CIN-109

CIN-110 was well-tolerated and demonstrated noteworthy decreases in caloric intake and weight compared to placebo based on topline interim data from Phase 1 single ascending dose (SAD) study CIN-109 produced meaningful weight loss and was generally well-tolerated across all dose levels in Phase 1 multiple ascending dose (MAD) study, including at the highest dose tested, where most weight loss was due to a reduction in fat mass while increasing lean mass CINCINNATI, OH, USA I November 03, 2024 I CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity, today announced topline interim data from its Phase 1 single ascending dose (SAD) study of CIN-110 and final data from its multiple ascending dose (MAD) study of CIN-109, with both programs demonstrating tolerability and meaningful weight loss. CIN-110 is a novel, long-acting PYY 3-36 analog designed to significantly reduce gastrointestinal (GI) side effects following subcutaneous (SC) administration. CIN-109 is a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) analog with the potential to decrease appetite, maintain energy expenditure, and drive weight loss while preserving lean body mass. “Despite limitations and side effects, weight loss drugs represent more than $6 billion in annual revenues globally, with projections reaching $150 billion by 2030. The compelling early-stage results from CIN-110 and CIN-109 lead us to believe we can overcome these limitations with next-generation approaches,” said CinRx Founder and Chief Executive Officer Jon Isaacsohn, M.D. “CIN-110’s ability to help safely and tolerably reduce caloric intake while quickly decreasing body weight after just a single dose distinguishes it as a high-potential candidate. Similarly, CIN-109’s significant impact on fat mass reduction and preservation of lean mass, especially at the highest doses, positions it as a powerful long-term solution.” The interim data from the CIN-110 double-blind Phase 1 SAD study showed it was well-tolerated and demonstrated encouraging caloric intake decreases and resulting weight loss compared to placebo after a single SC dose. Within just one week of dosing, food intake decreased by up to 28%, and body weight dropped by as much as 1.8%. The study was conducted with 24 otherwise healthy obese participants with a mean baseline weight and body mass index (BMI) of ~102 kg and ~34 kg/m 2 , respectively. CIN-110 is specifically designed to increase and sustain drug exposure gradually, minimizing the gastrointestinal side effects commonly seen with rapid increases in PYY levels following subcutaneous dosing. In total, three cases of mild nausea were reported, typically occurring within 12-48 hours after dosing and resolving within a day, even while CIN-110 levels remained near their peak. Pharmacokinetic results showed that CIN-110 levels in the body rose gradually, with peak concentrations typically reached within two to three days after dosing. These levels were sustained with an approximate 14-day half-life. No participants withdrew from the CIN-110 study due to adverse events, and all side effects were mild or moderate, with the moderate being unrelated to the digestive system. Results from the CIN-109 Phase 1 MAD study demonstrated it was well-tolerated and produced meaningful weight loss in the obese but otherwise healthy participants who completed the study. In the randomized, double-blind, placebo-controlled study, participants received CIN-109 once a week at doses of 5 mg, 10 mg, 15 mg, 20 mg, or 40 mg, or once every other week at doses of 20 mg, 40 mg, or 60 mg. The weekly group was treated for four weeks, while the group receiving CIN-109 every other week was treated for eight weeks. The mean weight and BMI of participants were ~100 kg and ~35 mg/m 2 , respectively. Participants experienced reductions in food intake, with dose-dependent decreases of up to 50%, and resulting weight loss of up to 3.7% within one to two months. Dosing every other week was better tolerated and the majority of weight lost represents fat mass. No serious side effects related to the treatment were observed. About CIN-110: CIN-110 is a potent, highly selective peptide YY (PYY 3-36 ) analog with an extended half-life, designed to significantly reduce the nausea and vomiting which has been observed with other PYY molecules while promoting effective, long-term weight loss. It is currently being evaluated in clinical trials to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The trials include single ascending dose (SAD) and multiple ascending dose (MAD) studies, with the MAD study building on the encouraging safety and tolerability data from the SAD study. About CIN-109: CIN-109 is a Phase 2 ready, a novel, long-acting, first-in-class growth differentiation factor 15 (GDF-15) analog for the treatment of obesity. CIN-109 is a Phase 2 ready candidate after successfully completing a randomized, double-blind, placebo-controlled multiple-ascending-dose study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity delivered subcutaneously. About CinFina Pharma: CinFina Pharma, a CinRx portfolio company, is expanding the treatment options for obesity and its associated comorbidities with a pipeline of therapeutic candidates designed to be safe, tolerable, and durable to help people lose weight and keep it off to improve their overall health. CinFina’s four therapeutic candidates are naturally occurring peptides engineered for prolonged activity that send signals to the body to control insulin secretion or feelings of satiety. Learn more at www.CinFina.com . About CinRx Pharma: CinRx Pharma is a biotech company advancing a diverse portfolio of high-impact medicines through clinical development with a unique hub-and-spoke business model. CinRx’s approach combines financing with the efficient progression of therapeutic candidates within its portfolio, each managed by CinRx’s central infrastructure and operating team. Current CinCos address areas of high unmet medical need, including metabolic, gastrointestinal, and oncology. Differentiated by an asset selection process agnostic to therapeutic area, a strategic CRO partnership, and insights from thousands of development programs, CinRx identifies, funds, and accelerates promising drugs with the potential to have the highest impact on patients’ quality of life. CinRx Pharma is headquartered in Cincinnati, Ohio. For more information, please visit www.CinRx.com or follow the company on X and LinkedIn . SOURCE: CinRx Pharma