Currently, there are no FDA-approved long-term treatments for gastroparesis available in the US. Credit: Poonam R Kuthe / Shutterstock.com.

CinDome Pharma has secured $40m in a Series B financing extension round aimed at progressing the development of deudomperidone (CIN-102) as a potential treatment for chronic gastroparesis.

This additional investment was contributed by existing investors of the company, including Perceptive Advisors and CinRx Pharma.

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The latest funding takes the total capital raised in the Series B funding round to $59m.

The capital injection is set to bolster the ongoing Phase II envision3D study of deudomperidone in adults with diabetic gastroparesis and prepare the company for registrational trials.

Gastroparesis, a condition characterised by delayed gastric emptying, affects an estimated 12-16 million individuals in the US, with prevalence increasing in tandem with diabetes rates.

Currently, there are no approved long-term treatments approved by the US Food and Drug Administration (FDA) available in the region.

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Deudomperidone, a new chemical entity, is being investigated by CinDome to fill this gap as a new formulation of domperidone, a commonly prescribed therapy for nausea, vomiting, and gastroparesis in countries outside the US.

Due to safety concerns, particularly regarding QT prolongation, domperidone is not approved for sale in the US market.

However, deudomperidone has been specifically engineered to modify the pharmacokinetic profile to maintain efficacy while reducing cardiac risks.

In multiple trials, deudomperidone was found to be well tolerated without any sponsor-assessed drug-related adverse events or lab abnormalities reported.

Furthermore, in a thorough QT study, deudomperidone showed no meaningful impact on QT intervals at doses exceeding therapeutic levels.

It also demonstrated target engagement and a positive effect on gastric emptying time in a previous Phase IIa trial.

CinRx Pharma founder and CEO Dr Jon Isaacsohn said: “This increased investment in CinDome extends our important, ongoing development activities and enables readiness for deudomperidone to enter late-stage trials.

“We are grateful for the continued support and partnership from Perceptive Advisors to advance this high-impact therapeutic and bring a new hope to people impacted by gastroparesis.”