Bayer's Investigational P2X3 Antagonist BAY 1817080 Granted Clinical Trial Approval in China for Endometriosis

According to the public information from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, Bayer's Class 1 new drug, BAY 1817080 tablets, has received implicit approval for two clinical trials, targeting endometriosis. Publicly available data shows that BAY 1817080 is an investigational P2X3 antagonist and has not yet been approved for marketing in any country or region.

Source of screenshot: CDE official website

Endometriosis refers to the presence of endometrial tissue with growth potential in locations outside the uterine cavity. It is a common gynecological disorder that severely impacts women’s physical and mental health as well as their quality of life. Infertility and pain are the primary clinical manifestations of endometriosis. Recent studies have revealed an abnormal distribution of sensory nerve fibers and high expression of specific nociceptive receptors within endometriotic lesions, and these phenomena are correlated with patients’ pain symptoms.

Adenosine triphosphate (ATP) is the most important energy and signaling molecule within cells. Under both physiological and pathological conditions, ATP and other nucleotide analogs can be secreted by various cells, acting on receptors widely distributed across organs and tissues throughout the body. Among these, the P2X3 receptor is a member of the purinergic receptor family and functions as a non-selective ligand-gated ion channel. Studies have shown that P2X3 receptors are specifically expressed in epithelial cells and sensory neurons, and their overexpression and activation can lead to pain sensitization in animal models of chronic pain. This indicates that the P2X3 receptor plays a crucial role in the sensitization and signal transmission associated with neuropathic pain.

BAY 1817080 is an investigational P2X3 antagonist being developed by Bayer for the treatment of multiple indications, including endometriosis, chronic cough, and overactive bladder. In September 2020, BAY 1817080 was approved in China to conduct clinical studies for “refractory and/or unexplained chronic cough (RUCC).” The recent approval of this product for clinical trials in endometriosis signifies that the therapeutic indications under investigation for BAY 1817080 in China are continuously expanding.

Currently, BAY 1817080 has achieved positive results in studies treating patients with chronic cough. Data from a Phase 1/2a clinical study showed that, compared with placebo, BAY 1817080 reduced the number of coughs over 24 hours in patients, and the investigational drug was well tolerated. According to information on the ClinicalTrials.gov website, Bayer is also exploring the efficacy of BAY 1817080 in the treatment of endometriosis in multiple trials.

Congratulations on the approval of Bayer’s P2X3 antagonist BAY 1817080 tablets for clinical trials in China. We look forward to the smooth progress of subsequent research and the early availability of this new treatment option for patients.

▽Follow [WuXi AppTecBayer】WeChat Official Account