Poland-based Molecure has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) before starting a Phase II trial to evaluate its Chitotriosidase (CHIT1) inhibitor (OATD-01) in pulmonary sarcoidosis.

The company expects to begin trial enrolment in the fourth quarter of 2023 across multiple sites in the US and Europe.

Pulmonary sarcoidosis is a rare inflammatory disease of unknown etiology that causes small inflammatory lumps in the lungs. This can cause lung scarring (fibrosis), resulting in difficulty breathing. The treatment is usually symptomatic with steroids to reduce inflammation.

OATD-01 is a selective CHIT1 inhibitor that produces an anti-inflammatory effect and can reduce fibrosis.

Molecure CEO Marcin Szumowski justified the potential of OATD-01 for becoming the first-line treatment, stating: “There are currently no approved therapies for sarcoidosis, and while steroids are often used, they have serious side effects and deliver only short-term benefits with little evidence of extended therapeutic efficacy.”

According to the company, the Phase II trial will be randomised, multicentre, and placebo-controlled, with results expected in the first half of 2025. The primary endpoint would be a reduction in inflammation at 12 weeks.

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By GlobalData

As per GlobalData’s analysis, although the number of clinical trials for sarcoidosis has increased over the last decade, the preference for generic drugs limits market growth.

GlobalData is the parent company of Clinical Trials Arena. 

A Phase II trial (NCT05314517) evaluating namilumab in pulmonary sarcoidosis by Kinevant Sciences is currently underway, with expected trial completion in May 2024.

OATD-01 has an orphan drug designation (ODD) from the US FDA for sarcoidosis and idiopathic pulmonary fibrosis.

Molecure’s OATD-02, a dual arginase inhibitor, for solid tumours is currently in Phase II (NCT05759923), with an estimated trial completion in November 2024.