Randomized, double-blind, placebo-controlled study to evaluate efficacy of novel pan-GI prokinetic in patients with gastroparesis

Renexxion Ireland Limited, a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, is pleased to announce that the first patient has been treated in Europe with naronapride, a potential best-in-class pan-GI prokinetic, in a Phase IIb trial for gastroparesis conducted by Dr. Falk Pharma GmbH (Dr. Falk Pharma).

The Phase IIb trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of naronapride in patients with gastroparesis. Study investigators will enroll and randomize approximately 300 patients to receive either naronapride at 1 of 3 doses or placebo daily for 12 weeks. The primary endpoint of the trial is change from baseline in the signs and symptoms of either idiopathic or diabetic gastroparesis. Several additional secondary and exploratory endpoints will also be evaluated to further elucidate the efficacy and safety profile of naronapride, as compared to placebo.

Gastroparesis is a serious chronic disorder characterized by delayed gastric emptying leading to upper gastrointestinal symptoms such as nausea, vomiting or bloating. Gastroparesis is frequently associated with significant impairment of social and occupational functioning. Despite the high-unmet medical need, there is no approved drug in this indication available.

“At Renexxion Ireland, we are delighted to be working with Dr. Falk Pharma to bring naronapride to market in greater Europe. Naronapride accelerated gastric emptying in early clinical trials in the US and had a safety profile comparable with placebo in those studies. The results from this study will help further development of the drug for gastroparesis, a debilitating condition with a high unmet clinical need for which there are very few long term treatment options.”, said Peter Milner M.D., FACC, Chairman and CEO.

Roland Greinwald, PhD, Managing Director Medicine & Pharmaceutics of Dr. Falk Pharma GmbH, adds, “The initiation of the Phase II study MOVE-IT marks an important milestone in our endeavor of developing an effective and safe drug for the treatment of gastroparesis. Together with Renexxion Ireland it is our goal to help patients suffering from this debilitating disorder which at this stage lacks satisfying treatment options.”

The Phase IIb, multi-center, pan-EU clinical trial is being undertaken as part of a licensing and collaboration agreement with Dr. Falk Pharma, to evaluate the efficacy, safety and tolerability of naronapride in a cohort of subjects with gastroparesis. The study will form part of the clinical development plan for use of naronapride in gastroparesis. Topline results for the Phase IIb trial are expected in H1, 2025.

For more information:  http://www.rnexltd.ie.

For more information: https://drfalkpharma.com