CinRx Pharma portfolio company CinDome Pharma has dosed the first patient in its Phase II envision3D study of deudomperidone (CIN-102) for the long-term treatment of diabetic gastroparesis in the US.
The placebo-controlled, randomised, multicentre, double-blind study will evaluate the safety and efficacy of deudomperidone, a dopamine 2/3 antagonist with prokinetic and antiemetic effects.
The total duration of study participation is around 18 weeks, including a follow-up period of up to one week, a screening and lead-in period of less than five weeks, and a double-blind treatment period of 12 weeks.
This study expects to enrol around 400 patients of whom 363 subjects are expected to complete the double-blind treatment period of 12 weeks.
Deudomperidone’s safety will be assessed from the time of informed consent until the conclusion of the follow-up period while efficacy and adherence to study drug will be followed throughout the double-blind treatment period.
CinRx Pharma founder and CEO Dr Jon Isaacsohn said: “There are nearly 16 million people in the US living with symptoms of gastroparesis, and many millions more worldwide, without a safe, well-tolerated medicine that can be used for long-term disease management.
“Deudomperidone is a novel formulation of domperidone which we have designed to overcome the limitations of existing therapies. Importantly, deudomperidone has been clinically tested to demonstrate its low risk of QT prolongation at therapeutic doses, and it does not readily cross the blood-brain barrier enabling the extended use needed for the management of chronic gastroparesis.
“We remain encouraged about the potential for deudomperidone to bring long-term relief to those suffering from this challenging condition.”