OncoArendi Therapeutics to Begin the Phase 1 Clinical Evaluation of its Novel Class of Medicines

 OncoArendi Therapeutics announced today that this week the Company will initiate a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of its lead compound, OATD-01. OncoArendi Therapeutics has been granted permission from the German Federal Institute for Drugs and Medical Devices (BfArM) to begin the first-in-human clinical evaluation of its novel drug candidate.

OATD-01, a potent dual inhibitor of acidic mammalian chitinase (AMCase) and chitotriosidase (CHIT1), was developed as an innovative, oral therapy for the treatment of asthma. OATD-01 is the first drug candidate targeting members of the chitinase family to enter clinical development. The data obtained from the Phase 1 study will guide the design of the subsequent trial, planned to begin in 2018, where multiple ascending doses will be evaluated.

"The initiation of the Phase 1 clinical trial of OATD-01 is a major milestone, not only for the program, 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.

About the Phase 1 Healthy Volunteers Study
This Phase 1, randomized, double-blind, dose-escalation study will evaluate OATD-01 in placebo-controlled cohorts, enrolling up to 48 subjects. The objective of the study is to investigate safety, tolerability and pharmacokinetics in healthy male volunteers evaluated in several dose cohorts within the single dose-range study. The primary outcome measures will evaluate the safety and tolerability of OATD-01 by assessing the nature and frequency of adverse events (AEs), laboratory assessments and electrocardiogram (ECG). Secondary measures will investigate the pharmacokinetics of OATD-01.

"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" said Stanislaw Pikul, VP of Development.