Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, January 11 2023 - 00:00
Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
ROSCREA, Ireland, Jan.10, 2023 /PRNewswire-AsiaNet/--

Renexxion Ireland Limited (Renexxion), a private biopharmaceutical company 
committed to delivering innovative drugs to patients with high unmet need in 
gastrointestinal ("GI") disorders, is pleased to announce 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. 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.

"We are very excited about the potential of naronapride to improve the quality 
of lives of individuals with CF. Following discussions with the CF Foundation, 
CF Key Opinion Leaders and our European partner; we have identified a high 
unmet need for the treatment of GI dysmotility in CF. We have received 
constructive input from the FDA on both our clinical development plan and Phase 
II clinical trial design. Receiving IND clearance represents a major milestone 
in moving forward with our clinical development plan in parallel with our 
partner in EU in gastroparesis", said Peter Milner M.D., FACC, Chairman and CEO.

"The global cystic fibrosis patient community remains in need of effective 
treatments for gastrointestinal motility complications like constipation and 
gastroparesis.  Despite advances in treatments for the pulmonary complications 
of cystic fibrosis, no pro-motility drugs have replaced cisapride since its 
withdrawal from the market," said Zachary Sellers, MD, PhD, Assistant Professor 
of Pediatrics-Gastroenterology at Stanford University School of Medicine. 

Confirming the unmet need for a GI promotility agent in patients with CF, 
Dhiren Patel, M.D., Associate Professor of Pediatrics at the St. Louis 
University School of Medicine said, "We welcome clinical trials of naronapride 
in cystic fibrosis patients with gastrointestinal motility disorders.  If 
naronapride is proven to be effective in treating these patients, it would 
significantly improve their quality of life."

About Naronapride:

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.

About Renexxion:

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: ). 

For more information:

Contact: Catherine Pearson - Chief Operating Officer
+353 61 539121.

Source :Renexxion Ireland Ltd