IC/BPS and its associated pain significantly affects quality of life, including loss of work, and is associated with suicidal rates five-to-seven times the national average.
RAANANA, Israel, July 22, 2021 (GLOBE NEWSWIRE) -- Trigone Pharma Ltd., a privately owned biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from urological diseases that have a significant unmet need, announces the oral presentation of data from the pharmacokinetic data and animal study results data for TRG-100 in swine at the American Urological Association (AUA) in September 2021.
“The performance of TRG-100 animal model is potentially an exciting development for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS),” said Boris Chertin, M.D., Professor, Chairman of The Department of Urology, Shaare Zedek Medical Center, Jerusalem, and lead investigator for the planned Phase IIa clinical trial. “The current data is very encouraging demonstrating that TRG-100 can deliver Oxybutynin and Lidocaine in a sustained release manner into the bladder over a two-week period, posing a potential novel therapy for IC/BPS patients who suffer from chronic pain which significantly impacts their quality of life. Plasma concentrations of Oxybutynin and Lidocaine administered intravesical in swine, were uniformly adequate and stable over the 7 days study period of the study, with almost undetectable concentration of a harmful metabolite N-desethyloxybutynin (NDO), indicating how safe and effective the TRG-100 can be in the clinical settings. IC/BPS and its associated pain significantly affects quality of life, including loss of work, and is associated with suicidal rates five-to-seven times the national average. It is also associated with other major morbidities and lacks any effective treatment.”
“The in-vitro and animal data suggest that TRG-100 can safely be used for possible intravesical sustained release of Lidocaine and Oxybutynin in the treatment of BPS/IC. Our preliminary results should be further confirmed in the upcoming Phase IIa trial,” said Dan Touitou, Chief Executive Officer of Trigone Pharma. “The data has also prompted us to evaluate the safety and efficacy in overactive bladder and renal colic patients. We look forward to engaging with the FDA in the coming months on these datasets.”
Interstitial Cystitis/Bladder pain syndrome (IC/BPS) is a chronic debilitating condition of unknown etiology. Intravesical lidocaine administration has demonstrated pain relief in patients with IC/BPS. Intravesical administration of Oxybutynin has a well-documented therapeutic effect in patients with urinary bladder disorders due to a direct local anesthetic, antimuscarinic and spasmolytic effect within the bladder wall. However, the current intravesical use of the both drugs in clinical practice does not provide an adequate treatment solution due to rapid dilution and loss of drug with urination requiring multiple administrations. The ability to prolong drug retention in the urinary bladder enhances the bladder wall tissue exposure to adequate therapeutic level of drugs.
About Trigone Pharma
Trigone Pharma is aiming to restore the quality of life for patients suffering from bladder diseases that affect populations with unmet medical needs. Our proprietary technology enables generating transformative therapeutics across a variety of diseases that currently affect millions of people.
Our lead program TRG-100 is a novel proprietary long-acting anti-pain and urinary urgency treatment combing two medicines for intravesical treatment of IC/BPS, a chronic urinary bladder condition that causes severe bladder pain. Our localized therapy acts continuously over weeks, a revolution in the field of urology. TRG-100 has been found safe in GLP repeated toxicology study and effective in delivering active compounds for prolonged periods.
Our pipeline includes new treatments for overactive bladder, renal colic as well as bladder cancer. TRG-100 is subject to an expedited regulatory pathway for approval by the FDA. The company is gearing up to the initiation of the phase IIa clinical trial in IC/BPS patients.