Simbec-Orion to conduct a Phase II clinical trial in pulmonary sarcoidosis patients for Molecure’s OATD-01

Warsaw, 3rd July 2023

Molecure has signed an agreement to conduct a Phase II clinical trial for its lead molecule OATD-01, taking another important step in the development of this program.

  • The agreement with Simbec-Orion includes organizing and fully executing a proof-of-concept Phase II clinical trial in patients with pulmonary sarcoidosis.
  • The Phase II proof-of-concept study of OATD-01 will be conducted as multi-center and international clinical trial in the United States and the European Union and is expected to start in Q4 2023.
  • OATD-01 is a first-in-class chitotriosidase 1 (CHIT1) inhibitor that modulates macrophage function and has broad therapeutic potential for the treatment of inflammatory and fibrotic diseases.
  • Molecure has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a Phase II study in the United States.
  • Molecure has received Orphan Drug Designation (ODD) from the FDA for OATD-01 in sarcoidosis and idiopathic pulmonary fibrosis.

Read the full press release here

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