Resalis Therapeutics Reports Favorable Phase 1a Data for RES-010

Resalis Therapeutics today announced the completion of a Phase 1a study for its lead candidate, RES-010, a novel antisense oligonucleotide targeting microRNA-22 (miR-22). The study, which included 48 healthy participants of normal body weight, demonstrated a favorable safety and tolerability profile for RES-010, alongside early pharmacodynamic signals. These signals suggest potential for fat-selective weight loss while supporting durable metabolic benefits.

The ongoing Phase 1b trial, evaluating RES-010's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy, overweight, and moderately obese individuals, is currently underway. This multiple-ascending-dose study is being conducted in Australia and is expected to provide top-line data in the first half of 2027.

The Phase 1 trial is a double-blind, randomized, placebo-controlled, single- and multiple-ascending-dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamic profile of RES-010. The Phase 1a part of the trial (EUCT No: 2024- 514871-17-00) included 48 healthy participants of normal body weight who received incremental single doses of RES-010. Resalis is currently finalizing the Phase 1b part of the trial in Australia, evaluating multiple ascending doses in overweight and moderately obese patients without obesity-related comorbidities.

Resalis Therapeutics is dedicated to developing RNA-based therapies that tackle the root causes of complex metabolic disorders. With its deep expertise in non-coding RNA and lipid metabolism, the company is advancing RES-010 as a safe, effective, and disease-modifying therapy that offers sustained weight loss and improved metabolic health. Supported by robust preclinical data and ongoing clinical evaluation, RES-010 positions Resalis Therapeutics as a key player in the evolving landscape of obesity treatment.

The company's ambition is to address the underlying biology of obesity by targeting a regulator of metabolic pathways, rather than relying on appetite suppression. RES-010 is designed to shift metabolism toward greater fat utilization and energy expenditure, supported by compelling preclinical evidence of adipose tissue thermogenesis. The early weight-loss signals observed in the first-in-human study, particularly in individuals with higher baseline adiposity, provide encouraging initial clinical evidence as the company advances toward demonstrating this mechanism in patients with obesity.

The Phase 1a study data from the unblinded single-ascending-dose trial in healthy participants of normal body weight showed no severe adverse events, with side effects reported being transient and manageable. The pharmacodynamic signals observed suggest associations between weight loss, baseline body mass index (BMI), and free fatty acid (FFA) levels, indicating potential benefits in cases of metabolic dysregulation. The ongoing Phase 1b trial is expected to provide further insights into the safety, tolerability, pharmacokinetics, and pharmacodynamics of RES-010 in a broader patient population.

Resalis Therapeutics, backed by investors including Claris Ventures, Sunstone Life Science Ventures, and Sanofi, is committed to advancing RNA-based therapies that address the root causes of complex metabolic disorders. The company's focus on developing RES-010 as a safe, effective, and disease-modifying therapy underscores its commitment to delivering high-quality, durable weight loss and improved metabolic health.