Oneness Biotech Advances SNS851 to Phase 1 Multiple-Ascending Dose Evaluation for Obesity-Associated Metabolic Diseases

- First-in-Human Single Ascending Dose Study Establishes Initial Pharmacokinetic Profile of SNS851 in Healthy Volunteers -

- Multiple Ascending Dose Data Anticipated in Q1 2027 -

TAIPEI CITY, Taiwan--(BUSINESS WIRE)--Oneness Biotech Co., Ltd., a Taiwan-based biotechnology company advancing innovative drugs for metabolic disorders, today announced completion of the single-ascending dose (SAD) portion (Part A) in healthy volunteers of its ongoing Phase 1 clinical trial evaluating SNS851 as a potential treatment for obesity-associated metabolic diseases. The study is advancing to the multiple-ascending dose (MAD) portion (Part B), which will evaluate repeat doses of SNS851 in participants with fatty liver disease. Data from the MAD portion are anticipated in the first quarter of 2027.

In Part A, SNS851 demonstrated a dose-related pharmacokinetic (PK) profile in healthy volunteers, with systemic exposure increasing near-proportionally across the evaluated SAD dose range. Among 32 volunteers, one serious adverse event (SAE) - a foot fracture - was reported and considered unrelated to treatment.

SNS851 is an investigational small interfering RNA (siRNA) therapy that is designed to silence an undisclosed gene that affects liver mitochondrial activity and energy expenditure. It has a differentiated mechanism of action that targets energy metabolism rather than appetite suppression, a primary contributor to the weight-loss effects of standard-of-care GLP-1 therapies.

“We have completed the first-in-human single-ascending dose portion of our Phase 1 trial and advanced SNS851 to multiple-ascending dose evaluation to further expand the dataset,” said Shuling Cheng, PhD, CEO of Oneness (USA) Biotech. “SNS851 represents a potential first-in-class investigational approach to improving metabolic efficiency that may have broader relevance in obesity. We are engaging potential strategic partners to support global development of SNS851 as both a monotherapy and a complementary treatment to GLP-1-based therapies.”

In preclinical animal studies, SNS851 demonstrated systemic metabolic benefits, lowering random and fasting blood glucose and hemoglobin A1C (HbA1c), improving insulin sensitivity, and reducing liver fat compared to a control. SNS851 also prevented weight gain while reducing body fat and preserving muscle mass. In separate preclinical studies evaluating treatment with SNS851 in combination with a GLP-1 therapy at a 50%-reduced dose, the combination enhanced weight loss and showed greater metabolic effects than either monotherapy. Further, the combination demonstrated more durable weight loss following treatment discontinuation than that observed with GLP-1 monotherapy.

“Obesity is a complex metabolic disease, not simply a condition of overeating. Although appetite-reducing therapies benefit many patients, additional treatments are needed to address energy storage, use, and expenditure,” said Kuo-Ching Huang, MD, PhD, of National Taiwan University Hospital (NTUH). “SNS851 is being evaluated as a different approach to modulating energy use and fat metabolism, supporting its potential use as a standalone or in combination with GLP-1-based therapy.”

The Phase 1, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability, and PK profile of subcutaneous administration of SNS851. The trial is divided into two parts: Part A is a SAD portion in healthy volunteers, and Part B is a MAD portion in participants with fatty liver disease. The primary objective of the trial is to establish the safety and tolerability of SNS851 across Part A and Part B. The secondary objectives are to define the PK (plasma and urine) and immunogenicity (anti-SNS851 anti-drug antibodies) across Part A and Part B and to assess the exploratory effect on hepatic fat/metabolic markers in Part B.

More information about the trial is available at ClinicalTrials.gov (NCT Number: NCT07417124).

About SNS851

SNS851 is an investigational small interfering RNA (siRNA) therapy that is designed to silence an undisclosed gene that affects liver mitochondrial activity and energy expenditure. It has a differentiated mechanism of action that targets energy metabolism rather than appetite suppression, a primary contributor to the weight-loss effects of standard-of-care GLP-1 therapies.

About Obesity-Associated Metabolic Disease

Obesity is a chronic, complex, and relapsing disease characterized by excess body fat and underlying metabolic dysregulation. It is associated with an increased risk of numerous serious health conditions, including type 2 diabetes, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD), certain cancers, and other metabolic disorders. The World Health Organization (WHO) recognizes obesity as a major global public health challenge that continues to increase in prevalence. An estimated 1 in 8 people worldwide were living with obesity in 2022.¹ Despite the availability of effective treatments, obesity remains associated with substantial medical, social, and economic consequences.

About Oneness Biotech Co., Ltd.

Oneness Biotech Co., Ltd. is a publicly listed Taiwan-based biotechnology company (4743.TT) dedicated to the discovery and development of first-in-class and best-in-class innovative therapeutics and medical technologies addressing significant unmet medical needs. Founded in 2008, the company is advancing a diversified pipeline spanning wound care, immunology, dermatology, metabolic diseases, and novel nucleic acid-based medicines. Its portfolio includes approved products and investigational therapies designed to improve outcomes for patients with chronic and complex diseases, including diabetic foot ulcers, inflammatory disorders, and metabolic conditions. Through scientific innovation, global collaboration, and strategic partnerships, Oneness Biotech is committed to transforming breakthrough research into meaningful therapeutic advances that improve human health worldwide. Learn more about Oneness Biotech here: www.onenessbio.com/en.

Disclaimer
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Reference

1. World Health Organization. Obesity and Overweight Fact Sheet. Updated December 8, 2025. Available at: WHO Obesity and Overweight Fact Sheet. Accessed September 25, 2026.