Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride
ROSCREA, Ireland, Nov. 30, 2023 - 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 [email protected], or on 1-917-734-7387
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 [email protected], or on 1-917-734-7387