Molecure - OATD-01 gearing up for Phase II
Molecure has filed an Investigational New Drug (IND) application with the US FDA for OATD-01. Clearance of the application will enable the company to initiate a global (US and EU), multi-centre, randomised, double-blind, placebo-controlled Phase II study (expected n=90) to assess the safety and efficacy of OATD-01 in patients with pulmonary sarcoidosis. Management anticipates that the trial will commence in Q423. Results from this double-blind study will be shared once it has been completed, expected to be in H125. We view the filing of this IND application as a key milestone for Molecure, and believe that the results from the trial will be an important catalyst for investor attention.OncoArendi Therapeutics SA (OAT) is a Poland-based biopharmaceutical company dedicated to discovering, developing and commercializing therapeutics for neoplastic and inflammatory diseases. The Companys business model is strictly focused on drug discovery and development, with its core strength in medicinal chemistry and preclinical biology, enhanced by scientific collaborations with the key opinion leaders in specific disease areas.
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