CinDome Pharma announces successful completion of thorough QT study of CIN-102 (deudomperidone) in healthy subjects.
- CIN-102, Deudomperidone, is a novel, deuterium-containing, peripherally selective dopamine (D2/D3) receptor antagonist.
- Study demonstrated that therapeutic and ~5-fold supra-therapeutic concentrations of deudomperidone had no effect on the QT/QTc interval.
- Domperidone has been associated with an increased risk of QT prolongation and it has not received marketing authorization in the United States.
- Results of this study confirm a potential path to the first approval of a deudomperidone therapeutic in the United States.
- CinDome plans further clinical investigation in patients suffering from gastroparesis.
CINCINNATI, Jan. 25, 2022 (GLOBE NEWSWIRE) — CinDome Pharma, Inc. (“CinDome”), a clinical-stage biopharmaceutical company and member of the CinRx Pharma portfolio, today announced the negative results of a clinical thorough QT/QTc study of CIN-102 (deudomperidone) in healthy individuals. The clinical trial protocol achieved all cardiac safety objectives designed in accordance with the U.S. Food and Drug Administration (FDA) guidance.
This was a randomized, partially double-blind placebo- and active-controlled, single dose, four period, crossover study to assess the effect of CIN-102 on cardiac repolarization. Cardiac safety was assessed using serial ECGs extracted from continuous ECG recordings at prespecified time points starting at least one hour prior to dosing and ending approximately 48 hours post-dose in each period. The results indicate that plasma concentrations approximately 5-fold greater than maximum therapeutic concentrations following administration of CIN-102 have no clinically relevant effect on heart rate or on cardiac conduction.
“We are pleased that the results of this study confirmed CIN-102 has no clinically relevant cardiovascular effect – even at supratherapeutic levels” said Jon Isaacsohn, M.D., FACC, Chief Executive Officer of CinRx Pharma. “Domperidone is not approved for use in the United States, in part because of its increased risk of QT interval prolongation. These study results confirm that deudomperidone is safe. CinRx looks forward to rapidly advancing our clinical development work with additional trials to support patients with gastroparesis.”
About CIN-102
CIN-102, deudomperidone, is an innovative, novel entity developed through deuteration and novel formulation properties. The compound is a peripherally selective dopamine (D2/D3) receptor antagonist being developed to treat the large unmet need of patients suffering from gastrointestinal disorders. CIN-102 has been studied in Phase 1 studies in normal healthy volunteers and in a Phase 2 study in patients with either diabetic or idiopathic gastroparesis.
About CinDome & CinRx Pharma
CinDome Pharma, a subsidiary of CinRx Pharma, is a biopharmaceutical company focused on the development of CIN-102 (deudomperidone) to treat patients with gastrointestinal disorders. CinRx, a Cincinnati-based biotech company, acquires early-stage drug assets, housing these assets in therapeutically focused portfolio companies. CinRx seeks to rapidly advance each asset and create value to enable a successful exit, such as a licensing deal, a joint venture, or an IPO. For more information, please visit www.CinDome.com or www.CinRx.com.
Contact
Jason Westerheide
Executive Director, Business Development
jwesterheide@cinrx.com
