Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD

ROSCREA, Ireland, Jan. 24, 2024 (GLOBE NEWSWIRE) — Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, announces U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application of naronapride for the treatment of patients with proton-pump inhibitor (PPI) non-responsive symptomatic gastroesophageal reflux disease (GERD) (PPI-nrsGERD). Naronapride is a potential best-in-class oral, locally acting pan-GI prokinetic, which works by modulating two validated targets on the luminal surface of the intestinal wall, 5-HT₄ receptor agonism and D₂ receptor antagonism, with a well-differentiated pharmaceutical, pharmacokinetics, safety, and efficacy profile from other 5-HT₄ agonists.

GERD is a multifaceted chronic condition that is estimated to affect approximately 70 million patients in the U.S., of which up to 30-40% continue to manifest symptoms despite first-line treatment with PPIs. PPIs focus solely on the mechanism of acid suppression without addressing gastrointestinal (GI) motility. As such, the potential use of prokinetic therapies, such as the Company’s naronapride, may represent an important adjunctive therapeutic approach to treating these patients considering that impaired GI motility can be a contributing factor in GERD, particularly in patients who are PPI non-responsive.

“Published evidence suggests that the combination of PPI treatment and GI prokinetics is more effective than PPIs alone. In this regard, access to a safe and effective prokinetic could represent a welcome adjunctive therapeutic option for patients with GERD not adequately responding to PPI therapy,” said Dr Brian E. Lacy, M.D., Ph.D., a board-certified gastroenterology specialist and Professor of Medicine in Jacksonville, FL. Dr. Lacy is the former co-Editor in Chief of the American Journal of Gastroenterology, the former Editor in Chief of Clinical and Translational Gastroenterology, and has served as the co-Chairman for the Rome IV Committee on Functional Bowel Disorders.

“With receipt of a May Proceed Letter and IND clearance, we look forward to advancing naronapride into the clinic for a second gastrointestinal indication of PPI-nrsGERD. We expect to begin enrolling patients at sites in the U.S. in a Phase 2b clinical study later this year,” said Dr. Peter Milner M.D., FACC, Chairman and CEO of Renexxion. “Our European partner is currently enrolling gastroparesis patients in an ongoing multi-center Phase 2b study of naronapride in Europe. Through these two indications, we are targeting two sizeable markets, and we look forward to developing a potential treatment for these high unmet need upper GI indications.”

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 was designed to be minimally absorbable and locally active in the gut lumen to potentially enhance efficacy and safety. Four positive Phase 2 studies have been completed and naronapride is Phase 3 ready in chronic idiopathic constipation (“CIC”) and gastro-esophageal reflux disease (“GERD”).

About Renexxion Ireland
Renexxion Ireland Limited, a wholly owned Irish subsidiary of California-based Renexxion, LLC, is a privately held biopharmaceutical company committed to delivering new drugs to patients with GI disorders. In addition to developing its lead product candidate, naronapride, Renexxion Ireland is currently advancing an additional research program in inflammatory bowel disease (“IBD”).

Further information on Renexxion Ireland can be found online: http://www.rnexltd.ie.

Investor Relations Contact:
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com
1-917-734-7387

Media Inquiries:
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