iOnctura SA | MedPath

iOnctura Initiates Phase II OCULE-01 Trial of Roginolisib for Metastatic Uveal Melanoma

2 months ago

• iOnctura has dosed the first patient in its randomized Phase II OCULE-01 study evaluating roginolisib, an allosteric PI3Kδ modulator, in patients with metastatic uveal melanoma. • The European Medicines Agency recently granted Orphan Drug Designation for roginolisib, providing 10 years of market exclusivity in the EU, complementing the FDA's ODD designation received in 2023. • In previous Phase I trials, roginolisib demonstrated excellent safety and doubled overall survival to 16 months in metastatic uveal melanoma patients compared to historical controls.