First in Human Dosed in Clinical Trial of ZMA001 for Treatment of Pulmonary Arterial Hypertension (PAH)
2024-02-08
临床1期
INCHEON, South Korea, Feb. 7, 2024 /PRNewswire/ -- Zymedi announced today that the first in human dosage of ZMA001, a monoclonal antibody being developed as a first-in-class treatment for Pulmonary Arterial Hypertension (PAH) has been initiated.
The placebo-controlled phase 1 trial designed to ascertain the safety and dosage of ZMA001 is a collaborative effort between Zymedi and the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). In the preceding year, both organizations entered into a Cooperative Research & Development Agreement (CRADA) in order to work together to advance the development of ZMA001.
PAH is a serious and life-threatening condition affecting approximately 3 persons per 100,000 globally, with about 500 to 1,000 new cases diagnosed annually in the U.S. It is characterized by the narrowing of pulmonary arteries, a rise in pulmonary vascular resistance, and eventually death due to right heart failure.
Current treatments for PAH, such as vasodilators, reduce symptoms but do not treat the underlying cause of the problem. ZMA001 is a first-in-class therapeutic antibody targeting the novel pro-inflammatory factor KARS1 that is specific to monocytes and macrophages. It can improve both the survival rates and the quality of life of PAH patients by eliminating the root pathologic cause of PAH.
"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," said Dr. Sunghoon Kim, CEO and Founder of Zymedi. "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 (MTD) for forthcoming phase 1b/2a clinical trials involving patients."
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About ZMA001
ZMA001 is a human monoclonal antibody designed to control or inhibit inflammation responses in pulmonary blood vessels by blocking lysyl-tRNA synthetase (KARS1)-dependent infiltration of monocytes and macrophages. ZMA001 specifically targets membrane-exposed KARS1 without affecting its catalytic activity for protein synthesis. It can assure specificity toward response, disease indication, immune system, and target biology without inducing the systemic hypotension frequently observed with other typical treatments using vasodilators. ZMA001 with its novel MOA, is expected to treat PAH by eliminating its root pathologic cause unlike other treatments such as vasodilators that only address the symptoms.
About Zymedi
Zymedi is a global biopharmaceutical company that is committed to transforming the role of ARSs (Aminoacyl-tRNA Synthetases) and targeting it as a method of discovering and developing innovative treatments for patients with serious and life-threatening conditions that have no standard of care or lack effective therapy.
For more information, please visit www.zymedi.com
SOURCE Zymedi
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