Pulmongene Announces FDA Approval to Launch Phase IIb Clinical Trial for PMG1015, Achieving Major Milestone | Unity Ventures Portfolio
Establishing a leading position at the forefront of biopharmaceutical innovation
Unity Ventures portfolio company Pulmongene has announced that its first-in-class monoclonal antibody drug PMG1015 has received FDA approval to initiate a 52-week global multi-center Phase IIb clinical trial.
Pulmongene is a clinical-stage biotechnology company focused on lung, fibrotic, and autoimmune diseases, dedicated to discovering and developing innovative medicines. The company leverages cutting-edge science to translate research into critical therapies for patients worldwide, and has established a pipeline of multiple first-in-class drug candidates at both clinical and preclinical stages.
This approval marks a significant milestone in Pulmongene's development, establishing the company's leading position at the forefront of biologic drug innovation in this field.
Pulmongene Ltd. recently announced a major milestone: the U.S. Food and Drug Administration (FDA) approved the IND application for the PMG1015 Phase IIb clinical trial on January 10, 2026, allowing the Phase IIb trial to proceed.
PMG1015 is a first-in-class monoclonal antibody targeting Amphiregulin (AREG), a key driver of dysregulated fibrotic repair processes. By blocking the disease cascade at its furthest upstream point, PMG1015 has unique disease-modifying potential. As a biologic, PMG1015 is designed to reduce off-target toxicities commonly seen with small-molecule therapies.
The drug received FDA Orphan Drug Designation (ODD) for IPF in 2023. In the Phase Ib/IIa trial completed in 2025, PMG1015 demonstrated favorable safety and encouraging preliminary efficacy, including stabilization of key pulmonary function indicators (FVC) and improvement in AI-quantified HRCT imaging biomarkers.
This approval will initiate a 52-week, randomized, double-blind, placebo-controlled global multi-center clinical trial (MRCT). The study aims to comprehensively evaluate the long-term safety and efficacy of PMG1015, establishing Pulmongene at the forefront of biologic drug innovation in a field long dominated by small-molecule drugs.
The FDA's approval of a 52-week treatment period for the Phase IIb study represents strong validation of PMG1015's safety and its innovative mechanism of action (MoA). Compared to many mid-stage clinical trials that use 24-week endpoints, the 52-week trial duration is regarded as the "gold standard" for assessing the durability of a drug's effect in slowing lung function decline.
This approval underscores the FDA's confidence in Pulmongene's preclinical and early clinical data, further reinforcing PMG1015's potential to address the urgent unmet needs of the global idiopathic pulmonary fibrosis (IPF) population.
Dr. Nan Tang, Executive Chairperson of Pulmongene, stated: "Receiving FDA clearance to conduct this pivotal 52-week study is a significant milestone for Pulmongene. Existing standard therapies are often limited by tolerability issues and daily dosing burdens. Our goal is clear: we aim to demonstrate that PMG1015 can deliver disease-modifying efficacy with an improved safety profile and a more patient-friendly dosing regimen for long-term use. We are committed to reshaping the treatment landscape for IPF."
