Korean biotech venture-backed company Zymedi has dosed the first subject in a Phase I clinical trial of a monoclonal antibody, ZMA001, being developed to treat PAH.
This trial marks a significant milestone in the collaborative effort between Zymedi and the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
The placebo-controlled trial aims to evaluate the safety and optimal dosage of ZMA001 to treat PAH.
Last year, Zymedi and the NHLBI signed a Cooperative Research & Development Agreement (CRADA) to progress the development of this drug.
ZMA001 operates by controlling or inhibiting inflammatory responses in the pulmonary blood vessels.
It does this by blocking lysyl-tRNA synthetase (KARS1)-dependent infiltration of monocytes and macrophages, without impacting KARS1’s catalytic activity essential for protein synthesis.
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This specificity could offer a targeted approach to PAH treatment, addressing the root pathologic cause rather than just alleviating symptoms.
Unlike presently marketed PAH treatments that primarily use vasodilators to reduce symptoms, ZMA001’s mechanism of action has the potential to boost survival rates and quality of life by addressing the underlying cause of the disease.
A severe condition, PAH leads to the narrowing of pulmonary arteries and can result in right heart failure if left untreated.
Zymedi focuses on the discovery and development of therapies to treat patients with serious and life-threatening conditions that presently have no standard of care or lack effective treatment.
Zymedi CEO and founder Dr Sunghoon Kim said: “We are excited to initiate this first in-human trial of ZMA001, which marks a significant milestone for our company and the fight against PAH.
“We are scheduled to assess the safety and tolerability of ZMA001 through dose escalation clinical trials, systematically observing adverse reactions as dosage increases.
“Furthermore, we aim to establish the recommended dosage and determine the maximum tolerated dose for forthcoming Phase Ib/IIa clinical trials involving patients.”