Bayer's P2X3 Antagonist BAY1817080 Receives First Clinical Approval in China for Refractory and Unexplained Chronic Cough

Reposted from | Medical Horizon

According to the latest public announcement by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, Bayer’s newly submitted Class 1 investigational new drug, BAY1817080, has received its first approval in China for clinical trials. The indicated indication is the treatment of refractory and/or unexplained chronic cough (RUCC). BAY1817080 is a P2X3 antagonist currently under development by Bayer, and it is in Phase II clinical development globally. Researchers consider it a potential novel therapeutic approach for chronic, refractory cough.

Screenshot source: CDE official website

As a P2X3 antagonist, BAY 1817080 demonstrated the ability to inhibit vagal depolarization in preclinical models. According to publicly available information, Bayer has completed a randomized, double-blind, placebo-controlled Phase 1/2a clinical trial in patients with chronic cough, which met its primary endpoint. Study data showed that, compared with placebo, BAY 1817080 reduced the 24-hour cough frequency in patients, and the investigational drug was well tolerated.

Query ClinicalTrials.gov information: Bayer is conducting at least four clinical trials on BAY 1817080, covering indications such as endometriosis, cough, and overactive bladder.

Image source: Bayer’s Q2 2020 Quarterly Report

According to the CDE website, this marks the first approval for clinical trials of this investigational drug in China, indicating that clinical studies for this P2X3 antagonist are expected to commence in China in the near future.

P2X3 receptors are members of the purinergic receptor family and function as non-selective ligand-gated ion channels, playing a crucial role in the generation and transmission of nociceptive signals. Recent studies have shown that overactivation of P2X3 receptors is associated with hypersensitization of sensory neurons. Airway and pulmonary neuronal hypersensitivity triggered by injury or infection can lead to excessive, persistent, and frequent coughing.

Furthermore, it is worth noting that gefapixant, another oral selective P2X3 receptor antagonist under development by Merck & Co. (MSD), achieved progress in March this year by meeting the primary efficacy endpoints in two pivotal Phase 3 clinical trials, COUGH-1 and COUGH-2, involving adult patients with refractory or unexplained chronic cough. This development has also bolstered confidence among researchers developing P2X3-targeted therapies for cough.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved July 8, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2]Safety and Efficacy of BAY 1817080, a P2X3 Receptor Antagonist, in Patients with Refractory Chronic Cough (RCC). From https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A7648

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