AliveGen USA, Inc.

- Profound effects on muscle gain, fat loss, and insulin sensitization, along with a dual anabolic/anti-resorptive action on bone, pave the way for Phase 2 clinical development THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801. ALG-801 is a novel, next-generation ligand trap, which selectively sequesters a subset of TGF-beta family, including growth differentiation factors and activins. The Phase 1b MAD clinical study was conducted in healthy volunteers. This achievement marks a significant milestone in AliveGen’s mission to discover and deliver innovative therapies that address unmet medical needs. Key Highlights: Study Design: The Phase 1b MAD study is a randomized double-blind placebo-controlled trial in postmenopausal women. Safety Profile: ALG-801 was found to be safe and well-tolerated across all dosing cohorts. Efficacy Signal: ALG-801 exhibited linear pharmacokinetic (PK) exposures, along with dose-dependent and statistically significant pharmacodynamic (PD) responses. These included muscle gain, fat loss, and increased insulin sensitivity, as well as a dual anabolic/anti-resorptive effect on bone. These findings highlight ALG-801’s therapeutic potential in treating a wide range of medical conditions, such as muscle wasting, obesity, cardiometabolic disorders, neuromuscular diseases, chronic kidney disease, liver steatosis and fibrosis, and osteosarcopenia in old age. Differentiated Mechanism: By selectively inhibiting multiple ligands of the Smad2/3 signaling pathway, ALG-801 demonstrates an outstanding efficacy and metabolic effect. Next Step: Following the successful Phase 1b MAD study, AliveGen plans to advance ALG-801 to Phase 2 clinical development. “We are grateful to the healthy volunteers and healthcare professionals who actively participated in our Phase 1b clinical trial,” said HQ Han, MD, PhD, CEO of AliveGen. “We are thrilled with the excellent dose-response data on muscle gain, fat lose, and insulin sensitization from our Phase 1b MAD study. ALG-801, an innovative and powerful therapeutic approach, holds significant promise for addressing unmet needs across a diverse range of diseases. We look forward to advancing ALG-801 into Phase 2 clinical development.” About AliveGen AliveGen USA Inc. is a privately held biopharmaceutical company located in Thousand Oaks, California. The company is focused on the discovery and development of next-generation biotherapeutics to treat the debilitating muscle wasting and loss of functional capacity as occurs in various metabolic disorders, neuromuscular diseases, and age-related frailty.