Proton pump x D2 receptor

Feb. 07, 2024 -- Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, announced today that its European Partner, Dr. Falk Pharma GmbH (“Dr. Falk Pharma”), has elected to advance the development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD) as the second indication in their licensed territories. This marks an expansion of a pre-existing partnership that also encompasses the evaluation of naronapride for gastroparesis, which is currently undergoing a Phase 2b trial in Europe. In October 2021, Renexxion and Dr. Falk Pharma announced an exclusive Licensing and Collaboration Agreement to advance naronapride initially for gastroparesis in Greater Europe (including UK), Russia, Central Asian Republics, and certain Australasian countries. Today, Renexxion is pleased to confirm that Dr. Falk Pharma will also advance naronapride for PPI-non-responsive symptomatic GERD in these regions. Renexxion will receive undisclosed development and commercial milestones related to this expanded collaboration. GERD is a prevalent disease affecting between 10-20% of Europeans. Up to 30-40% of patients do not achieve adequate control with PPIs and there is a high unmet need for an adjunctive therapy to achieve greater symptom control. Naronapride is a late-stage potential best-in-class oral, locally acting pan-GI, dual-action 5-HT4 agonist/D2 antagonist prokinetic that is in development as an adjunctive therapy for GERD patients who fail to respond adequately to acid-suppression treatments. Renexxion recently received IND clearance from the U.S. Food and Drug Administration (FDA) for the development of naronapride for patients with PPI-non-responsive symptomatic GERD and plans to begin a U.S. Phase 2b trial in this condition later in 2024. “Approximately one-third of GERD patients continue to suffer from heartburn and regurgitation despite using PPIs. It's becoming increasingly clear that GI dysmotility may be a significant contributor to the persistence of these symptoms. Combining PPIs with 5-HT4 prokinetics has shown greater effectiveness than PPIs alone. However, many marketed prokinetics are not safe to use long-term and do not provide significant benefit. Access to a safe and effective prokinetic could be a valuable adjunctive therapeutic option for PPI-nrsGERD patients.” said Professor Ahmed Madisch M.D., Center of Gastroenterology Bethany, Agaplesion Hospital Bethany, Frankfurt, Germany. Kai Pinkernell, Ph.D., Managing Director, Science & Innovation at Dr. Falk Pharma added “We believe naronapride has great potential to benefit patients with a wide variety of medical conditions arising from impaired GI motility. As the partner in Europe and Australasia, we are excited to be joining Renexxion in developing naronapride for PPI-non-responsive symptomatic GERD, as we see the positive impact naronapride can bring to this large population of patients. This is a welcomed addition to our pipeline which includes naronapride for gastroparesis.” “We are very pleased that our European partner, Dr. Falk Pharma, chose PPI-nrsGERD as its next indication for development for naronapride in their territories. This partnership is pivotal to our mission, as it aims to expand access for the substantial segment of GI patients who are currently underserved by existing treatment options,” said Peter Milner M.D., FACC, Chairman and CEO of Renexxion. 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”). 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”). Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepato-biliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre-clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well-being. A family-owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy, and Switzerland. The Falk Group employs approximately 1250 individuals globally, thereof 294 in Freiburg. The content above comes from the network. if any infringement, please contact us to modify.

ROSCREA, Ireland, Dec. 20, 2023 (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, announced today that it has completed a successful pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (U.S. FDA) to discuss development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). PPI-nrsGERD affects over 20 million patients in the U.S., and current treatments are focused solely on the mechanism of acid suppression without addressing gastrointestinal (GI) motility. Naronapride, Renexxion’s lead drug candidate, is a potential best-in-class oral, locally acting pan-GI prokinetic, which works by modulating two validated targets, 5-HT4 receptor agonism and D2 receptor antagonism, with a well-differentiated pharmaceutical, pharmacokinetics, safety, and efficacy profile from other 5-HT4 agonists. “As many patients with GERD do not adequately respond to PPI, the potential use of prokinetic therapy may represent a plausible pathophysiologic target for some patients, as when gastroparesis symptoms co-exist. However, commercially available prokinetics have not clearly demonstrated clinical benefit in the absence of gastroparesis. In this context, potential access to a safe and effective prokinetic could represent a welcome adjunctive therapeutic option for selected patients with GERD not adequately responding to PPI therapy,” said Dr. Amit Patel, MD, Gastroenterologist and Associate Professor of Medicine at Duke University. The main purpose of the pre-IND consultation was to discuss key considerations related to indication, endpoints, clinical study design, development plan, and necessary data, to open an IND investigating naronapride in patients with PPI-nrsGERD. Renexxion is encouraged by the feedback from the Agency on submitted questions, as well as its acceptance of the potential for PPI-nrsGERD as a new indication for naronapride. “Naronapride is a potential best-in-class pan-GI prokinetic which is currently in a multi-center Phase 2b study in patients with gastroparesis. It has completed four Phase 2 studies in related GI indications including as monotherapy in newly diagnosed GERD. With the recent feedback from the U.S. FDA our Company will pursue IND clearance to develop naronapride for an underserved new indication, PPI-nrsGERD,” said Peter Milner M.D., FACC, Chairman and CEO of Renexxion. “We look forward to collaborating with the Agency to demonstrate naronapride is both safe and effective for PPI-nrsGERD.” 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. 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 (“IBD”). For information: http://www.rnexltd.ie. Investor Relations Contact:Irina Koffler, LifeSci Advisors, at ikoffler@lifesciadvisors.com, or on 1-917-734-7387

ROSCREA, Ireland, Nov. 30, 2023 (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, announced today that the United States Patent Office (“USPTO”) has issued a new composition of matter patent (Patent no. 11,643,409) and a method of use patent (Patent no. 11,827,631), both covering a novel crystal isoform of naronapride. The composition of matter patent is the third new patent issued by the USPTO covering naronapride, a potential best-in-class oral, locally acting pan-GI prokinetic, which works by modulating two validated targets, 5-HT4 receptor agonism and D2 receptor antagonism, with a well-differentiated pharmaceutical, pharmacokinetics, safety and efficacy profile from other 5-HT4 agonists. Naronapride is Renexxion’s lead drug candidate in mid-stage clinical development for gastroparesis and proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (“PPI-nrsGERD”), two high unmet need indications with limited or no currently available treatments. The new patents are currently being prosecuted worldwide including EP, Japan, and Greater China. “The issuance of these new patents is an important milestone for the naronapride program and demonstrates our commitment to advancing this compound and making it widely accessible as a treatment for chronic GI diseases in large patient populations,” said Peter Milner M.D., FACC, Chairman and CEO of Renexxion. “We are pleased with naronapride’s development to date and continue to be excited about its potential to address unmet need for patients living with GI disorders requiring a prokinetic for use in upper or lower GI conditions.” The current naronapride patent estate includes composition of matter, method of use and formulation patents. Renexxion is currently prosecuting these patents in EP, Japan, and greater China. 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-II studies have been completed and naronapride is Phase-III ready in chronic idiopathic constipation (“CIC”), currently in Phase II-b study in gastroparesis, and Phase II-b ready in PPI-nrsGERD. 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. 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 (“IBD”). For information: http://www.rnexltd.ie. Investor Relations Contact:Irina Koffler, LifeSci Advisors, at ikoffler@lifesciadvisors.com, or on 1-917-734-7387