Warsaw, Poland-based Molecure will enter the international stage with a Phase II trial targeting the rare lung disease pulmonary sarcoidosis later this year.

Molecure plans to enroll around 90 patients out of 20–30 sites throughout the US and Western Europe to test its lead molecule OATD-01 in pulmonary sarcoidosis, CMO Samson Fung told Clinical Trials Arena. The Phase II trial could set the stage for future OATD-01 trials in the larger markets of idiopathic pulmonary fibrosis (IPF) and nonalcoholic steatohepatitis (NASH).

Last week, Molecure announced plans to begin enrollment of the Phase II trial in the second half of 2022, though the company is yet to reveal details of the Phase II trial design.

Fung said Molecure plans to file an IND to the FDA for the Phase II trial in late April or early May and submit the European application in parallel.

OATD-01 is a chitinase inhibitor that could decrease airway inflammation. Molecure is also testing the dual arginase inhibitor OATD-02 in a Phase II trial of solid tumors (NCT05759923), which has an estimated completion date of November 2024.

Expanding beyond pulmonary sarcoidosis

Pulmonary sarcoidosis is a rare, inflammatory lung disease causing swollen tissue, called granuloma, to build up in the lungs. This can cause severe scarring in the lungs, difficulty breathing, and sometimes pulmonary hypertension.

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Given the disease mechanism, Molecure plans to position the Phase II trial as a proof-of-concept study using a disease marker as the primary endpoint. The trial will likely assess granuloma increase over 12 weeks using PET scans, Fung explained.

Both IPF and NASH are much larger markets than in pulmonary sarcoidosis, but trials in those indications would likely need to allow background therapies, Fung said. As a result, Molecure determined it was the best business decision to begin testing OATD-01 in a proof-of-concept trial for pulmonary sarcoidosis, where a placebo-controlled trial is viable, he notes.

An interim analysis is planned for around 50 patients, when the company can decide to end the study early, continue as planned, or expand up to 120 patients. The Phase II trial could complete as soon as 2025, with data available that same year.