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

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

Gastroparesis is a severe chronic disorder characterized by delayed gastric emptying that causes upper gastrointestinal symptoms such as nausea, vomiting, or bloating. Gastroparesis is frequently associated with significant impairment in social and occupational functioning. Despite the great unmet medical need, there is no drug approved for this indication.

"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 US clinical trials and had a comparable safety profile to placebo in those studies. The results of this study will help further develop the drug for gastroparesis, a debilitating disease with a high unmet clinical need for which there are very few long-term treatment options," said Peter Milner MD , FACC , President and CEO.

Roland Greinwald, PhD, Managing Director of Medicine and Pharmacy at Dr. Falk Pharma GmbH, added: "The initiation of the Phase II MOVE-IT study marks an important milestone in our quest to develop an effective and safe drug for the treatment of gastroparesis Together with Renexxion Ireland, our aim is to help patients suffering from this debilitating disorder which currently lacks satisfactory treatment options."

The multicentre, pan-European Phase IIb clinical trial is being conducted under a collaborative license 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 the use of naronapride in gastroparesis. The main results of the phase IIb trial are expected in the first quarter of 2025.

 

Source:prnewswire.com

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