Evaluating first-in-class asset to potentially address current obesity treatment deficiencies by promoting weight loss and preserving lean body mass
WALTHAM, Mass., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Sironax, a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases, today announced it has achieved approximately 50 percent of targeted patient enrollment in its global Phase 2 FORGE-LM clinical trial. The double-blinded randomized, placebo-controlled, parallel-group trial (ACTRN12626001033336) is evaluating SIR4156, the company's first-in-class, orally active allosteric NAMPT (nicotinamide phosphoribosyltransferase) activator, in combination with semaglutide, in adults with obesity.
The primary objective of the trial, which remains on track, is to assess the effect of SIR4156 on body fat mass and body composition. Secondary objectives include evaluation of body weight, lean mass, safety, tolerability, pharmacokinetics, and pharmacodynamic effects.
"While the treatment of obesity has been transformed, significant unmet needs still remain-particularly related to lean muscle preservation, fatigue, sustained metabolic health, inadequate weight loss, and disproportional fat mass gain after cessation of therapies," said Dr. Shefali Agarwal, President and CEO of Sironax. "Our preclinical studies with SIR4156 provide a compelling rationale to investigate whether restoring NAD+ metabolism can deliver meaningful benefits in obesity as well as in metabolic and neuromuscular diseases. We are excited about the potential of SIR4156 and look forward to further advancing our NAMPT program."
NAMPT Activation and SIR4156
NAD+ (nicotinamide adenine dinucleotide) levels are critical for energy regulation, mitochondrial function, and tissue homeostasis but decline with age and metabolic dysfunction. By restoring NAD+ homeostasis and enhancing cellular energy metabolism, SIR4156 has the potential to address critical unmet needs associated with weight loss, including preservation of lean muscle mass and reduction of metabolically harmful fat. In multiple preclinical models, SIR4156 demonstrated preferential fat loss, lean-mass preservation, reduced muscle atrophy, and improved physical performance. At the recent Aging Research and Drug Discovery (ARDD) conference in Boston, Sironax presented scientific data on "Pharmacological Activation of NAMPT by SIR4156 Restores Tissue NAD+ and Improves Metabolic and Skeletal Muscle Function to Promote Healthy Aging in Mice."
About Sironax
Headquartered in Waltham, Massachusetts, Sironax is a global clinical-stage biotechnology company developing transformative therapies for neurodegenerative, inflammatory and immunologic, metabolic, and rare diseases. The company has built a diverse pipeline of programs by targeting contributors of aging: degeneration, metabolic dysfunction, and inflammation. In addition to NAMPT activator SIR4156, Sironax is conducting clinical studies with SARM1 inhibitor SIR2501 and RIPK1 inhibitor SIR9900, as well as ongoing preclinical research. The company was recently named to Fierce Biotech's "Fierce 15" list of the most innovative and promising private biotechs of 2026. For more information, visit sironax.com.
Forward-Looking Statements
SIR4156 is an investigational product candidate and has not been approved by the FDA or any other regulatory authority. Preclinical results may not be predictive of clinical outcomes. The safety and efficacy of SIR4156 in humans have not yet been established.
Contact Information
Investors/Media
Erik Kopp
Executive Director, Corporate Communications and Investor Relations
PR@sironax.com
Business Development
Yan Lu, Ph.D.
Senior Director, Business Development and Corporate Strategy
BD@sironax.com
