Phase 2 enviva Study Initiates with First Participant Dosing for IBS-D Treatment CIN-103

A new drug formulation, CIN-103, is being developed to treat irritable bowel syndrome with predominant diarrhea (IBS-D). The compound, based on phloroglucinol, is designed to provide sustained exposure and maintain efficacy while reducing the frequency of dosing. This approach is aimed at addressing the complex condition affecting over 16 million individuals in the United States, where there are currently no approved long-term treatments.

The Phase 2 enviva clinical trial has commenced, with the first participant receiving the drug. The study will assess the safety, efficacy, and tolerability of CIN-103 in 450 adults suffering from IBS-D. The drug is a non-opioid small molecule that targets various aspects of IBS-D, including motility, secretion, pain, spasms, and inflammation.

Jon Isaacsohn, M.D., the founder and CEO of CinRx Pharma, highlighted that CIN-103 is an improved version of phloroglucinol, which is already approved in some countries for gastrointestinal disorders. The new formulation boasts enhanced pharmacokinetic properties, combining immediate-release and delayed-release processes for a proprietary pulsatile delivery system. This system is intended to offer sustained drug exposure with less frequent dosing while maintaining long-term efficacy.

Darren Brenner, M.D., a Professor of Gastroenterology Medicine & Surgery at Northwestern University’s Feinberg School of Medicine, expressed optimism about CIN-103's potential to fulfill an unmet medical need. He noted the drug's superior pharmacokinetic profile and absence of anticholinergic side effects compared to other antispasmodics.

The enviva study is a randomized, double-blind, placebo-controlled trial that will run for 12 weeks. It will evaluate the drug's impact on abdominal pain and stool consistency, with the goal of enrolling 450 participants.

CinPhloro Pharma, the company behind CIN-103, is part of the CinRx portfolio and is focused on developing a safe, effective, and long-term treatment option for IBS-D. CinPhloro's drug modification addresses the shortcomings of traditional phloroglucinol, such as its short half-life, and targets multiple IBS-D action points.

CinRx Pharma, CinPhloro's parent company, utilizes a unique business model to advance a diverse range of high-impact medicines. The company's approach involves a central infrastructure and operating team that manages a portfolio of therapeutic candidates, each addressing areas of significant unmet medical need, including metabolic, gastrointestinal, and oncology conditions. CinRx identifies, funds, and accelerates promising drugs that have the potential to greatly enhance patients' quality of life. The company is based in Cincinnati, Ohio.