OPM announces positive interim results from its phase 1 study evaluating OPM-101 in healthy volunteers








(Boursier.com) — Oncodesign Precision Medicine, a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, announces positive interim results at the end of the first part of the phase 1 trial in single oral administration at increasing doses (SAD) of its drug candidate OPM-101 in healthy volunteers.

Jan Hoflack, Deputy Managing Director and Chief Scientific Officer of Oncodesign Precision Medicine, said: “OPM-101 was very well tolerated and showed significant target engagement over a 24-hour period, starting at low doses. . These arguments are in favor of a profile with a significant therapeutic margin. The data review committee (DRC) reviewed and analyzed all the data obtained during the SAD part of the study, and recommended the start of the MAD (repeated administrations) part of the study. In this part, the administration of OPM-101 will be done twice daily at doses allowing to maintain target engagement greater than 80%. Start-up of the MAD part is planned for early Q4-2023. The execution of this Phase 1 SAD – 9 cohorts in just 7 months – demonstrates the quality of our OPM-101 product and that of our preclinical and clinical teams.”

Philippe GENNE, Chairman and CEO of Oncodesign Precision Medicine, adds: “We are very satisfied with the progress of this clinical trial at this stage. OPM-101 is a molecule which has an ideal pharmacological profile, it is a drug candidate perfect which will fully allow us to test the therapeutic potential of RIPK2 kinase inhibition in the context of chronic inflammatory digestive diseases in patients. These results strengthen our lead over our main competitors identified to date and are very attractive with regard to with the main global key opinion leaders with whom we are working to build the phase 2 clinical trial.”


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