Oncodesign Precision Medicine announced several manufacturing, regulatory, and development milestones for OPM-201, its LRRK2 kinase inhibitor being developed for Parkinson’s disease.
The progress was achieved through the LARKIN program, which is supported by The Michael J. Fox Foundation for Parkinson’s Research through its Therapeutic Pipeline Program.
The foundation has released an additional funding tranche following achievement of milestones under the program.
OPM completed micronization of the OPM-201 active pharmaceutical ingredient and successfully manufactured feasibility and technical batches of active and placebo tablets.
The company’s contract development and manufacturing organization also completed its quality audit.
OPM can now proceed with analytical method transfers and preparation for GMP manufacturing of tablets intended for a future Phase 1b clinical study.
The company also received support from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed long-term toxicology strategy.
The CHMP provided the scientific advice on July 23, 2026.
A contract research organization has been selected for the GLP toxicology study, with the main phase expected to begin during the first half of 2027.
OPM is also conducting pharmacokinetic and pharmacodynamic modeling using results from its Phase 1 study in healthy volunteers.
The work will support dose selection and preparation for discussions with the U.S. Food and Drug Administration.
OPM plans to request a pre-IND meeting and currently expects an IND submission in early 2027.
The company’s objective is to begin a Phase 1b study in Parkinson’s disease patients in 2027.
KEY QUOTES:
“Six months after the launch of the LARKIN program with the support of The Michael J. Fox Foundation, we have achieved several key milestones in the development of OPM-201. Our objective is now to maintain this momentum as we prepare for the evaluation of OPM-201 in patients with Parkinson’s disease in 2027.”
Philippe Genne, Co-Founder, President and Chief Executive Officer of Oncodesign Precision Medicine
“The progress achieved over the past six months strengthens our confidence in the development path of OPM-201. The manufacturing of the first technical batches, together with the CHMP’s scientific advice on our long-term toxicology strategy, represent important milestones in supporting the continued development of the candidate.”
Dr. Jan Hoflack, Co-Founder and Chief Scientific Officer of Oncodesign Precision Medicine
