Parkinson: Oncodesign Precision Medicine targets IND filing for OPM-201 in early 2027
Six months after the launch of the LARKIN program, Oncodesign Precision Medicine (OPM) reported, in a press release published on October 7, 2026, a progress update on the development of OPM-201, its LRRK2 kinase inhibitor intended for the treatment of Parkinson's disease. The Michael J. Fox Foundation, which finances the program through its Therapeutic Pipeline Program, made a second payment on August 27, 2026 corresponding to the achievement of planned milestones. According to CEO Philippe Genne, the program remains "in line with its budget".
First tablets manufactured and toxicology plan validated by the EMA
On the industrial side, micronization of the active substance of OPM-201 is complete. Feasibility batches, followed by technical batches of active and placebo tablets, were manufactured with the Contract Development and Manufacturing Organization (CDMO) selected by OPM, meeting the quality criteria assessed during their production. A quality audit of this service provider was also conducted, allowing continuation of the transfer of analytical methods and preparation for GMP-compliant manufacturing of tablets intended for the phase 1b study. On the regulatory front, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) validated on July 23, 2026 the long-term toxicology study plan proposed by OPM, following a request for scientific advice submitted in April 2026. A service provider was selected to conduct this GLP regulatory study, with the main phase scheduled to begin in the first half of 2027. A comparative study of OPM-201 metabolism in human hepatocytes and various preclinical species was also finalized, in support of the toxicological strategy.
Pre-IND meeting in preparation, IND filing planned for early 2027
Clinical preparation is based on pharmacokinetic and pharmacodynamic modeling currently underway, conducted using data from the phase 1 study conducted in healthy volunteers. According to the press release, this phase 1 showed good tolerability, with no serious adverse effects observed, and engagement of the LRRK2 target in volunteers who received the highest dose. The modeling aims to optimize dose selection and dosing schedule for the next study. This work is intended to inform discussions with the American Food and Drug Administration (FDA): OPM is preparing a request for a pre-IND meeting on the dosing strategy and mode of administration for phase 1b, and submission of the IND dossier is planned for early 2027. The phase 1b study will involve people with early-stage Parkinson's disease, with a focus on carriers of a LRRK2 gene mutation. OPM acquired full rights to the program from Servier in December 2024. The company, based in Dijon, has 14 employees.
