Study designed to continue assessing CIN-109’s safety and tolerability in obese, otherwise healthy people
CinFina Pharma, a CinRx portfolio company, announces advancements of one asset in its repertoire of mono- and combination-therapies for obesity
CINCINNATI – September 22, 2022 – 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.”
About the CIN-109 Phase 1 MAD Study
The MAD study is designed as a randomized, double-blind, placebo-controlled that will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CIN-109 delivered subcutaneously (SC). Study subjects are male and female ages 18-55 with a body mass index between 30.0 and 44.9 kg/m2, and otherwise healthy. The study is planned to include up to 11 cohorts, each with 8 subjects randomized in a 3:1 ratio to receive CIN-109 or placebo. Depending on the specific cohort, each subject will receive a minimum of 5 doses of CIN-109. Study drug will be administered as a single weekly or biweekly SC injection.
About CinFina Pharma:
CinFina, a CinRx portfolio company, is transforming the treatment of obesity and its associated comorbidities with a pipeline of therapeutic candidates designed to be safe, tolerable, durable and accessible to help people lose weight and keep it off to improve their overall health. CinFina’s four product candidates are naturally occurring peptides engineered for prolonged activity and send signals in the body to control insulin secretion or feelings of satiety. CIN-109 is CinFina‘s first program to reach the clinic.
About CinRx Pharma:
CinRx is a mosaic of biotechnology companies supported by a dedicated funding mechanism designed to improve drug development success and accelerate transformational new medicines to patients. By integrating our deep scientific, clinical and operational expertise with a thoughtful portfolio model, we establish the optimal development trajectory – a drug development superhighway. The company’s experienced team ensures high-potential medicines are financially and operationally championed with the most efficient route from the lab to the patient. For more information, please visit www.CinRx.com or follow the company on Twitter and LinkedIn.
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