CINCINNATI–Â CinDome Pharma announced that the first patient has been dosed in its Phase 2 clinical trial, envisionGI, evaluating deudomperidone (CIN-102) for the treatment of idiopathic gastroparesis. The launch of this trial follows encouraging interim results from an earlier study showing that the drug was well tolerated and effective in reducing nausea and vomiting in patients with diabetic gastroparesis.
Gastroparesis is a chronic digestive disorder in which the stomach empties abnormally slowly, leading to symptoms such as bloating, abdominal pain, severe nausea, and vomiting. The condition affects an estimated 12 to 16 million Americans, and currently, there are no FDA-approved long-term treatments for the disease. Deudomperidone is being developed as a novel therapy to fill that gap.
CinDome, a portfolio company of CinRx Pharma, raised an additional $40 million to fund the new study and broaden the investigation of deudomperidone beyond diabetic gastroparesis to patients with idiopathic forms of the disease, which lack a known cause.
The investigational drug is a reformulated version of domperidone, a widely used short-term therapy for gastroparesis outside the United States. Domperidone is not approved in the U.S. due to concerns over QT interval prolongation, a heart rhythm issue. CinDome’s deudomperidone is designed to deliver similar or improved symptom relief with reduced cardiac risk, thanks to a modified formulation that lowers peak concentration and prolongs half-life.
“Based on observations from our ongoing envision3D study, we are confident that we have solved the safety issues associated with domperidone while preserving its therapeutic effect,” said Dr. Jon Isaacsohn, CEO of CinRx Pharma. “With the initiation of the envisionGI trial, we now have the opportunity to evaluate deudomperidone in a broader patient population and take a significant step toward addressing a long-neglected medical need.”
CinDome’s dual clinical program aims to establish deudomperidone as the first safe, long-term treatment option for gastroparesis in the United States.
