Imbrium Therapeutics LP

MONDAY, May 22, 2023 -- Current smoking and vaping are associated with greater symptom burden among adults with cancer, according to a study published online May 22 in Cancer . Sarah N. Price, Ph.D., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues examined the association between tobacco use and symptom burden among 1,409 adult cancer survivors. The association between cigarette smoking and vaping on cancer-related symptom burden (fatigue, pain, emotional problems) and quality of life (QoL) was assessed. The researchers found that the weighted rate of cigarette smoking was 14.21 percent and the weighted rate of vaping was 2.88 percent. Current smoking was associated with greater fatigue, pain, emotional problems, and worse QoL, while current vaping was associated with greater fatigue, pain, and emotional problems, but not worse QoL. There was no association observed for higher cancer symptom burden with reduced interest in quitting, likelihood of quitting, or odds of past-year quit attempts. "Our finding that greater symptom burden was not associated with reduced interest in quitting smoking directly contradicts common assumptions that patients with cancer are resistant to tobacco cessation treatment because of their symptom burden. If smoking cessation is viewed as part of cancer symptom management, it may be more acceptable to both patients and the clinicians who treat them," Price said in a statement. "Future research should also explore whether better management of cancer symptoms like pain, fatigue, or emotional problems helps survivors quit smoking." One author disclosed ties to Imbrium Therapeutics, another to Castle Biosciences; one author has testified on behalf of plaintiffs who have filed litigation against the tobacco industry. Abstract/Full Text Posted May 2023

Multi-center, randomized study designed to evaluate safety, tolerability and pharmacokinetics of novel investigational agent STAMFORD, Conn.--(BUSINESS WIRE)-- Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), today announced the first patient first visit has been completed in the Phase 1 clinical study evaluating intravesical (into the bladder) IMB-150 (also known as LYT-503) as a potential non-opioid treatment for female patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). IMB-150, developed by PureTech applying its AlivioTM Technology Platform, is a novel formulation of lidocaine, and the clinical development program is called GainMe-IC. IMB-150 was licensed from PureTech. GainMe-IC is a clinical study program investigating use of a well-known drug, lidocaine, in a disease targeted formulation, aiming to develop a long-acting treatment that might support relief for individuals living with IC/BPS. This is a first in human, double-blind, placebo-controlled, escalating single-dose two-part study in healthy female patients and female patients with IC/BPS. An adaptive study design seeks to efficiently ascertain data needed to rapidly advance the GainME-IC program. While lidocaine has been studied for use as an intravesical treatment for IC/BPS for several decades, it has not been approved by FDA for this indication. 1,2 IC/BPS is a chronic bladder condition characterized by pain, pressure and discomfort in the bladder or pelvic region and is often associated with urinary frequency, urgency and nocturia.3 It is estimated that approximately 3-8 million women and 2 million men in the U.S. have symptoms consistent with a diagnosis of IC/BPS.4,5 However, current treatment options fail to adequately control bladder pain and other lower urinary tract symptoms in many patients. “Patients often report that the pain and other symptoms associated with IC/BPS can leave them feeling alone and isolated6, 7, 8,” said Dr. Julie Ducharme, vice president, chief scientific officer, and Public Health Initiatives co-lead. “We hope the GainMe-IC program will shed light on the ability of IMB-150 to potentially help individuals living with IC/BPS to receive targeted and sustained pain relief. GainMe-IC is an important part of our research and development efforts around non-opioid treatment options for conditions with unmet medical needs.” 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 the medication listed in this release 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 . References 1. Volpe KA, Komatsu E, Rodriguez LV, Dancz CE, Pahwa AK. The Effect of a Diagnosis on Patients With Interstitial Cystitis/Bladder Pain Syndrome: A Qualitative Approach. Female Pelvic Med Reconstr Surg. 2021;27(5):e533-e537. doi:10.1097/SPV.0000000000000985. 2. Gonzalez G, Vaculik K, Khalil C, et al. Experiences of Women with Interstitial Cystitis/Bladder Pain Syndrome: What Can We Learn From Women's Online Discussions? [published online ahead of print, 2022 Sep 8]. J Urol. 2022;101097JU0000000000002955. doi:10.1097/JU.0000000000002955. 3. Kanter G, Volpe KA, Dunivan GC, et al. Important role of physicians in addressing psychological aspects of interstitial cystitis/bladder pain syndrome (IC/BPS): a qualitative analysis. Int Urogynecol J. 2017;28(2):249-256. doi:10.1007/s00192-016-3109 4. Henry RA, Morales A, Cahill CM. Beyond a Simple Anesthetic Effect: Lidocaine in the Diagnosis and Treatment of Interstitial Cystitis/bladder Pain Syndrome. UROLOGY 2015; 85: 1025-1033. 5. Jones P, Hjelle KM, Mohn J, Guobrandsdottir G, Roth I, Chaudhry AA, Bergesen AK, Beisland C. Current Status of Intravesical Therapies for Bladder Pain Syndrome (BPS): A Narrative Review of Emerging Evidence. UROLOGY 2021; 156: e48−e57. 6. CDC. “About Interstitial Cystitis.” . Accessed November 11, 2022 7. Berry SH, Elliott MN, Suttorp M, et al. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the U.S. J Urol 2011; 186:540-4. 8. Akiyama Y, Homma Y, Maeda D (2019) Pathology and terminology of interstitial cystitis/bladder pain syndrome: a review. Histol Histopathol 34(1):25–32. MR-08200

