Renexxion Ireland Limited, in partnership with Dr. Falk Pharma GmbH in Europe, has obtained clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application concerning naronapride, intended for the treatment of gastroparesis. This condition, characterized by delayed gastric emptying and commonly accompanied by symptoms like nausea and bloating, affects a substantial number of individuals in regions such as the U.S., the European Union, the UK, and Australia, particularly among those with diabetes.

Naronapride, an orally administered medication, operates locally within the gastrointestinal tract as a pan-GI prokinetic by targeting both 5-HT4 receptors and D2 receptors. This dual mechanism offers potential advantages compared to existing treatments, promising a differentiated profile in terms of efficacy and safety. Renexxion and Dr. Falk Pharma are presently conducting a global Phase 2b MOVE-IT study involving 320 patients, expanding enrollment to include clinical sites in the United States. The study aims to assess the effectiveness and safety of naronapride in treating gastroparesis, with results expected in mid-2025.

Dr. Peter Milner, Chairman and CEO of Renexxion, expressed optimism about advancing the clinical development of naronapride, acknowledging the increasing prevalence of gastroparesis worldwide. He emphasized the drug's potential to address the expanding patient population affected by delayed gastric emptying, particularly in light of rising diabetes cases and the growing use of GLP-1 agonists, which can lead to gastrointestinal side effects necessitating prokinetic therapy.

Dr. Kai Pinkernell, Managing Director of Science & Innovation at Dr. Falk Pharma, echoed this sentiment, highlighting the collaborative effort to bring naronapride to market and its potential to transform gastroparesis treatment.

Naronapride, Renexxion Ireland's primary program, offers a novel approach to addressing unmet needs in gastrointestinal disorders. Its dual-action mechanism and favorable safety profile, demonstrated across multiple Phase 2 trials, position it as a promising candidate for treating gastroparesis and other GI conditions. Additionally, plans are underway for Phase 2b studies in PPI-non-responsive symptomatic GERD and Phase 3 readiness in chronic idiopathic constipation.

 

Source: globenewswire.com

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