Galapagos has posted on CT.gov (https://clinicaltrials.gov/ct2/show/NCT04971746) the start of a clinical trial with GLPG4716 (OATD-01) to evaluate potential pharmacokinetic drug-drug interactions with pirfenidone and nintedanib, which are drugs that are approved and standard of care for treatment of idiopathic pulmonary fibrosis (IPF). Since in a future phase 2 trial in IPF patients GLPG4716 (OATD-01) would have to be given on top of standard of care, it is important to investigate at what doses GLPG4716 can be combined with these drugs.
After signing in November 2020 an exclusive cooperation agreement and license agreement for the global development and commercialization of OATD-01 between Galapagos NV and OncoArendi Therapeutics S.A., the Belgian partner decided on the next steps in the development of the molecule. GLPG4716 (OATD-01) is an inhibitor of chitotriosidase and acidic mammalian chitinase (CHIT1/AMCase), ready to start phase 2, for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrosis diseases.
Idiopathic pulmonary fibrosis (IPF) is a rare disease. The estimated number of IPF patients worldwide varies greatly from less than 200,000 diagnosed cases in the 7 major markets to as many as 3 million globally. It can be assumed that the market demand for a new drug is about 500 thousand worldwide. After diagnosis, the patient with IPF survives an average of 3-5 years. Often, lung cancer develops in IPF patients. In the treatment of IPF, 2 drugs are currently approved, which have severe restrictions on use due to significant side effects.