Imbrium Therapeutics Achieves Last Patient Last Visit in Clinical Trial of Potential Treatment for Interstitial Cystitis/Bladder Pain Syndrome
Stamford, Conn., March 11, 2025 – Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), has achieved last patient last visit in its Phase 1b study of the investigational drug sunobinop as a potential treatment for interstitial cystitis/bladder pain syndrome (IC/BPS)*. IC/BPS is a chronic painful and debilitating urologic disorder that negatively affects patients’ quality of life and can lead to radical lifestyle and behavioral modifications.1,2
Sunobinop is an investigational, novel and potential first-in-class oral compound designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein that is widely expressed in the central and peripheral nervous system3 and involved in a range of physiologic processes, including bladder voiding function as well as sensory perception of bladder pain.4,5,6,7
Forty-seven female patients with IC/BPS were enrolled in this multicenter, randomized, double-blind, placebo-controlled, crossover study. The study was designed to assess impact of once-a-day sunobinop taken at bedtime for 6 weeks on key disease symptoms, such as bladder pain and discomfort as well as urinary urgency and frequency, in subjects with IC/BPS compared to placebo.
IC/BPS has been reported to affect five times more women than men, yet the exact pathophysiology remains unclear.8 There is no cure and limited existing therapies for IC/BPS so new treatment options are needed.9
“Patients with interstitial cystitis experience very disruptive symptoms that can severely affect daily activities, work productivity, and overall quality of life. The findings from this study will help us understand sunobinop’s potential as a possible new treatment option for this chronic disorder,” said Craig Landau, MD, President and CEO of Purdue. “We look forward to reviewing and analyzing the results later this year, as we continue our commitment to innovation through research and development.”
In addition to IC/BPS, Imbrium is evaluating sunobinop as a potential treatment for overactive bladder and also for alcohol use disorder. All indications for sunobinop are open to partnering. For more information, e-mail partnering@pharma.com.
*This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop will successfully complete development or gain FDA approval.
About Imbrium Therapeutics L.P.
Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through development of important new therapeutics. We are pursuing treatments for genitourinary disorders, disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com.
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References
1. Lin KB-S, Wu M-P, Lin Y-K, et al. Lifestyle and behavioral modifications made by patients with interstitial cystitis. Sci Rep. 2021;11(1):3055.
2. Kirkham A, Swainston K. Women’s experiences of interstitial cystitis/painful bladder syndrome. West J Nurs Res. 2022;44(2):125-132.
3. Zaveri N. The nociceptin opioid receptor (NOP) as a therapeutic target: Progress in translation from preclinical research to clinical utility. J Med Chem. 2016;59(15):7011-7028.
4. Lambert D. The nociception/orphanin FQ receptor: A target with broad therapeutic potential. Nat. Rev. 2008;7(8):694-710.
5. Lazzeri M, Calò G, Spinelli M, et al. Daily intravesical instillation of 1 mg nociceptin/orphanin FQ for the control of neurogenic detrusor overactivity: A multicenter, placebo controlled, randomized exploratory study. J Urol. 2006;176(5):2098-2102.
6. Whiteside G, Auge C, Lluel P. Effects of sunobinop (V117957) in a model of acute cystitis induced by cyclophosphamide. J Urol. 2023;209(4S):e152.
7. Lazzeri M, Del Popolo G, Celso M, et al. O’Leary-Sant Questionnaire changes after intravesical administration of nociceptin/orphanin FQ (N/OFQ) in patients with interstitial cystitis/painful bladder syndrome (IC/PBS). A pilot study. J Urol. 2011;185(4S):849.
8. Bitcon C, Anderson K, Cox A. Treatment of interstitial cystitis/bladder pain syndrome: A contemporary review. EMJ Urol. 2020,5(3):91-100.
9. Hu J-C, Tzeng H-T, Lee W-C, et al. Promising experimental treatment in animal models and human studies of interstitial cystitis/bladder pain syndrome. Int J Mol Sci. 2024;25(15):8015.