for August 11, 2024.

It is important to note that midomafetamine has not yet received regulatory approval from any agency, and its safety and efficacy for PTSD treatment are still under evaluation. The company is also researching midomafetamine for other potential uses.

Lykos Therapeutics, originally known as MAPS Public Benefit Corporation, is a public benefit corporation founded with the aim of revolutionizing mental health treatment. The company is committed to developing new psychedelic-based therapies for mental health conditions, starting with PTSD, and is dedicated to creating a positive impact on individuals, communities, and society at large.

The completion of the Phase 2 study in Europe is a testament to Lykos Therapeutics' ongoing commitment to advancing mental health treatment options and signifies a promising step towards providing much-needed relief for those suffering from PTSD.