RES-010

TORINO, Italy I December 03, 2024 I Resalis Therapeutics today announced the initiation of its first-in-human, Phase 1 study for RES-010, a non-coding RNA-based compound designed to provide a disease-modifying approach to obesity treatment. Preclinical studies have demonstrated that RES-010 reduces fat mass, preserves lean body mass, and enhances energy expenditure. By targeting fat reduction across various regions of the body, including visceral and hepatic stores, RES-010 has the potential to complement existing therapies such as GLP-1 receptor agonists, and support sustainable, long-term weight management. The Phase 1 trial (EUCT No: 2024-514871-17-00 ) will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RES-010 in healthy, overweight, and moderately obese volunteers. “The initiation of our Phase 1 trial with RES-010 marks a significant milestone in our commitment to address obesity’s complex biological roots. 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,” said Almut Nitsche, Chief Medical and Development Officer of Resalis Therapeutics . “The trial is an essential step toward translating our preclinical insights into clinical advancements, paving the way toward a new generation of long-term obesity management treatments.” “Resalis has achieved the clinical development stage for RES-010 based on robust preclinical evaluation and a deep understanding of metabolic diseases, the non-coding RNA space, and RNA medicines. With RES-010, we expect to shift the focus from managing symptoms in the short term to achieving durable, long-term impact on obesity,” said Alessandro Toniolo, Chief Executive Officer of Resalis Therapeutics. “With this trial, we are committed to validating our approach and moving closer to a transformative solution for people living with metabolic diseases.” The Phase 1 trial is a randomized, double-blind, placebo-controlled study conducted in the Netherlands. It consists of two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. In the SAD phase, up to 48 healthy male and female participants will receive incremental single doses of RES-010 to evaluate safety and pharmacokinetics. The subsequent MAD phase will involve 24 overweight and 8 moderately obese participants who will receive multiple doses to further assess RES-010’s safety and tolerability. The trial’s primary objective is to assess the safety and tolerability of RES-010, while also evaluating its pharmacokinetics profile. Additionally, exploratory endpoints include assessing the effect of RES-010 on specific metabolic markers, change in lipid metabolism, body weight, appetite, and glucose tolerance. Data from the combined SAD/MAD study, which involves multiple phases of dose escalation and extensive safety evaluation, are expected by mid-2026. About RES-010 RES-010 is designed to reprogram metabolic pathways, providing a potential disease-modifying therapeutic impact that could include high-quality, sustained weight loss. By specifically targeting miR-22, a master regulator of lipid biosynthesis, mitochondrial function, and adipose tissue transformation, RES-010 has the potential to go beyond conventional obesity treatments that focus solely on appetite reduction. This targeted approach has the potential to offer a more durable solution, addressing the complex biological underpinnings of obesity. The regulation of these pathways may result in a reduction of fat mass across various body districts, including visceral fat and hepatic stores. With its robust preclinical results, RES-010 has the potential to complement and enhance the efficacy of existing anti-obesity drugs, such as GLP-1 receptor agonists, and may extend their impact by providing a more comprehensive therapeutic solution. About Resalis Therapeutics 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, Resalis Therapeutics 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 key company in the evolving landscape of obesity treatment. For more information visit our website www.resalistherapeutics.com . SOURCE: Resalis Therapeutics