Molecure raises $12M and gets FDA clearance for pulmonary sarcoidosis trial
Summary
Molecure S.A. has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application to conduct phase II clinical testing of OATD-01.The announcement follows the company closing a secondary public offering and entering into subscription agreements for all 2,776,000 H-shares offered by way of private placement, within the authorized capital. As we have confirmed in a range of preclinical studies, OATD-01 has the ability to modulate macrophage activity, meaning it has the potential to be disease modifying and treat various inflammatory and fibrotic diseases which develop based on a similar molecular mechanism.In the coming weeks we are also planning to file for approval of phase II clinical trials with the European Medicines Agency (EMA). We expect to conclude these phase II clinical studies in mid-2025 with the publication of a report analyzing the headline data, said Marcin Szumowski, CEO of Molecure.In recent months weve put a lot of effort into raising the profile of our clinical research plans with OATD-01 internationally a process designed to build relationships with renowned clinical experts who specialize in lung diseases (including sarcoidosis), as well as foundations and other organizations which build communities to support patients suffering from a range of difficult diseases that have a significant and negative impact on the quality of their lives.OATD-01 has displayed disease-modifying abilities in preclinical trials and has the potential to become the new standard of care for treating pulmonary sarcoidosis.The phase II clinical trial of OATD-01 is expected to be a multi-center, randomized, double-blind, placebo-controlled study assessing the drugs safety and effectiveness in treating approximately 90 pulmonary sarcoidosis patients. This endpoint was agreed with the FDA following a pre-IND meeting.OATD-01, is an oral, once-daily, first-in-class highly selective CHIT1 inhibitor for the treatment of sarcoidosis. Pulmonary fibrosis results in the majority of deaths related to sarcoidosis in western countries.The proceeds raised through the offering will co-finance the implementation of the companys strategic plans for 2023 to 2025, particularly the clinical development of its two flagship programmes, namely OATD-01 and OATD-02 (a first-in-class dual arginase inhibitor for cancer).Additionally, efforts will be intensified in a portfolio of early-stage programs, including breakthrough small-molecule drug technology that modulates mRNA translation and therapeutics targeting previously unexplored protein targets.