CinFina Pharma Reveals Promising Phase 1 Results for CIN-109 and CIN-110 at ObesityWeek® 2024

CinFina Pharma, part of the CinRx portfolio, has unveiled interim topline data from its Phase 1 single ascending dose (SAD) study of CIN-110 and final data from its Phase 1 multiple ascending dose (MAD) study of CIN-109. These results highlight both drugs' tolerability and their significant impact on weight loss. CIN-110, a novel, long-acting PYY 3-36 analog, is designed to mitigate gastrointestinal (GI) side effects following subcutaneous administration. CIN-109, a novel, long-acting growth differentiation factor 15 (GDF-15) analog, shows potential in reducing appetite, maintaining energy expenditure, and promoting weight loss while preserving lean body mass.

According to Jon Isaacsohn, M.D., Founder and CEO of CinRx, the global market for weight loss drugs, despite their limitations and side effects, is substantial, with projections soaring to $150 billion by 2030. The promising early-stage results from CIN-110 and CIN-109 suggest these next-generation drugs could address these limitations effectively. CIN-110's capability to safely and tolerably decrease caloric intake and promptly reduce body weight after just one dose underscores its potential. Similarly, CIN-109’s substantial effect on fat mass reduction while preserving lean mass, especially at the highest doses, makes it a strong candidate for long-term use.

The double-blind Phase 1 SAD study for CIN-110 demonstrated that the drug was well-tolerated, leading to significant reductions in caloric intake and weight loss compared to a placebo after a single subcutaneous dose. Within a week of dosing, participants' food intake dropped by up to 28%, and body weight declined by as much as 1.8%. This study involved 24 obese but otherwise healthy participants, with an average baseline weight of approximately 102 kg and a BMI of around 34 kg/m².

CIN-110 is engineered to gradually increase and maintain drug exposure, thereby minimizing the GI side effects usually seen with rapid spikes in PYY levels following subcutaneous administration. There were three instances of mild nausea, typically appearing within 12-48 hours post-dosing and resolving within a day, despite CIN-110 levels remaining near their peak. The pharmacokinetic data revealed that CIN-110 levels in the body climbed gradually, reaching peak concentrations within two to three days post-dosing and maintaining these levels with a half-life of about 14 days. All side effects were mild or moderate, and no participants withdrew from the study due to adverse events.

In the Phase 1 MAD study, CIN-109 showed it was well-tolerated and resulted in meaningful weight loss among the obese yet otherwise healthy participants. This randomized, double-blind, placebo-controlled study administered CIN-109 once a week at doses of 5 mg, 10 mg, 15 mg, 20 mg, or 40 mg, or once bi-weekly at doses of 20 mg, 40 mg, or 60 mg. The weekly treatment lasted for four weeks, whereas the bi-weekly group was treated for eight weeks. The average weight and BMI of participants were approximately 100 kg and 35 kg/m², respectively.

Participants experienced reductions in food intake, with dose-dependent decreases of up to 50%, leading to weight loss of up to 3.7% within one to two months. The bi-weekly dosing regimen was better tolerated, and the majority of weight lost was attributed to a reduction in fat mass. No serious treatment-related side effects were reported.

CIN-110, a potent, selective PYY 3-36 analog, aims to significantly reduce the nausea and vomiting commonly observed with other PYY molecules while promoting effective, long-term weight loss. It is currently under evaluation in clinical trials to determine its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity, with these trials encompassing both SAD and MAD studies. The encouraging safety and tolerability data from the SAD study have informed the ongoing MAD study.

CIN-109, a first-in-class GDF-15 analog, is designed for obesity treatment and is now Phase 2 ready following the successful completion of its Phase 1 MAD study, which assessed its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity when administered subcutaneously.

CinFina Pharma is focused on expanding treatment options for obesity and related comorbidities through a pipeline of therapeutic candidates aimed at being safe, tolerable, and durable, to help individuals lose weight and maintain weight loss, thus improving overall health.