CINCINNATI– CinRx Pharma, a mosaic of biotechnology companies accelerating transformational new medicines to patients, announced today the first study participant has been dosed in CinFina’s Phase 1 multiple ascending dose (MAD) study of CIN-109. CIN-109 is a novel, long-acting first-in-class growth differentiation factor 15 (GDF-15) analog being developed as a treatment for obesity. CinFina is a subsidiary ‘CinCo’ of CinRx dedicated to developing four novel, first-in-class therapies for obesity and weight loss and its associated co-morbidities. CIN-109 is the first to advance into Phase 1.
“Obesity is an alarming global public health priority with well-established links to many serious conditions. While there have been recent advances in the treatment of obesity, there is still a tremendous need to address it as a disease rather than a lifestyle issue with safe, accessible and effective therapies,” said Dr. Jon Isaacsohn, Founder and Chief Executive Officer at CinRx Pharma & CinFina Pharma. “CIN-109 represents a promising approach to achieving weight loss goals and overcoming, or preventing, the numerous associated health risks for people struggling with obesity and its impacts.”
The Phase 1 MAD study will assess safety, tolerability and pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CIN-109 following administration of multiple subcutaneous (SC) doses in obese, otherwise healthy subjects. The study is planned to include multiple escalating cohorts, each with 8 subjects randomized in a 3:1 ratio to receive CIN-109 or placebo, respectively. The safety, PK, PD, and immunogenicity of single SC doses ranging of CIN-109 were previously assessed in the first-in-human (FIH) single ascending dose (SAD) study conducted in overweight, otherwise healthy subjects. This study demonstrated a favorable safety, PK, and PD profile for CIN-109, thus supporting the continued clinical development of CIN-109. In the SAD study, there were no treatment-emergent adverse events (TEAEs) leading to discontinuation of the study drug or the clinical study.
“Developing new approaches to treating obesity is one of the most serious health challenges globally. Obesity has more than 60 related co-morbidities including hypertension, hyperlipidemia and type 2 diabetes, as well as increased risk of mortality,” explained Dr. Brian Murphy, Chief Medical Officer of CinFina. “Weight loss, even in modest amounts, can help improve and in some cases even alleviate these conditions. However, patients need better and more accessible therapies. CIN-109 shows promise as both a mono and combination therapy and I am eager to continue to evaluate its potential.”
