Phase I trial set to start to evaluate novel asthma treatment

A Phase I study is set to be initiated by OncoArendi Therapeutics to assess the safety, tolerability and pharmacokinetics of its lead compound and novel drug candidate, OATD-01 for the treatment of asthma.

The innovative biopharmaceutical company has been granted permission from the German Federal Institute for Drugs and Medical Devices (BfArM) to begin the first-in-human clinical evaluation of the therapy. OATD-01 is a dual inhibitor of acidic mammalian chitinase (AMCase) and chitotriosidase (CHIT1), that was developed as an oral therapy to treat asthma. It is the first drug candidate of its kind to enter clinical development and data from this Phase I study will be used to guide the design of the subsequent trial, which will assess dosage.

“The initiation of the Phase I clinical trial of OATD-01 is a major milestone, not only for the programme, but also for the advancement of an entirely new class of drugs. It is also a significant milestone in the development of OncoArendi as it has now become a clinical-stage biotechnology company,” said Marcin Szumowski, OncoArendi’s president and CEO.

“Our first dosing of OATD-01 represents the culmination of years of chemistry and biology discovery as well as chemical and preclinical development work. With the recent discovery of the significant anti-fibrotic activity of OATD-01 we are very excited about the clinical prospects of the chitinase inhibitors in treatment of not only asthma but also other interstitial lung diseases including idiopathic pulmonary fibrosis or sarcoidosis,” added Stanislaw Pikul, VP of Development.