The completed Phase 1a study data in healthy volunteers showed early signs of pharmacodynamic activity supporting further clinical evaluation of RES-010

The Phase 1b study in healthy overweight and moderately obese participants is ongoing with data expected in H1 2027

Resalis Therapeutics announced topline data from the first-in-human study of its lead candidate, RES-010, a novel antisense oligonucleotide targeting microRNA-22 (miR-22). RES-010 is designed to address the underlying metabolic drivers of obesity to promote fat-selective weight loss while supporting durable metabolic benefits. Data from the unblinded Phase 1a single-ascending-dose study in healthy participants of normal body weight showed a favorable safety and tolerability profile for RES-010, alongside early pharmacodynamic signals. The ongoing Phase 1b trial is evaluating RES-010's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy, overweight, and moderately obese individuals in a multiple-ascending-dose trial.

“The initial safety and tolerability findings, together with the early pharmacodynamic signals, are encouraging as we evaluate RES-010’s potential to address the underlying biology of obesity,” says Diana Røpcke, Chief Medical Officer of Resalis Therapeutics. “In this single-ascending-dose study, we observed no severe adverse events, and the side effects reported were transient, manageable, and in line with the drug class. Pharmacodynamically, we are particularly interested in the associations observed between weight loss, baseline body mass index (BMI), and free fatty acid (FFA) levels, suggesting clear benefits in cases of metabolic dysregulation. With our Phase 1b multiple-ascending-dose study already underway, we look forward to building on these initial findings as we continue evaluating RES-010’s potential within obesity management beyond appetite suppression with focus on body composition benefits.”

“Weight loss alone is not enough to redefine obesity treatment. The real challenge is achieving meaningful fat loss while preserving metabolic health and maintaining the benefits over time, including after treatment ends,” says Alessandro Toniolo, Chief Executive Officer of Resalis Therapeutics. “RES-010 takes a fundamentally different approach by targeting a regulator of metabolic pathways, rather than relying on appetite suppression. Our ambition is to address the underlying biology of obesity and deliver high-quality, durable weight loss through a fundamentally differentiated mechanism. By targeting miR-22, we aim 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 our first-in-human study, particularly in individuals with higher baseline adiposity, provide encouraging initial clinical evidence as we advance toward demonstrating this mechanism in patients with obesity.”

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 MAD in overweight and moderately obese patients without obesity-related comorbidities. Topline data from the Phase 1b trial is expected in the first half of 2027.