ALG-801 Phase 1b MAD Clinical Trial Success Announced by AliveGen

In Thousand Oaks, California, AliveGen USA Inc. has announced the successful conclusion of its Phase 1b multiple-ascending dose (MAD) clinical trial for the novel drug ALG-801. As a clinical-stage biopharmaceutical company, AliveGen focuses on pioneering treatments for muscle wasting, metabolic disorders, and neuromuscular diseases.

ALG-801, a cutting-edge ligand trap, selectively targets a subset of TGF-beta family proteins, including growth differentiation factors and activins. The Phase 1b trial, which was double-blind and placebo-controlled, was conducted with postmenopausal women. Key results from the study indicated that ALG-801 is safe and well-tolerated, showing linear pharmacokinetic properties and dose-dependent pharmacodynamic responses. Significant outcomes included muscle gain, fat loss, improved insulin sensitivity, and dual anabolic/anti-resorptive effects on bone, underscoring ALG-801’s potential to treat conditions like muscle wasting, obesity, cardiometabolic disorders, neuromuscular diseases, chronic kidney disease, liver issues, and age-related bone and muscle deterioration.

The drug's mechanism involves selectively inhibiting Smad2/3 signaling ligands, demonstrating notable efficacy and metabolic effects.

Following these positive Phase 1b results, AliveGen plans to move forward with Phase 2 clinical trials. Dr. HQ Han, CEO of AliveGen, expressed gratitude toward the participants and the medical professionals involved, emphasizing the promising data on muscle gain, fat loss, and insulin sensitization. Dr. Han highlighted ALG-801's potential to address a variety of unmet medical needs and anticipated the drug's advancement to the next phase of development.

AliveGen USA Inc. is dedicated to discovering and developing biotherapeutics aimed at treating serious muscle wasting and functional capacity loss associated with various metabolic and neuromuscular disorders, as well as age-related conditions.

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