Japan Tobacco Inc. (JT) (TSE:2914) announced today the top-line results of a Phase 2 study in patients with interstitial cystitis/bladder pain syndrome in Japan for JTE-051.

This study is a double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of JTE-051 administered for 12 weeks in patients with interstitial cystitis/bladder pain syndrome. In the top-line results, JTE-051 demonstrated a statistically significant improvement in the change from baseline in Numerical Rating Scale (NRS) average bladder pain score at the end of treatment, the primary endpoint of efficacy, compared with placebo. Additionally, positive results were obtained for the secondary efficacy endpoints, including the Interstitial Cystitis Symptom Index (ICSI), voided volume and urinary frequency. In general, JTE-051 was safe and tolerable in this study.

ABOUT JTE-051
JTE-051 is a small compound expected to improve pain and inflammation by inhibiting both the nerve growth factor (NGF)- tropomyosin receptor kinase A (TrkA) signaling pathway and T cell receptor (TCR) signaling pathway via interleukin-2-inducible T-cell kinase (ITK). JTE-051 as an oral medication is expected to provide a new treatment option for interstitial cystitis/bladder pain syndrome.

ABOUT Interstitial Cystitis/Bladder Pain Syndrome
Interstitial cystitis/bladder pain syndrome is a condition with chronic pelvic pain, pressure, or discomfort perceived to be related to the urinary bladder accompanied by other urinary symptoms such as persistent urge to void or urinary frequency in the absence of confusable diseases . There are no approved oral medications for interstitial cystitis/bladder pain syndrome in Japan, highlighting the need for new oral medications that offer higher convenience.

Japan Tobacco Inc. (JT) is a global company headquartered in Tokyo, Japan. It is listed on the primary section of the Tokyo Stock Exchange (ticker: 2914.T). JT Group has approximately 53,000 employees and 62 factories worldwide, operating in three business segments: tobacco, pharmaceutical, and processed food. Within the tobacco business, the largest segment, products are sold in over 130 markets and its flagship brands include Winston, Camel, MEVIUS, and LD. The Group is committed to investing in Reduced-Risk Products and markets its heated tobacco products under its Ploom brand.
Consumers, shareholders, employees, and society are the four stakeholder groups (4S) at the heart of all of JT Group's activities. Inspired by its “Fulfilling Moments, Enriching Life” purpose, the Group aims to ensure sustainable and valuable contributions to its stakeholders over the long term. In addition to our three business segments, this goal is also supported by D-LAB, the JT Group’s corporate R&D initiative, set up to search and create added-value business opportunities. For more information, visit https://www.jt.com/.