Study progresses of oral compound for overactive bladder

The final patient visit has been conducted in a phase 1b study (NCT06024642) evaluating the investigational oral agent V117957 (sunobinop) in patients with overactive bladder (OAB) syndrome, announced Imbrium Therapeutics, a subsidiary of Purdue Pharma and the developer of the compound, in a news release.¹

V117957 is also being evaluated in a phase 1 study for patients with interstitial cystitis/bladder pain syndrome.

“Millions of patients with overactive bladder are in need of additional treatment options for the disruptive, distressing symptoms,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer of Purdue Pharma, in the news release.¹ This study will help us learn more about sunobinop’s potential to be a new treatment option. We look forward to reviewing and analyzing the results later this year.”

In total, the phase 1b, multicenter, double-blind, placebo-controlled crossover trial enrolled 51 female patients with OAB to assess the safety, tolerability, and preliminary efficacy of V117957 in this patient population.² Those enrolled in the study were randomly assigned to receive 1 tablet of V117957 taken orally at bedtime or to a matched placebo tablet.

The primary end points for the study are the change from baseline in the number of micturition episodes and the number of incontinence episodes in 24 hours as well as the change from baseline in the volume voided per 24 hours, as assessed at baseline and weeks 2, 4, 6, 8, and 9. Secondary outcome measures include the change from baseline in scores on the Patient Perception of Bladder Condition questionnaire, Overactive Bladder Questionnaire: Long-Form, 1-week Recall, Subject Global Response Assessment, Patient Perception of Intensity of Urgency Scale, and the Symptom Impact Sleep Questionnaire.

Participants were eligible for enrollment in the trial if they were female, aged 18 to 70 years, capable of voiding independently, able to comply with acceptable methods of contraception, had symptoms of OAB––including urinary urgency and urinary frequency with incontinence for 3 or more months––and were willing to modify current treatment regimen for OAB.

Patients were excluded from the study if they had stress incontinence or mixed stress/urge incontinence with stress as the predominant factor, hematuria associated with bladder malignancy, bladder hydrodistension within the past 6 months, a urinary tract infection (UTI) within the past 30 days or a history of recurrent UTI, grade 3/4 pelvic organ prolapse, or clinically significant kidney disease or nephrolithiasis. Additionally, patients could not have received a surgical procedure that affected bladder function or intravesical therapy within the 12 months prior to study entry.²

Craig Landau, MD, president and CEO of Purdue Pharma, added in the news release, “We are pleased to achieve last patient last visit in the sunobinop phase 1b study. Our continued progress in this work demonstrates our ongoing commitment to innovation through research and development.”¹

In addition to the study in patients with OAB, V117957 is also being evaluated in a phase 1 study (NCT06285214) for patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The first patient visit in the trial was reported in December 2022.³

In total, the multicenter, randomized, double-blind, placebo-controlled, crossover trial plans to enroll 44 adult female patients with IC/BPS across clinical trial sites in the US. Patients included in the study will be randomly assigned to receive 1 tablet of V117957 orally at bedtime or to a matched placebo tablet. The primary end point for the study is the change from baseline in bladder pain/discomfort scores per 12 hours.

Final study completion is anticipated for June 2026.⁴

References

1. Imbrium Therapeutics achieves last patient last visit in clinical trial of potential treatment for overactive bladder syndrome. News release. Imbrium Therapeutics. Published online and accessed July 9, 2024. https://www.imbriumthera.com/news/imbrium-therapeutics-achieves-last-patient-last-visit-in-clinical-trial-of-potential-treatment-for-overactive-bladder-syndrome/

2. Study of V117957 in overactive bladder syndrome. ClincialTrials.gov. Last updated June 21, 2024. Accessed July 9, 2024. https://clinicaltrials.gov/study/NCT06024642

3. Imbrium therapeutics completes first patient visit in phase 1 study of potential treatment for interstitial cystitis/bladder pain syndrome. News release. Inbrium Therapeutics. December 20, 2022. Accessed July 9, 2024. https://www.imbriumthera.com/news/imbrium-therapeutics-completes-first-patient-visit-in-phase-1-study-of-potential-treatment-for-interstitial-cystitis-bladder-pain-syndrome/

4. Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome. ClincialTrials.gov. Last updated June 3, 2024. Accessed July 9, 2024. https://clinicaltrials.gov/study/NCT06285214