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CINCINNATI, Sept. 19, 2019 (GLOBE NEWSWIRE) -- CinDome Pharma, Inc. (“CinDome”), a company whose lead product is deuterated domperidone (CIN-102), today announced that is has enrolled the first patient in a Phase 2 clinical trial of CIN-102. CIN-102 is being developed for the treatment of gastroparesis, a debilitating disease affecting five million people in the US¹ for which there are limited treatment options. CIN-102 is a new chemical entity, which was developed through deuteration and novel formulation processes. The compound is a peripherally selective dopamine (D2/D3) receptor antagonist and is expected to have prokinetic effects in gastroparesis patients, while addressing the associated symptoms of the disease. Non-deuterated domperidone is a well-known D2/D3 receptor antagonist used in many parts of the world for the treatment of nausea and vomiting and gastroparesis.
CinDome has completed two Phase 1 studies and is now initiating its Phase 2 programs. Phase 1 comprised a single ascending dose (SAD) study from 5 mg to 120 mg of CIN-102 and a multiple ascending dose study (MAD) up to 60 mg BID in healthy subjects. In these placebo-controlled Phase 1 studies, no safety concerns were identified. Within the anticipated therapeutic dose range of CIN-102, there was a substantial reduction in maximum plasma concentrations as compared to therapeutic doses of non-deuterated domperidone. Plasma concentrations were also more sustained with the half-life being more than twice that typically observed with non-deuterated domperidone. In addition, there was evidence of prolactin elevation at all dose levels and regimens studied, indicating appropriate target engagement. The pharmacodynamic (PD) effect on prolactin levels is suggestive of a similar efficacy profile compared to non-deuterated domperidone.
“We are encouraged by the safety, pharmacokinetics, and pharmacodynamic data obtained following administration of single doses and multiple doses of CIN-102 in the Phase 1 studies to date,” said Richard W. McCallum, M.D., FACP, FRACP (AUST), FACG, AGAF, professor and founding chair of the department of internal medicine at Texas Tech University Health Sciences Center El Paso (TTUHSC El Paso) and Lead PI on one of the two Phase 2 trials. “Gastroparesis is an area of unmet medical need, as the therapies currently available in the U.S. are limited and can cause undesirable side effects.”
CIN-102 is an innovative new chemical entity with a novel formulation with the potential to provide patients suffering from gastroparesis with an improved treatment option. Two Phase 2 studies are currently planned, and the results of these studies will guide future development. Further updates will be provided when available.
CIN-102 is a D2/3 antagonist developed through deuteration and novel formulation processes. CIN-102 has the potential to treat the large unmet need of patients suffering from gastroparesis and other medical gastrointestinal conditions. CinDome developed a process to replace specific hydrogen atoms in the chemical structure of domperidone with deuterium atoms.
Deuterium forms more stable bonds with carbon than hydrogen and therefore deuterium substitution can alter drug metabolism. By altering the metabolism of the compound, deuteration has the ability to alter the pharmacokinetics of the compound. This can lead to therapeutic benefits such as improved efficacy, safety, and tolerability.
Gastroparesis is a debilitating, chronic condition that has a significant impact on patients’ lives. It is characterized by slow or delayed gastric emptying and evidence of gastric retention in the absence of mechanical obstruction. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis.
About CinDome and CinRx Pharma
CinDome Pharma, a subsidiary of CinRx Pharma, is a biopharmaceutical company focused on the development of products to treat gastrointestinal disorders. CinRx brings a new approach to biopharmaceutical development, based on its team’s successful track record in the industry and a groundbreaking model for advancing product candidates designed to fill high-value gaps in pharma portfolios. The Company’s pipeline features assets across diverse therapeutic areas, ranging from large markets to orphan indications. For more information on CinDome, please visit www.cindome.com.
¹ International Foundation for Gastrointestinal Disorders (IFFGD) August 2016
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