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Today (November 11), Hansoh Pharma announced that its self-developedOnce-daily oral P2X3 antagonistHS-10383 for the Treatment of Chronic CoughThe Phase 1 clinical trial achieved positive results, which were presented at the Asia-Pacific Respiratory Society Conference (APSR 2024) held in Hong Kong, China, from November 7 to 10.Phase 1 clinical trial shows that HS-10383 is generally well-tolerated with a long half-life, supporting once-daily oral administration.
Refractory or Unexplained Chronic Cough (RUCC) is a distressing condition characterized by a persistent, stubborn cough lasting more than eight weeks, significantly impacting the patient's quality of life. In addition to causing discomfort, these symptoms may lead to severe physical and mental health effects, such as fatigue, sleep disorders, urinary incontinence, social embarrassment, and even depression or anxiety. Epidemiological data in China show that chronic cough accounts for approximately 30% of cases in respiratory outpatient clinics, including a considerable proportion of RUCC.[2,3]However, currently, there are limited effective treatment options for RUCC, and existing therapies mainly focus on symptom management. Although new advances in targeted treatments have shown potential to improve patient outcomes, many patients still lack long-term treatment solutions.P2X3 receptor, a member of the purinergic receptor family, is a non-selective ligand-gated ion channel.Recent studies have found that the overactivation of P2X3 receptors is associated with the hypersensitization of sensory neurons, and that airway and lung neuron hypersensitivity triggered by injury or infection can lead to excessive, persistent, and frequent coughing. ThereforeP2X3Considered an important target for the treatment of RUCC.HS-10383 is a proprietary product independently developed by Hansoh Pharma.Highly Selective P2X3 Receptor Antagonist, is being developed for the treatment of RUCC. According to a press release from Hansoh Pharma,This product is expected to effectively reduce the frequency of coughing with minimal impact on taste function, thereby offering patients better efficacy and treatment adherence.To evaluate the safety, tolerability, and pharmacokinetic profile of HS-10383, this study assessed 36 subjects who had received at least one treatment, distributed across three dose groups. In each dose group, 12 subjects were randomly assigned to receive either HS-10383 or a placebo in a 3:1 ratio, administered once daily for seven consecutive days. HS-10383 was generally well-tolerated, with all adverse events being mild to moderate. Notably,No adverse events (AEs) related to taste disorders were observed, and no treatment-emergent adverse events (TEAEs) led to treatment discontinuation.。Pharmacokinetic characteristics show that HS-10383 has a terminal half-life of 35 to 48 hours, supporting once-daily oral administration.。 CurrentlyHS-10383A Phase 2, randomized, double-blind, placebo-controlled, parallel-design study is ongoing to evaluate the efficacy, safety, and tolerability of HS-10383 administered orally once daily at different dose levels.
References:
[1]APSR 2024 | Hansoh Pharma's Once-Daily Oral P2X3 Antagonist HS-10383 Achieves Positive Results in Phase I Clinical Trial for Chronic Cough. Retrieved Nov 11, 2024, from https://mp.weixin.qq.com/s/GNqF5ogmHZ53IPOfJs8SQA
[2]Gao, Z., Xu, Y., Zhang, X., Yang, J., Wang, Z., & Jiang, S. (2019). Prevalence and characteristics of chronic cough in the general population in Guangzhou, southern China. Respiratory Medicine, 155, 43-48.
[3]Xu, Y., Zhang, X., Lin, J., & Chen, Q. (2018). Clinical characteristics and potential predictors for chronic cough in Chinese patients. Journal of Thoracic Disease, 10(1), 123-130.
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