AliveGen Presents Preclinical Data Showing ALG-801 Outperforms Standard Therapies in Pulmonary Arterial Hypertension Model

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THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Oct 1, 2025--

AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company, today announced new preclinical data demonstrating that its investigational therapy ALG-801 delivered superior efficacy compared to current standard-of-care agents in a widely accepted animal model of pulmonary arterial hypertension (PAH). The findings were presented at the European Respiratory Society (ERS) Congress, held September 27–October 1, 2025, in Amsterdam.

PAH is a progressive and life-threatening disease characterized by increased pulmonary vascular resistance, leading to elevated pulmonary arterial pressure, right heart failure, and premature death. Despite multiple approved therapies, median transplant-free survival remains only about six years, underscoring the urgent need for new treatments.

To assess ALG-801’s potential in PAH, researchers conducted head-to-head studies in sugen-hypoxia (SuHx) rats, a gold standard model for pulmonary hypertension, comparing ALG-801 with Sildenafil and ActRIIA-Fc (Sotatercept), both approved therapies for PAH.

Data Highlights

• During disease development: ALG-801 prevented pulmonary hypertension, right ventricular hypertrophy and pulmonary vascular remodeling more effectively than Sildenafil.
• In established PAH: ALG-801 was significantly more effective than ActRIIA-Fc, reversing elevated pulmonary arterial pressure, right ventricular hypertrophy, and pulmonary vascular remodeling. ALG-801 treatment also normalized circulating BNP levels and extended survival.

“These results demonstrate ALG-801’s ability to outperform approved PAH therapies in rigorous preclinical testing,” said Dr. HQ Han, CEO of AliveGen. “The data suggest that ALG-801 has potential to transform treatment outcomes for patients with PAH, where survival remains unacceptably poor despite recent advances.”

The findings position ALG-801 as a promising candidate for clinical development in PAH and related conditions.

About ALG-801

ALG-801 is a next-generation ActRIIA/IIB hybrid ligand trap designed to selectively block Smad2/3 pathway-activating ligands implicated in the pathogenesis of PAH and other diseases. ALG-801 has completed Phase 1a and 1b trials in healthy volunteers and is ready to advance into Phase 2 clinical studies. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ALG-801 for the treatment of PAH.

About AliveGen

AliveGen is a privately held, clinical-stage biotechnology company based in Thousand Oaks, California. The company is dedicated to developing first-in-class and best-in-class biotherapeutics for diseases with high unmet medical needs, including cardiometabolic disorders, obesity, neuromuscular diseases, age-related osteosarcopenia, and various wasting disorders. AliveGen’s mission is to improve care and quality of life for patients through innovative therapies that are both safe and highly effective. For more information, visit www.alivegen.com.

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CONTACT: Media and Investor Relations:

Xiaolan Zhou

AliveGen USA Inc.

[email protected]

KEYWORD: EUROPE UNITED STATES NETHERLANDS NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL GENERAL HEALTH HEALTH CLINICAL TRIALS OTHER HEALTH

SOURCE: AliveGen USA Inc.

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PUB: 10/01/2025 10:00 AM/DISC: 10/01/2025 10:02 AM

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