CinFina Pharma Announces FDA Clearance of Investigational New Drug Application and First Participants Dosed in Phase 1 Trial of CIN-110 for the Treatment of Obesity

CIN-110 is a potent and highly selective large molecule peptide YY (PYY_3-36) with an extended half-life being developed as a monotherapy and co-administration agent to induce satiety, reduce appetite and impact glucose metabolism

CIN-110 is the second therapeutic in CinFina’s metabolic portfolio to reach the in-human clinical trial milestone

CINCINNATI–(BUSINESS WIRE)–CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity and metabolic diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for CIN-110, a PYY_3-36 analog, allowing the first in-human clinical study to proceed. With the commencement of the trial, CinFina also announced the first cohort of participants has been dosed. The trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CIN-110 in a randomized, double-blind, placebo-controlled, single ascending dose study in otherwise healthy subjects with obesity.

“Despite the emergence of new medicines to help address the obesity epidemic, there remains an unmet medical need for therapeutics that are well tolerated for long-term treatment,” said Dr. Jon Isaacsohn, Founder and Chief Executive Officer at CinRx Pharma. “As demonstrated by promising preclinical efficacy data, CIN-110 has the potential to meet these needs and provide important therapeutic advantages to patients in monotherapy and combination settings, including durability of weight loss. We look forward to continuing to explore its safety and tolerability profiles in this important Phase 1 study.”

CIN-110 is a stable and long-acting analog of PYY_3-36 being developed both as a monotherapy and co-administration agent for obesity. PYY_3-36 is an endogenous hormone secreted in the gut, which activates the neuropeptide Y2 receptor (Y2R) to reduce appetite and food intake. Unlike prior attempts at developing a PYY focused therapeutic, CIN-110 is uniquely designed to limit severe nausea and emesis and still deliver on the promise of effective, long-term weight loss. CIN-110 selectively binds and activates Y2R, the target for native PYY_3-36. Pharmacodynamic evaluation of CIN-110 demonstrated that repeat subcutaneous dosing leads to significant reduction of food intake and body weight in obese, non-human primates and rodents. Additionally, data shows CIN-110 led to an improvement of glucose homeostasis and insulin sensitivity in animal models. The toxicology program results indicated that CIN-110 was well tolerated with no adverse findings noted in either non-human primates or rodents. The results from the preclinical efficacy and safety studies support the progression of CIN-110 to human clinical trials.

“The preclinical program of CIN-110 underscores the potential for PYY to be a differentiated approach to treat obesity. This uniquely engineered molecule holds promise to expand the current therapeutic paradigm beyond GLP-1s with its selectivity, potency and half-life extension,” said Brian Murphy, M.D., Chief Medical Officer at CinRx Pharma.

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 which send signals in 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.

Contacts

Media Contact:
Cassidy McClain

Account Director, Communications

[email protected]

CinRx Pharma Contact:
Jason Westerheide

Executive Director, Business Development

[email protected]