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    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
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Renexxion Achieves Positive FDA Guidance for Phase 3 ready GI Drug Naronapride

​Cardiovascular outcome safety study requirement dropped, limited trials required for NDA filing
​Menlo Park, California – November 16, 2016 - Renexxion today announced positive guidance on the design of the final pivotal trials required for NDA filing for naronapride, a potentially best-in-class 5HT-4 agonist for treatment of GI motility disorders. 
​
At a recent meeting of the FDA’s Division of Gastroenterology and Inborn Errors Products (DGIEP), and the Center for Drug Evaluation and Research’s (CDER) new Safety Outcomes Trials (SOT) Subcommittee, it was agreed that the necessary safety database for naronapride development for chronic idiopathic constipation (CIC) and other functional GI disorders does not require statistical powering for cardiovascular outcomes. Furthermore, Renexxion was advised that two randomized, blinded placebo-controlled clinical trials of 1000 subjects each of 12 weeks duration in this indication would be sufficient for filing of an NDA for naronapride.  The safety trials would be limited to 12 months total exposure in these 2000 subjects in addition to the 982 subjects already exposed in the four positive Phase II studies.
  
Peter Milner M.D., CEO, said “As a result of cooperative interactions between Renexxion management and the FDA, the agency formally dropped its requirement for preapproval CV safety outcome studies so that there is now a clear pathway to approval in CIC, the largest functional GI market.  By agreement with the FDA, the additional 2000 total further exposures in two randomized clinical trials would be NDA-enabling. This path to approval is consistent with some of the other recently approved drugs in constipation indications and is familiar to large pharmaceutical companies.”

About GI motility disorders
GI motility disorders encompass a wide range of disorders of the esophagus, the stomach, the small and large intestines.  Disorders associated with these organs include chronic idiopathic constipation (CIC), gastroesophageal reflux disease (GERD) especially those forms resistant to treatment with a proton pump inhibitor (PPI), delayed gastric emptying – gastroparesis (GP), and constipation due to irritable bowel syndrome (IBSc). Such disorders may be primary or associated with other diseases such as diabetes, or Parkinson’s Syndrome.  Cisapride (Propulsid®) and tegaserod (Zelnorm®), the two most successful motility agents, each sold over $1B annually, but were withdrawn over 10 years ago due to unexpected cardiac safety concerns discovered after marketing; since then no safe and effective motility agent has been approved.

About naronapride  
Naronapride is a new generation of potentially best-in-class 5HT-4 agonist that stimulates gastrointestinal motility. Naronapride was engineered to avoid any risk of cardiac arrhythmia seen in the older agents in this drug class, such as cisapride and tegaserod, and to reduce undesirable off-target pharmacological effects. In addition to the chronic oral formulation enabled by the recent FDA interaction, an intravenous formulation (or single use oral solution formulation) can be developed for the growing and important unmet needs in ICU and ventilator units of enteral feeding intolerance (EFI), acute GP, short bowel syndrome (SBS) and post operative ileus (POI). Today there are currently no FDA-approved treatment options available and these indications impact several millions of Americans with EFI alone affecting one million Americans.

About Renexxion
Renexxion, LLC is a privately held biopharmaceutical company committed to delivering benefits to patients with GI motility disorders by developing naronapride to approval and to becoming a leading GI biopharmaceutical company. www.renexxion.com

Contact: 
 1-650-924-9895/1-650-376-0598 
[email protected]
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  • Home
  • Company
    • Our Vision
    • Our Leadership Team
  • ​Naronapride (ATI-7505)
    • About Naronapride (ATI-7505)
    • Mechanism of Action
    • Development Status
    • Chemistry and Manufacturing
    • Regulatory Developments
  • Knowledge Centre
    • Gastrointestinal Dysmotility in Cystic Fibrosis (CF)
    • Gastroparesis
    • Chronic Idiopathic Constipation
    • Irritable Bowel Syndrome
    • PPI non-responsive GERD
  • News
    • Press >
      • ​Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Completion of Enrollment of the Global Phase 2b Study Evaluating Naronapride in Gastroparesis (MOVE-IT)
      • Renexxion Ireland Ltd. Announces Issuance of Fifth New U.S. Patent Covering Novel Crystal Isoform of Naronapride
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Expansion of the Phase 2b MOVE-IT Study of Naronapride in Gastroparesis and Dosing of the First United States Patient
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
      • Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories
      • Renexxion to Present at the Oppenheimer 34ᵗʰ Annual Healthcare Life Sciences Conference
      • Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
      • Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD
      • Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
      • ​Renexxion to Present at the Oppenheimer Healthcare Private Company Showcase​
      • Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce Initiation of Phase II Study of naronapride in patients with gastroparesis
      • Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
      • Gastrointestinal Biotech Company Renexxion Ireland Announces $100M Investment Commitment
      • Renexxion Ireland Announces Issuance of a New US Patent covering Naronapride, a Clinical Stage Potential Best-in-Class Prokinetic Agent for Gastrointestinal Disorders
      • Renexxion Ireland Ltd. Announces a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH
  • Contact