Polish biopharmaceutical company OncoArendi Therapeutics is set to conduct a Phase I clinical trial of its lead drug candidate OATD-01 to treat patients suffering from asthma.

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The German Federal Institute for Drugs and Medical Devices (BfArM) has approved the trial.

OATD-01 is being developed as a potent dual inhibitor of acidic mammalian chitinase (AMCase) and chitotriosidase (CHIT1).

The randomised, double-blind, dose-escalation Phase I trial will investigate the safety, tolerability and pharmacokinetics of OATD-01 in 48 healthy male subjects enrolled in multiple dose cohorts within single dose-range.

OncoArendi Therapeutics president and CEO Marcin Szumowski said: “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.

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“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.”

The safety and tolerability of the drug candidate will be measured as primary outcome measures of the trial through assessment of nature and frequency of adverse events (AEs), laboratory assessments and electrocardiogram (ECG).

OncoArendi Therapeutics Development vice-president Stanislaw Pikul said: “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.”

Results obtained from the Phase I trial are expected to aid in designing the subsequent trial planned for next year to assess various increasing doses of OATD-01.

Image: Obstruction of the lumen of the bronchiole in an asthma patient. Photo: courtesy of Yale Rosen/Flickr.