Resalis Therapeutics has announced the initiation of a Phase 1 clinical trial for RES-010, a novel non-coding RNA-based compound designed to address obesity by modifying disease pathways. The first-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RES-010 in healthy, overweight, and moderately obese volunteers.
Targeting miR-22 for Metabolic Reprogramming
RES-010 targets microRNA-22 (miR-22), a key regulator of lipid biosynthesis, mitochondrial function, and adipose tissue transformation. Preclinical studies have indicated that RES-010 reduces fat mass, preserves lean body mass, and enhances energy expenditure. This mechanism of action has the potential to offer a more durable solution by addressing the complex biological underpinnings of obesity.
"The initiation of our Phase 1 trial with RES-010 marks a significant milestone in our commitment to address obesity’s complex biological roots," said Almut Nitsche, Chief Medical and Development Officer of Resalis Therapeutics. "By targeting the miR-22 pathway, a key metabolic regulator, RES-010 is designed to selectively reduce fat while preserving muscle mass. This unique mechanism of action can potentially improve and extend the effectiveness of current obesity treatments."
Trial Design and Objectives
The Phase 1 trial (EUCT No: 2024-514871-17-00) is a randomized, double-blind, placebo-controlled study being conducted in the Netherlands. It consists of two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will involve up to 48 healthy male and female participants receiving incremental single doses of RES-010 to evaluate safety and pharmacokinetics. The subsequent MAD phase will include 24 overweight and 8 moderately obese participants receiving multiple doses to further assess RES-010’s safety and tolerability.
The primary objective of the trial is to assess the safety and tolerability of RES-010, while also evaluating its pharmacokinetic profile. Exploratory endpoints include assessing the effect of RES-010 on specific metabolic markers, changes in lipid metabolism, body weight, appetite, and glucose tolerance. Data from the combined SAD/MAD study are expected by mid-2026.
Potential to Complement Existing Therapies
RES-010 aims to reduce fat mass across various regions of the body, including visceral and hepatic stores, and has the potential to complement existing therapies such as GLP-1 receptor agonists, supporting sustainable, long-term weight management. Alessandro Toniolo, Chief Executive Officer of Resalis Therapeutics, stated, "With RES-010, we expect to shift the focus from managing symptoms in the short term to achieving durable, long-term impact on obesity."
