CinRx Pharma Announces First Participant Dosed in CinDome’s Phase 2 Study of Deudomperidone (CIN-102) for the Treatment of Diabetic Gastroparesis

CINCINNATI--(BUSINESS WIRE)-- CinRx Pharma, a mosaic of biotechnology companies accelerating transformational new medicines to patients, today announced that the first study participant has been dosed in CinDome Pharma’s Phase 2 envision^3D study of deudomperidone (CIN-102) in patients with diabetic gastroparesis. Deudomperidone is a Dopamine 2/3 antagonist with prokinetic and antiemetic effects being evaluated for the chronic treatment of patients who currently have no therapeutic options for long term management. Gastroparesis is a syndrome defined by delayed gastric emptying in the absence of any physical obstruction and symptoms include bloating, nausea, vomiting, postprandial fullness, and early satiety.

“There are nearly 16 million people in the U.S. 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,” explained Dr. Jon Isaacsohn, Founder and Chief Executive Officer of CinRx Pharma. “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 management of chronic gastroparesis. We remain encouraged about the potential for deudomperidone to bring long-term relief to those suffering with this challenging condition.”

The Phase 2 envision^3D study is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of deudomperidone in adults with diabetic gastroparesis after 12 weeks of treatment.

About Deudomperidone (CIN-102)

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 US. 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.

Multiple clinical trials of deudomperidone have been completed 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 thorough QT study and demonstrated target engagement with trends of improvement in gastric emptying time in a previous Phase 2a trial.

About the Deudomperidone Phase 2 envision^3D Study

The Phase 2 study is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of deudomperidone in adult subjects with diabetic gastroparesis. The safety of deudomperidone will be assessed from the time of informed consent until the end of the Follow-Up Period. Subjects will be followed for efficacy and adherence to study drug throughout the Double-Blind Treatment Period. The total duration of study participation will be approximately 18 weeks including a Screening Period and Lead-In Period of <5 weeks, a Double-Blind Treatment Period of 12 weeks, and a Follow-Up Period of up to 1 week. Approximately 400 subjects will be randomized with 363 subjects anticipated to complete the 12-week Double-Blind Treatment Period.

About CinDome Pharma

CinDome, a CinRx portfolio company, is dedicated to filling the significant need for a safe, effective and tolerable treatment for the millions of people living with the devastating impact of chronic gastroparesis. With nearly 16 million adult patients in the US experiencing symptoms of gastroparesis, a safe and effective treatment that can be taken on a chronic basis remains a significant unmet need. CinDome’s deudomperidone (CIN-102) is an engineered formulation of domperidone, the first line treatment for gastroparesis worldwide, which is not approved in the US.

About CinRx Pharma

CinRx is a mosaic of biotechnology companies supported by a dedicated funding mechanism designed to improve drug development success and accelerate transformational new medicines to patients. By integrating our deep scientific, clinical, and operational expertise with a thoughtful portfolio model, we establish the optimal development trajectory – a drug development superhighway. The company’s experienced team ensures high-potential medicines are financially and operationally championed with the most efficient route from the lab to the patient. For more information, please visit www.CinRx.com or follow the company on Twitter and LinkedIn.

1. Financing includes $11M of equity and $8M convertible note.

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