Vial Launches Phase 1 Trial for Novel INHBE siRNA to Combat Obesity
Vial, a clinical-stage biotechnology company based in San Francisco, has announced the initiation of a Phase 1 clinical trial for its innovative siRNA therapy, VIAL-INHBE, designed for the treatment of obesity and cardiovascular metabolic disorders. This groundbreaking treatment, which utilizes a GalNAc-conjugated INHBE (Activin E) siRNA, aims to address significant healthcare challenges associated with obesity and its related comorbidities.
The Phase 1 open-label trial represents a pivotal moment in the journey to developing VIAL-INHBE, showcasing the company's commitment to advancing therapeutic options for individuals who struggle with obesity. According to Simon Burns, CEO of Vial, this trial marks a significant milestone in the program’s development, and Vial is eagerly anticipating interim results which are expected to be available in the first half of 2026.
Through its research, Vial has demonstrated promising results in preclinical studies using a Diet-Induced Obesity (DIO) mouse model. The data indicated that VIAL-INHBE could facilitate selective fat loss while preserving lean muscle mass. Furthermore, when combined with a lower dosage of GLP-1, the treatment exhibited synergistic effects, resulting in substantial weight loss and retention of lean mass even after cessation of GLP-1 treatment. This aspect holds considerable potential for improving patient adherence, as traditional GLP-1 therapies often lead to gastrointestinal side effects and higher rates of discontinuation.
The trial will assess various critical factors including safety, tolerability, pharmacokinetics, and pharmacodynamics associated with a subcutaneous administration of VIAL-INHBE. Notably, Vial plans to initiate a larger Phase 2 trial later in 2026 based on the outcomes of the Phase 1 study, broadening the scope of its research in targeting obesity.
One of the primary aims of VIAL-INHBE is to fill the gaps left by existing obesity treatments, particularly GLP-1 agonists, which, while revolutionary, have numerous drawbacks such as poor gastrointestinal tolerability, loss of lean mass, and the risk of weight regain once treatment is stopped. "Our preliminary findings highlight the potential for VIAL-INHBE to deliver similar weight loss results as higher doses of GLP-1 but with added benefits of preserving muscle mass and reducing weight rebound. This could change the treatment landscape for obesity management," noted Preeti Sareen, Ph.D., Head of Strategy at Vial.
The commitment of Vial to producing high-quality therapeutics is backed by over $100 million raised from leading investors like General Catalyst, Buckley Ventures, and Byers Capital since its inception in 2020. The company focuses on developing best-in-class biologics and RNA therapeutics aimed at addressing significant medical needs across various domains.
In conclusion, the initiation of the VIAL-INHBE Phase 1 trial not only signifies a significant advancement for Vial but also heralds potential new hope for patients battling obesity and its associated complications. With the trial's outcomes expected mid-next year, stakeholders are optimistic about the future of innovative treatments in this vital healthcare area.