CinDome Pharma Announces First Patient Dosed in the envision GI Phase 2 Clinical Trial of Deudomperidone (CIN-102) for the Treatment of Idiopathic Gastroparesis
CINCINNATI--(BUSINESS WIRE)--CinDome Pharma, a CinRx portfolio company dedicated to advancing a safe, chronic therapy for gastroparesis, today announced that the first participant has been dosed in the envision GI Phase 2 clinical trial of deudomperidone (CIN-102) in adults with idiopathic gastroparesis. Based on a strong safety signal and notable reductions in nausea and vomiting symptoms observed in a blinded interim analysis of the ongoing Phase 2 envision 3D study in patients with diabetic gastroparesis, CinDome has raised an additional $40 million of new capital to initiate this Phase 2 trial to investigate deudomperidone as a treatment for a broader population of patients with this chronic disease.
Gastroparesis, or delayed gastric emptying, occurs when the stomach does not empty normally, causing abdominal discomfort, severe nausea, or vomiting after eating. It represents an area of high unmet medical need impacting an estimated 12-16 million people in the U.S. alone, with an incidence rate growing on pace with diabetes. There is no long-term treatment option currently available. CinDome's deudomperidone is a new chemical entity being evaluated to address the unmet need in gastroparesis. Deudomperidone is a novel formulation of domperidone, a frequently prescribed first-line, short-term therapy for nausea, vomiting and gastroparesis outside the U.S., but it is not approved in the U.S. due to safety concerns around QT prolongation. CinDome's novel formulation of domperidone is designed to blunt peak concentration (C max) and extend half-life as compared to traditional domperidone. Deudomperidone is intended to provide similar or better therapeutic effects than domperidone with less QT liability.
'Based on observations from our ongoing envision 3D study of deudomperidone in patients with diabetic gastroparesis, we are confident that we have solved the safety issues seen with domperidone while maintaining its efficacy in reducing the debilitating symptoms of gastroparesis,' said Jon Isaacsohn, M.D., Founder and Chief Executive Officer of CinRx Pharma. 'The initiation of this additional study of deudomperidone will allow us to evaluate this candidate in a broader population of patients with gastroparesis. We look forward to advancing both studies to bring long-term relief to those suffering with this debilitating condition.'
About the CIN-102 Phase 2 Clinical Trial:
The phase 2 study is a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of CIN-102 (deudomperidone) in adult subjects with idiopathic gastroparesis. The total duration of study participation will be approximately 18 weeks, including a Screening Period and Lead-In Period of up to 5 weeks, a Double-Blind Treatment Period of 12 weeks, and a Follow-Up Period of up to 1 week. Approximately 400 subjects will be randomized into three treatment groups: 15 mg CIN-102, 10 mg CIN-102, or placebo, with an expectation that around 363 subjects will complete the 12-week Double-Blind Treatment Period. A blinded interim analysis is planned to coordinate with the end of the ongoing envision 3D Phase 2 diabetic gastroparesis study.
About CinDome Pharma:
CinDome, a CinRx portfolio company, is dedicated to filling the significant need for a safe, effective and tolerable treatment for the millions of people living with the devastating impact of chronic gastroparesis. With nearly 16 million adult patients in the United States experiencing symptoms of gastroparesis, a safe and effective treatment that can be taken on a chronic basis remains a significant unmet need. CinDome's CIN-102 is an engineered formulation of domperidone, the first line treatment for gastroparesis worldwide, which is not approved in the United States. Learn more at cindome.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.
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