Renexxion Ireland Limited announces opening of the Investigational New Drug (IND) application with the U.S Food and Drug Administration (FDA) for naronapride for the treatment of GI motility disorders in patients with cystic fibrosis (CF), a first step towards conducting clinical trials of this drug candidate in CF patients.
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Naronapride, post approval, could be a potential best-in-class pan-GI prokinetic for the treatment of GI Dysmotility in CF.
GI dysmotility in CF has a complex neuroendocrine pathophysiology causing significant morbidity and it is listed as a top research priority by patients.
GI dysmotility affects more than half of the patients with CF and is characterized by gastroparesis, abdominal pain, and severe refractory constipation.
Although there have been advances in the treatment of CF, there is still an unmet need for the treatment of GI symptoms.
Naronapride is a novel small molecule, pan-GI prokinetic with positive results from Phase II clinical trials in upper and lower GI indications and has demonstrated a comparable safety profile to placebo, making naronapride a potentially safe and effective treatment for GI dysmotility in CF.
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. ■