Sunobinop

STAMFORD, Conn.--( BUSINESS WIRE )--Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), announced results from a Phase 1b clinical signal detection study evaluating the safety and efficacy of the novel investigational treatment sunobinop in patients with overactive bladder syndrome (OAB). OAB causes sudden urges to urinate that may be frequent and hard to control and affects 14% of men and women in the U.S. 1 Study results indicate patients experienced less need to urinate urgently, less need to urinate frequently, as well as had fewer incidents of incontinence, when comparing the sunobinop treatment period following the 2-week placebo treatment period. Across measures of micturition gathered by patient diary, the greatest effect noted was in reduction of incontinence episodes over 24 hours. During placebo treatment period, the mean number of incontinence episodes ranged from 1.0 to 1.3 (a reduction from baseline of 0.10 to 0.20). During the sunobinop treatment period the mean number of incontinence episodes ranged from 0.6 to 0.8 (a reduction from baseline of 0.3 to 0.5) and representing an additional reduction of 0.18 to 0.37 over placebo. Furthermore, reductions were observed to be greater in a subset of patients with more severe disease. Additional results from patient questionnaires that included nocturia further support an overall improvement in the condition during the sunobinop treatment period. 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 system 2 and involved in a range of biological functions. 3,4 “Millions of people in the United States struggle with OAB, which can have a negative effect on patients’ daily activities. New treatment options are needed for OAB patients,” said Craig Landau, MD, President and CEO of Purdue. “We are encouraged that sunobinop produced a signal in this population and look forward to confirming these positive findings in additional clinical studies.” Fifty-one female patients suffering from OAB were enrolled in this multicenter, randomized, double-blind, placebo-controlled single sequence crossover study. The study tested the effects of sunobinop given at bedtime on key disease symptoms, such as urinary urgency, frequency, incontinence, and nocturia as compared to placebo. Patients initially received 2 weeks of single blind placebo followed by 2 weeks of double-blind placebo. Patients were then switched in a blinded fashion to 1 mg of sunobinop, which was taken nightly for 6 weeks. The study also included a final week on placebo. This dosing duration constitutes the longest patient exposure to sunobinop in a clinical study to date. No serious adverse events were reported. No patients discontinued treatment due to adverse events. The most common adverse event observed in the study was urinary tract infection. “These are exciting results with a novel treatment approach that includes consideration of nighttime symptoms such as nocturia,” said Roger R. Dmochowski, MD, MS, MMHC, FACS, an internationally recognized urologist, surgeon, and leading researcher in functional bladder disorders, who assisted in the study design and evaluation of the results. “With it’s unique mechanism of action, sunobinop is the first oral agent that blocks the sensory impulses that trigger patients’ bladder symptoms.” In addition to OAB, Imbrium is also evaluating sunobinop as a potential treatment for interstitial cystitis/bladder pain syndrome (IC/BPS) and separately for alcohol use disorder. All indications for sunobinop are open to partnering. For more information, e-mail partnering@pharma.com . This press 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 the development of important new pharmacologic and biologic therapeutics. We are pursuing oncology chemotherapeutics, treatments for disorders of the central nervous system, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market 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 actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com . References: Reynolds, W., Fowke, J., & Dmochowski, R. The burden of overactive bladder on US public health. Current Bladder Dysfunct Rep. 2016;11(1):8–13 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. Lambert, D. The nociception/orphanin FQ receptor: a target with broad therapeutic potential. Nat. Rev. 2008;7(8):694-710. 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):2098-102.