Imbrium Therapeutics Completes First Patient Visit in Phase 1 Study of Potential Treatment for Interstitial Cystitis/Bladder Pain Syndrome

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 Alivio^TM 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 isolated^{6, 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 www.imbriumthera.com.

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.” https://www.cdc.gov/ic/about/index.html. 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.

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