FDA Approves Naronapride IND for Gastroparesis Treatment and US Phase 2b Study Expansion

Renexxion Ireland Limited, a biopharmaceutical firm dedicated to developing innovative treatments for gastrointestinal (GI) disorders, has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application. The application pertains to naronapride, a promising oral medication intended for the treatment of gastroparesis, a condition characterized by slow gastric emptying and associated symptoms such as nausea and vomiting. Often linked to diabetes, gastroparesis is a widespread yet underdiagnosed disorder affecting millions in the U.S. and the European Union, UK, and Australia.

Naronapride stands out as a potentially superior option due to its unique dual-action mechanism, targeting both the 5-HT4 receptor and the D2 receptor on the intestinal wall. This approach has demonstrated a differentiated profile in terms of pharmaceutical properties, pharmacokinetics, safety, and efficacy compared to other 5-HT4 agonists. The drug has already shown its ability to accelerate gastric emptying in a study involving healthy volunteers.

In response to the FDA's clearance, Renexxion and its European partner, Dr. Falk Pharma GmbH, plan to extend the patient recruitment for their ongoing Phase 2b clinical trial, known as the MOVE-IT study. This global, multi-center trial, which includes a placebo-controlled group of 320 patients, will now include clinical sites in the United States. The trial's primary results are anticipated to be announced in mid-2025.

The current standard of care for gastroparesis includes medications with limited effectiveness and potential side effects. Metoclopramide, the only FDA-approved drug for this condition in the U.S., carries a significant warning. Naronapride, with its demonstrated safety across four Phase 2 trials and its mechanism of action, presents a compelling alternative for the large patient population that remains underserved.

Dr. Peter Milner, Chairman and CEO of Renexxion, expressed enthusiasm for the FDA's approval and the opportunity to assist Dr. Falk Pharma in expanding the Phase 2b study to the U.S. He highlighted the growing prevalence of gastroparesis, particularly due to the rise in diabetes cases, and the potential use of naronapride as an adjunct therapy for GI side effects related to the use of GLP-1 agonists in obesity treatment.

Dr. Kai Pinkernell, Managing Director of Dr. Falk Pharma, echoed the sentiment, emphasizing the potential of naronapride to transform gastroparesis treatment and improve patient outcomes.

Naronapride is Renexxion Ireland's leading drug candidate, designed for GI indications in both the upper and lower GI tract. It has shown a unique combination of properties, being minimally absorbed and locally active in the gut, which may enhance both efficacy and safety. Four positive Phase 2 studies have been completed, and a Phase 2b study for PPI-non-responsive GERD is expected to start later this year following the FDA's clearance.

Renexxion Ireland, a subsidiary of California-based Renexxion, LLC, is a privately held company focused on GI disorder treatments. In addition to naronapride, the company is also advancing research in inflammatory bowel disease. Dr. Falk Pharma, with over 60 years of experience, specializes in developing and marketing innovative medicines for a range of GI and hepato-biliary disorders, emphasizing a commitment to improving patient care through research and development.