Deudomperidone (CIN-102) is a Dopamine 2/3 antagonist with prokinetic and antiemetic effects.
CIN-102
OVERVIEW:
CinDome’s deudomperidone (CIN-102) is a new chemIcal entity, based upon deuteration and novel formulation of domperidone, a frequently prescribed first line therapy for nausea, vomiting, and gastroparesis outside of the United States. In part due to safety concerns around QT prolongation, domperidone is not approved in the U.S. Deudomperidone has been engineered to alter the PK profile for sustained efficacy while significantly reducing cardiac liability. Currently, 20-50% of patients with gastroparesis use off-label treatments or go untreated, leaving a major unmet medical need and significant therapeutic development opportunity.
CinDome has studied deudomperidone in multiple clinical trials to date. Deudomperidone was well tolerated in these studies, and there were no sponsor-assessed drug related adverse events (AEs) or clinically meaningful laboratory abnormalities. Deudomperidone was deemed to have no meaningful impact on QT at exposures well above a therapeutic dose in a TQT study and demonstrated target engagement with trends of improvement in gastric emptying time in a previous Phase 2 clinical trial.
CinDome is currently enrolling the envision3D – Deuterated Domperidone in Diabetic GP – clinical trial. envision3D is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of deudomperidone (CIN-102) in adult subjects with diabetic gastroparesis after 12 weeks of treatment. To learn more about the clinical trial and participation information, please visit www.gastroparesistrial.com or NCT Number NCT05832151.
1. Rey E, Choung RS, Schleck CD, Zinsmeister AR, Talley NJ, Locke GR 3rd. Prevalence of hidden gastroparesis in the community: the gastroparesis “iceberg”. J Neurogastroenterol Motil. 2012 Jan;18(1):34-42
2. Jung HK, Choung RS, Locke GR 3rd, et al. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009;136(4):1225-1233
GASTROPARESIS
Metrics:
12-16 million patients in the US have symptoms of gastroparesis
>$4B annual prescription market in the US
Currently no chronic treatments available
REASONS
TO BELIEVE
- CIN-102 does not cross the blood brain barrier,unlike metroclorpramide, which is currently the only FDA-approved drug for gastroparesis and carries a black-box warning for tardive dyskinesia
- 20-50% patients with gastroparesis use off-label treatments or go untreated, leaving a major unmet medical need and significant therapeutic development opportunity
- CIN-102-121 Phase 2 study is signaling strong safety and efficacy
- A potential for GERD indication is being explored, which could extend the application of CIN-102 into an additional population with a large unmet medical need
