Resalis Therapeutics Begins Phase 1 Trial for RES-010 in Obesity

TORINO, Italy I December 03, 2024 I Resalis Therapeutics has commenced its inaugural human trial for RES-010, an innovative non-coding RNA compound aimed at modifying disease pathways to treat obesity. In preclinical studies, RES-010 demonstrated the capability to reduce fat mass, maintain lean body mass, and boost energy expenditure. The compound targets fat reduction in various body regions, including visceral and hepatic fat stores, potentially enhancing the effectiveness of existing treatments like GLP-1 receptor agonists and supporting sustainable long-term weight management.

The Phase 1 trial, identified as EUCT No: 2024-514871-17-00, will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RES-010 in healthy, overweight, and moderately obese participants. Almut Nitsche, Chief Medical and Development Officer at Resalis Therapeutics, emphasized the significance of this trial in addressing obesity’s intricate biological foundations. Nitsche highlighted that by targeting the miR-22 pathway, a crucial metabolic regulator, RES-010 aims to selectively reduce fat while preserving muscle mass, potentially enhancing and extending the benefits of current obesity treatments.

Alessandro Toniolo, Chief Executive Officer of Resalis Therapeutics, noted that reaching the clinical development stage for RES-010 is grounded in robust preclinical data and a comprehensive understanding of metabolic diseases and RNA medicines. Toniolo expressed optimism that RES-010 could shift the focus from short-term symptom management to achieving long-term impacts on obesity. The trial represents a commitment to validating this approach and moving towards a transformative solution for those with metabolic disorders.

The trial is a randomized, double-blind, placebo-controlled study conducted in the Netherlands, consisting 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 its safety and pharmacokinetics. Following this, the MAD phase will include 24 overweight and 8 moderately obese participants who will receive multiple doses to further assess safety and tolerability. The primary goal of the trial is to determine the safety and tolerability of RES-010 while also examining its pharmacokinetic profile. Secondary objectives include evaluating the compound's impact on specific metabolic markers, lipid metabolism, body weight, appetite, and glucose tolerance. Results from this comprehensive study, which involves multiple dose escalation phases and extensive safety evaluations, are anticipated by mid-2026.

RES-010 has been crafted to reprogram metabolic pathways, offering a potentially disease-modifying therapeutic effect that could result in high-quality, sustained weight loss. By specifically targeting miR-22, a master regulator of lipid biosynthesis, mitochondrial function, and adipose tissue transformation, RES-010 aims to go beyond traditional obesity treatments that focus mainly on appetite suppression. This targeted approach may provide a more durable solution by addressing the complex biological mechanisms underlying obesity. The regulation of these pathways could lead to a reduction in fat mass across various body regions, including visceral and hepatic fat stores. With promising preclinical results, RES-010 has the potential to complement and enhance the effectiveness of existing anti-obesity drugs, such as GLP-1 receptor agonists, by providing a more comprehensive therapeutic solution.

Resalis Therapeutics is committed to developing RNA-based therapies aimed at addressing the root causes of complex metabolic disorders. With extensive expertise in non-coding RNA and lipid metabolism, the company is advancing RES-010 as a safe, effective, and disease-modifying therapy, offering sustained weight loss and improved metabolic health. With strong preclinical data supporting its development, RES-010 is now entering clinical trials, positioning Resalis Therapeutics as a significant player in the evolving landscape of obesity treatment.