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FDA Grants Orphan Drug Designation to Zymedi's ZMA001

01 Aug 2024
Admin
News Article

FDA Grants Orphan Drug Designation to Zymedi's ZMA001

FDA Grants Orphan Drug Designation to Zymedi's ZMA001 for Pulmonary Arterial Hypertension

Overview

Zymedi, led by CEO Sunghoon Kim, has announced that its novel antibody treatment, ZMA001, designed for pulmonary arterial hypertension (PAH), has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About PAH

PAH is a serious inflammatory vascular condition characterized by the narrowing and remodeling of pulmonary arterioles due to various factors.
This disease leads to immune cells infiltrating the lungs, damaging the pulmonary system, increasing arterial pressure, and eventually causing right ventricular failure and death.
The survival rate for PAH patients is comparable to that of cancer patients.

Symptoms and Cases

The disease initially presents with shortness of breath and progresses to symptoms like chest pain, fainting, and severe fatigue, significantly affecting daily life.
Approximately 70,000 people worldwide suffer from PAH, including around 6,000 in South Korea, making it a rare condition.

PAH Treatments

Current PAH treatments primarily involve vasodilators, which only manage symptoms and do not cure the disease.
Due to the varied causes of PAH, there is a significant need for targeted therapies.

ZMA001

ZMA001 is a human monoclonal antibody that works by preventing inflammation-inducing macrophages from infiltrating the lungs, thereby inhibiting the symptoms of PAH from early stages.
In preclinical studies with animal models, ZMA001 demonstrated greater efficacy than existing treatments.
Importantly, ZMA001 has shown enhanced effects when used in combination with current medications, suggesting it could be a transformative treatment in the PAH field, where new therapies are critically needed.

Optimistic Stand from Zymedi

Nam Hoon Kwon, Zymedi 's CTO, expressed optimism about the Orphan Drug designation for ZMA001, stating, ""We aim to provide an essential new treatment option for PAH patients.""
Kwon also highlighted the advantages of the FDA's Orphan Drug designation, including tax credits for clinical trial costs, seven years of market exclusivity upon approval, and development assistance.
These benefits are particularly helpful for startups with limited resources, supporting clinical advancement and commercial success.

Phase 1a Clinical Trial Proceedings

Zymedi commenced a Phase 1a clinical trial for ZMA001 at the NIH Clinical Center in January, involving healthy adult participants.
This phase is focused on assessing the drug's safety and tolerability in humans.
Early results will help determine the appropriate dosages and identify potential side effects, paving the way for subsequent clinical trial phases.