ZMA-001

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 SOURCE Zymedi

SEOUL, South Korea, July 2, 2023 /PRNewswire/ -- Today Zymedi, a Korean biotech venture-backed company, announced the signing of a clinical Cooperative Research and Development Agreement (CRADA) with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to develop ZMA001 for the treatment of pulmonary arterial hypertension (PAH). The CRADA between Zymedi and the NHLBI will enable the organizations to collaborate together to advance the development of ZMA001. Zymedi will work with clinical investigators and researchers of the Intramural NIH PAH Translational Research Team to conduct a Phase 1, First-in-Human Clinical Trial in healthy volunteers. "We are excited to collaborate with the NIH to advance the development of ZMA001 for PAH," said Dr. Sunghoon Kim, CEO and Founder of Zymedi. "The NHLBI and the NIH Clinical Center are world-renowned institutions with a wealth of clinical expertise and resources, and we believe that this collaboration has the potential to bring meaningful benefit to patients in need." "Discovery and development of new and more effective therapies for PAH remains an unmet need. Therefore, ZMA001,a novel monoclonal antibody targeting pathways thought to play a key role in PAH pathogenesis, may contribute to meeting this important goal.," said Jason Elinoff, MD, co-director of the NHLBI Translational Pulmonary Arterial Hypertension Program and NHLBI Principal Investigator of the upcoming Phase 1 study. "This collaborative research partnership will initially focus on establishing the safety of this agent in humans. Correlative research studies from this trial as well as future planned trials will be aimed at exploring whether ZMA001 will halt or reverse disease progression in PAH." The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Zymedi Zymedi is a global biopharmaceutical company that is committed to discovering and developing innovative treatments for patients with serious and life-threatening conditions. SOURCE Zymedi