Renexxion Announces Opening of Investigational New Drug Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
Renexxion Ireland's lead program is naronapride, a late-stage potential best-in-class drug candidate for unmet GI indications in the upper and lower GI tract. In scientific studies, naronapride has been demonstrated to possess a unique combination of both serotonin 5HT4 receptor agonistic and dopamine D2 receptor antagonistic properties, both clinically validated targets. Naronapride is designed to be minimally absorbable, is locally active in gut lumen, and in clinical studies its side-effect profile is indistinguishable from placebo. Four positive Phase II studies have been completed and naronapride is Phase III ready in chronic idiopathic constipation (CIC) and gastro-esophageal reflux disease (GERD).
Naronapride has been studied in 11 clinical studies and more than 1000 subjects to date. In these studies, naronapride has been well-tolerated with a safety profile that did not differ from the placebo-treated patients. Importantly, with naronapride no cardiovascular effects, including no effects on heart rate, blood pressure or ECG parameters, have been observed in clinical studies.
Renexxion Ireland Limited is an Irish privately held biopharmaceutical company, a wholly owned subsidiary of Renexxion LLC, committed to delivering new drugs to patients with GI disorders. Renexxion Ireland is currently collaborating with a leading European GI Licensing partner to advance naronapride through the later stages of development and commercialization in Greater Europe and certain other Australasian countries. Renexxion Ireland is currently advancing an additional research program in inflammatory bowel disease. (For information: https://www.prnewswire.com/news-releases/renexxion-ireland-ltd-announces-a-licensing-and-collaboration-agreement-with-dr-falk-pharma-gmbh-301392102.html ).
For more information: https://www.rnexltd.ie/
Contact: Catherine Pearson - Chief Operating Officer
+353 61 539121
View original content:https://www.prnewswire.co.uk/news-releases/renexxion-announces-opening-of-investigational-new-drug-ind-application-for-naronapride-for-the-treatment-of-gastrointestinal-dysmotility-in-cystic-fibrosis-patients-301715995.html