Data demonstrate positive preliminary results for sunobinop as a potential first-in-class treatment for insomnia during recovery from alcohol use disorder* STAMFORD, Conn.--(BUSINESS WIRE)-- Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), today announced preliminary results from a Phase 2 clinical study evaluating the safety and efficacy of the novel investigational treatment sunobinop (IMB-115 / V117957) in patients experiencing insomnia during recovery from alcohol use disorder (AUD). The data were presented in a poster presentation (#76) at the 33rd Annual Meeting and Scientific Symposium of the American Academy of Addiction Psychiatry (AAAP). Sunobinop is an internally discovered oral compound being evaluated as a potential treatment for multiple disorders including insomnia during recovery from AUD. The mechanism of action is 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 and is involved in a range of biological functions including modulation of anxiety, response to stress and substance abuse.1,2 While results from clinical studies vary, the prevalence of sleep disturbances in people recovering from AUD range from 69% to as high as 91% during the early phase of withdrawal.3,4 These individuals often experience changes in sleep latency, maintenance, and architecture, characterized by more time spent in the initial stages of sleep, more awakenings, and reduced total sleep time.5 These symptoms can often persist for years following alcohol cessation5 and studies of patients with AUD have found untreated insomnia may interfere with recovery from alcohol addiction and contribute to relapse.6 “Our research program with sunobinop, and specifically results from this Phase 2 clinical study, underscore our commitment to advancing medicines that may benefit patients who are in recovery,” said Dr. Julie Ducharme, Vice President, Chief Scientific Officer. The Phase 2 randomized, double-blind, multi-center, placebo-controlled, parallel-group clinical study enrolled 114 people experiencing insomnia during recovery from AUD. Patients were randomly assigned in a 1:1:1 ratio to receive sunobinop 1 mg or 2 mg or placebo every night at bedtime for 21 days, and 89% of patients completed the study. The primary endpoint was change from baseline on wakefulness after sleep onset (WASO; or the time spent awake after falling asleep), as measured by two consecutive nights of overnight polysomnography (PSG) assessed on nights 1 and 2 and at on nights 20 and 21 of dosing. Results demonstrate both doses of sunobinop met the primary endpoint, with significant and clinically meaningful reductions in WASO, compared with placebo, that were maintained across the 3 weeks of dosing in the study. On nights 1/2, the least squares mean (LSM) difference between sunobinop 1 mg and placebo was −12.03 minutes (95% CI, −22.1 to −1.9; P=0.050), and the LSM difference between sunobinop 2 mg and placebo was −18.35 minutes (95% CI, −28.5, −8.2; P=0.003). On nights 20/21, the LSM difference between sunobinop 1 mg and placebo was −12.35 minutes (CI, −24.7 to 0.0; P=0.099), and the LSM difference between sunobinop 2 mg and placebo was −15.80 minutes (CI, −28.6, −3.0; P=0.043). Impact on sleep was also demonstrated for several secondary endpoints as measured by polysomnography while effects on subjective sleep measures collected did not reach statistical significance. Sunobinop was well tolerated across both doses. No serious adverse events were reported. One patient receiving sunobinop 2 mg discontinued due to sedation. All treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAE was somnolence (or drowsiness), which was reported in 5% of the sunobinop 1 mg group and 26% of the sunobinop 2 mg group. Baseline alcohol craving scores as assessed via the Penn Alcohol Craving Scale (PACS) were low with no increase in craving observed in any treatment group. “Currently, there are no FDA-approved products specifically indicated for insomnia during recovery from AUD. We appreciate the opportunity to present our findings at AAAP from this Phase 2 study of sunobinop in patients diagnosed with alcohol use disorder experiencing insomnia during self-reported abstinence from alcohol.” said Nelson Sessler, PharmD, lead author on the study. Sunobinop is currently in clinical development for multiple indications including, Insomnia During Recovery from AUD, Overactive Bladder and Interstitial Cystitis/Bladder Pain Syndrome. *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 . References: 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. Drug Discov. 2008;7:694–710. Wallen GR, Brooks AT, Whiting B, et al. The prevalence of sleep disturbance in alcoholics admitted for treatment: a target for chronic disease management. Fam Community Health. 2014 Oct-Dec;37(4):288-97. Kolla, B.P., Schneekloth, T., Biernacka, J., Mansukhani, M., Geske, J., Karpyak, V., Hall-Flavin, D., Louikianova, L., Frye, M.A., 2014. The course of sleep disturbances in early alcohol recovery: an observational cohort study. Am. J. Addict. 23 (1), 21–26. Brower KJ. Alcohol's effects on sleep in alcoholics. Alcohol Res Health. 2001;25(2):110-125. Brower KJ, Perron BE. Prevalence and Correlates of Withdrawal-Related Insomnia among Adults with Alcohol Dependence: Results from a National Survey. Am J Addict. 2010;19(3):238–244.