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- Lykos Therapeutics Announces Completion of European Phase 2 Study of MDMA-Assisted Therapy for Post-Traumatic Stress Disorder
The completion of the study marks an important next step in the company's European program
SAN JOSE, California, April 24, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental health care, announced the completion of a European study of Phase 2 (MP18), a multicenter, open-label feasibility study of investigational midomafetamine (MDMA) capsules, used in combination with psychological intervention ("MDMA-assisted therapy") for adults with post-traumatic stress disorder ("PTSD"). Having completed pivotal Phase 3 clinical studies in the United States, the U.S. Food and Drug Administration ("FDA") is currently reviewing the new drug application ("NDA") for Lykos' investigational midomafetamine capsules.
"Given the significant need for new treatment options for people with mental health problems in Europe, the completion of this Phase 2 study is an important step to help address unmet needs outside the United States," said Amy Emerson, CEO of Lykos Therapeutics. "By first seeking FDA approval for MDMA-assisted therapy, we believe the learnings will be beneficial as we determine our regulatory strategy in the UK and Europe. We are exploring different avenues to bring MDMA-assisted therapy to market outside of the United States".
The study included 21 participants treated at centers in the Netherlands, the United Kingdom, the Czech Republic, Germany and Norway. The study included an optional fMRI substudy assessing changes in brain activity in subjects with PTSD.
"The successful completion of this Phase 2 study in Europe is an important step in building on the body of evidence evaluating the efficacy and safety of MDMA-assisted therapy in the United States, where this new therapeutic approach is now under review by the FDA," said Eric Vermetten, professor of psychiatry at Leiden University Medical Center and principal investigator of the study. "There is an urgent need for new and effective evidence-based treatments for PTSD in Europe, where the reported prevalence of PTSD is up to 6.7%."1
On February 9, 2024, the FDA accepted the company's NDA for midomafetamine (MDMA) capsules used in combination with psychological intervention, including psychotherapy (talk therapy) and other supportive services provided by a healthcare provider. rated for people with post-traumatic stress disorder. The FDA granted priority review of the application and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024.
The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to standard applications.2 If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.
Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and effectiveness of midomafetamine for the treatment of post-traumatic stress disorder have not been established. Investigational midomafetamine is also being studied for other indications.
Lykos Therapeutics (anteriormente, MAPS PBC)
At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental health care. We are applying our decades in evidence-based research to develop investigational psychedelics to catalyze therapeutic approaches for mental health conditions. We are tirelessly exploring and reinventing novel approaches to address unmet needs in the mental health care space, with an initial focus on post-traumatic stress disorder. As PBC, we focus on making a positive impact on our people, communities and society. For more information, visit us at www.lykospbc.com and on LinkedIn, X, Instagram and Facebook.
1 Burri A, Maercker A. Differences in prevalence rates of PTSD in various European countries explained by war exposure, other trauma and cultural value orientation. BMC Res Notes. 2014;7:407. doi: 10.1186/1756-0500-7-407
2 FDA Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed January 2024.
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