Renexxion Ireland has announced that the first participant has been treated with its potential best-in-class pan-GI prokinetic, naronapride, in Europe in a Phase IIb trial to treat gastroparesis.
Conducted by Dr Falk Pharma, the double-blind, multi-centre, placebo-controlled, randomised Phase IIb trial has been designed for assessing the tolerability, safety, and efficacy of naronapride in gastroparesis patients.
Nearly 300 participants will be enrolled and randomised to receive either one of three naronapride doses or a placebo daily for 12 weeks.
The change in the signs and symptoms of either idiopathic or diabetic gastroparesis from baseline is the trial’s primary endpoint.
Renexxion Ireland stated that many other secondary and exploratory endpoints will also be assessed in the trial for further elucidating naronapride’s efficacy and safety profile, compared to a placebo.
Renexxion Ireland chairman and CEO Peter Milner said: “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 a 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.”
The company stated that the pan-EU Phase IIb clinical trial is being conducted as part of a licencing and collaboration deal with Dr Falk Pharma.
It will form part of the clinical development plan to use naronapride for the treatment of gastroparesis, a serious chronic disorder.
Renexxion Ireland expects to receive the topline data from the Phase IIb trial in the first half of 2025.