THOUSAND OAKS, Calif.--(BUSINESS WIRE)--AliveGen USA Inc. (AliveGen), a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ALG-801 for the treatment of pulmonary arterial hypertension (PAH), a rare, serious, and life-threatening condition characterized by high blood pressure in the lung arteries that can lead to right-sided heart failure.
“FDA’s Orphan Drug Designation for ALG-801 underscores the need for identifying better treatment options for patients suffering from PAH,” said Dr. HQ Han, CEO of AliveGen. “The designation represents another milestone in AliveGen’s efforts to discover and develop first-in-class/best-in-class therapeutics for high unmet medical needs. We believe that ALG-801, which has demonstrated superior efficacy and improved safety profile in preclinical and clinical Phase 1 studies, holds a remarkable potential to become a best-in-class medicine for PAH. We look forward to progressing ALG-801 clinical development.”
The FDA Orphan Drug Designation program is granted to drugs and biologics intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides benefits to sponsors designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include tax credits for clinical costs, exemptions from certain FDA fees, and potential seven years of marketing exclusivity.
About ALG-801
ALG-801 is a novel next-generation ActRIIA/IIB hybrid ligand trap designed to selectively sequester a specific set of Smad2/3 pathway-activating ligands, which are critically involved in the pathogenesis of PAH as well as of many other diseases. ALG-801 has successfully completed its Phase 1a and 1b clinical trials in healthy volunteers and is ready for Phase 2 clinical development.
About AliveGen
AliveGen is a privately held clinical-stage biotechnology company located in Thousand Oaks, California. The company aims to discover first-in-class/best-in-class biotherapeutics for treating diseases with high unmet medical needs such as cardiometabolic disorders, neuromuscular diseases, age-related osteosarcopenia, and various wasting disorders. The company aspires to improve the care and quality of life of patients by developing innovative therapies that are safe and highly effective. Learn more about AliveGen on its website: www.alivegen.com.
