Trigone Pharma Announces the Initiation of a Phase 2 Clinical Trial of TRG-100 in Patients with Interstitial Cystitis/Bladder Pain Syndrome

TRG-100 is now being evaluated in broad range of bladder disorders

RAANANA, Israel, Aug. 13, 2021 (GLOBE NEWSWIRE) — Trigone Pharma Ltd. a leader in the field of urological diseases, today announced the initiation of a Phase 2 study of TRG-100 in patients with interstitial cystitis/ bladder pain syndrome (IC/BPS). The study will enroll patients who have recurred or progressed following standard therapy or have not responded to prior standard therapy.

Preclinical studies have demonstrated that TRG-100 is able to slowly release Oxybutynin and Lidocaine in the bladder over a period of two-week, thus posing a potential novel therapy for IC/BPS patients who suffer from chronic pain which significantly impacts their qualitfy of life. Plasma concentrations of Oxybutynin and Lidocaine administered intravesically in swine, were uniformly high and stable over the seven-day study period with almost undetectable concentration of the adverse metabolite – N-desethyloxybutynin (NDO), alluding to the potential safety and efficacy of TRG-100 in the clinical settings. IC/BPS and its associated pain significantly impacts the quality of life of these patients, and includes loss of work and is associated with suicidal rates five-to-seven times the national average, withmajor morbidities and luck of effective treatment.

“Evaluating TRG-100 in patients with interstitial cystitis is an important next step in our efforts to establish the potential of this novel therapy to treat a broad range of bladder disorders with unmet medical needs,” said Boris Chertin, M.D., Professor, Chairman of The Department of Urology, Shaare Zedek Medical Center, Jerusalem, and lead investigator in the Phase 2 clinical trial. “The safety, pharmacokinetics and mode of action we have observed from the various dose levels studied provide us with insights of the potential to provide long and sustainable pain relief as well as dramatic improvement on the patients’ quality of life. TRG-100 will only be evaluated in IC/BPS patients diagnosed according to the American Urological Association endorsed criteria with ≥ 6 weeks duration of bladder pain/discomfort symptoms before enrollment, and at least 6 weeks duration of one accompanying lower urinary tract symptom, such as pain, urinary frequency, urgency or nocturia, with negative urinary culture. Symptoms and diagnostic work-up will be in accordance with AUA IC/BPS guidelines.”

About the Phase 2 Trial

The Phase 2, open-label, clinical trial of TRG-100conducted by Trigone Pharma, is designed to assess the clinical activity, safety and tolerability of TRG-100 among patients with interstitial cystitis. TRG-100 will be given as a single agent and will be administered intravesically into the bladder at an initial regimen of once a week, for 28 days. Key objectives of the trial include safety, pharmacokinetic, and pharmacodynamics evaluation, and characterizing the clinical activity of TRG-100. The Phase 2 trial is expected to include a dose expansion phase where patients with IC/BPS will receive the TRG-100 treatment bi-weekly for two additional months to further evaluate safety, tolerability and clinical activity.

About TRG-100

Trigone Pharma is developing TRG-100, a long acting intravesical anti-pain and anti-cholinergic local therapy for treating IC/BPS, using a novel liquid drug delivery system which forms a soft solid mass in the bladder when the formulation comes in contact with the urine inside the bladder. TRG-100 is a proprietary combination drug administered directly into the bladder, designed to locally treat the chronic pain and the complexity of IC/BPS rapidly, to improve patients’ quality of life. It is designed to rapidly onset pain relief and diminish urinary urgency and pain.

Interstitial Cystitis/Bladder Pain Syndrome

The chronic urological pain associated with Interstitial Cystitis / Bladder pain syndrome (IC/BPS) remains the highest unmet need in the urology field. Approximately 8% of men experience some degree of chronic pelvic or genitourinary pain over the course of a year. A similar or greater number of women experience pelvic and/or bladder pain of urologic origin. For at least a third of these individuals, the pain is moderate to severe, bothersome, and impacts their daily activities and quality of life, including sleep and sexual dysfunction. For some patients, the pain and associated symptoms can be totally disabling. For others, suicidal ideation becomes a possible way out of their misery.

Trigone Pharma Ltd.

Trigone Pharma Ltd., a clinical-stage biopharmaceutical company based in Israel, is dedicated to developing and commercializing novel therapeutics to treat patients suffering from interstitial cystitis/ bladder pain syndrome (IC/BPS), Bladder Cancer (NMIBC), and other related bladder conditions.

CONTACT:

Dan.T@TrigonePharma.com