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=KYODO JBN/--

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:

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

Press@rnexltd.ie

+353 61 539121.

Source :Renexxion Ireland Ltd