Germany’s top regulatory agency has approved a Phase 1 clinical study in healthy volunteers of OATD-01, an investigative asthma drug developed by Poland’s OncoArendi Therapeutics.
The approval by Germany’s Federal Institute for Drugs and Medical Devices “is a major milestone, not only for the program, but also for the advancement of an entirely new class of drugs,” OncoArendi’s president and CEO, Marcin Szumowski, said in a press release. “It is also a significant milestone in the development of OncoArendi as it has now become a clinical-stage biotechnology company.”
OATD-01 is a potent non-steroid inhibitor that targets two enzymes — mammalian chitinase (AMCase) and chitotriosidase (CHIT1) — both of which are linked to inflammation, tissue injury and remodeling associated with asthma.
Preclinical data has demonstrated that OATD-01 can induce similar or even improved anti-inflammatory responses in experimental mice models compared to the only approved oral drug for asthma, Singulair (montelukast).
The Phase 1 clinical trial is a dose-escalating study expected to enroll about 48 healthy male participants. The volunteers will be randomly assigned to single-dose groups, either with oral OATD-01 or a placebo. The trial will evaluate several doses of OATD-01.
Evaluation of safety and tolerability profiles of OATD-01 are the study primary outcomes, which will be determined across all dose groups. For that, researchers will assess the nature and frequency of treatment-related adverse events, and perform biochemical and electrocardiogram tests. As a secondary outcome, researchers will evaluate OATD-01 distribution in the body, a parameter known as pharmacokinetics.
The data obtained from the this Phase 1 study is expected to provide information to guide the design of the next clinical trial, which will evaluate the effects of multiple-ascending doses of OATD-01. OncoArendi expectes to initiate the study’s next phase in early 2018.
“Our first dosing of OATD-01 represents the culmination of years of chemistry and biology discovery as well as chemical and preclinical development work,” said Stanislaw Pikul, vice president of development at OncoArendi. “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.”