INCHEON, South Korea, July 30,
2024 /PRNewswire/ -- Zymedi (CEO Sunghoon Kim) announced that its first-in-class
antibody treatment ZMA001, currently in development for pulmonary
arterial hypertension (PAH), has been designated as an Orphan Drug
by the U.S. Food and Drug Administration (FDA).
Pulmonary arterial hypertension is an inflammatory vascular
disease characterized by the remodeling and narrowing of pulmonary
arterioles due to various causes. The infiltration of immune cells
from the blood into the lungs damages the pulmonary system,
increases pulmonary arterial pressure, and ultimately leads to
right ventricular failure and death, with a survival rate
comparable to cancer.
Initially manifesting as shortness of breath, PAH progresses to
chest pain, fainting, and extreme fatigue, severely impacting daily
life. Globally, approximately 70,000 people are affected by PAH,
with around 6,000 cases in South
Korea, making it a rare disease.
Currently, most treatments involve vasodilators, which only
alleviate symptoms without providing a cure. Due to the diverse
causes of PAH, there is a critical need for the development of
targeted therapies.
According to Zymedi, ZMA001 is a human monoclonal antibody that
blocks the infiltration of inflammation-inducing macrophages into
the lungs, thereby fundamentally inhibiting the symptoms of PAH
from the early stages. In preclinical development, animal model
studies demonstrated superior efficacy compared to existing
drugs.
Notably, ZMA001 has shown a synergistic effect when used in
conjunction with existing medications, positioning it as a
potential game-changer in PAH treatment, where innovative drugs are
urgently needed.
Zymedi's CTO Nam Hoon Kwon
stated, "With the Orphan Drug designation for ZMA001, we hope to
provide a valuable treatment option for PAH patients in need of new
therapies."
Kwon further emphasized, "The FDA's Orphan Drug designation
offers various benefits, including tax credits for clinical trial
costs, seven years of market exclusivity upon approval, and
assistance with the drug development process, which are
particularly advantageous for startup companies with limited
resources and time constraints, aiding in clinical progression and
commercial success."
Phase 1a clinical trial for ZMA001 began at the NIH Clinical
Center in January, involving healthy adult participants. This
initial phase focuses on evaluating the safety and tolerability of
the drug in humans. Preliminary results from these trials will help
determine the appropriate dosages and identify any potential side
effects, paving the way for subsequent phases of clinical
testing.
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 https://zymedi.com/
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SOURCE Zymedi