- Generally well-tolerated with a long half-life supporting once-daily oral administration.
- No taste disorder related AEs and TEAEs leading to treatment discontinuation.
- A dose optimization Phase II study ongoing to inform the registration enabling studies.
SHANGHAI, November 11, 2024 — Hansoh Pharma (03692.HK) announces that the positive topline clinical results from Phase I multiple dose-ascending (MAD) study of HS-10383, a highly selective P2X3 antagonist, in healthy Chinese subjects will be presented at the Asian Pacific Society of Respirology conference in Hong Kong, from November 7 to 10.
A total of 36 participants receiving at least one dose of treatment were enrolled across three cohorts to evaluate the safety, tolerability, and pharmacokinetics of HS-10383. In each cohort, 12 participants were randomly assigned in a 3:1 ratio to receive either HS-10383 or a placebo once daily for a period of 7 days. HS-10383 was generally well-tolerated, with all adverse events reported as mild to moderate. Importantly, no adverse events related to taste disturbance were observed, nor were there any treatment-emergent adverse events (TEAEs) that led to discontinuation. HS-10383 displayed a terminal half-life of 35-48 hours, supporting its potential for once-daily oral administration1.
The program is currently undergoing a randomized, double-blind, placebo-controlled and parallel-designed Phase 2 study, to assess the efficacy, safety and tolerability of HS-10383, at different doses administered orally, once-daily (CTR20240165; NCT06246565).
Refractory or unexplained chronic cough (RUCC) are debilitating conditions defined by a persistent cough lasting more than eight weeks, which significantly diminishes patients’ quality of life. Beyond discomfort, these conditions can lead to serious physical and psychological impacts, such as fatigue, disturbed sleep, urinary incontinence, social embarrassment, and even depression or anxiety. Epidemiological data from China indicate that chronic cough contributes to approximately 30% of respiratory cases, including a substantial proportion of RUCC 2,3. Unfortunately, effective treatment options for RUCC are limited, with current approaches mainly focused on symptom management. Recent advances in targeted therapies, though promising, are still emerging, leaving many patients without a long-term solution.
"In light of the significant unmet needs in treating chronic cough, the development of the investigational P2X3 receptor antagonist represents a promising step forward.," said Ms. Eliza Sun, Executive Director of Board, "With its highly selective inhibition of the P2X3 receptor, our drug candidate HS-10383 has unique structure aiming to reduce coughing episodes while minimizing the impact on taste function. This program may offer hope for a more effective and well-tolerated therapy for patients suffering from chronic cough."
About HS-10383
HS-10383 is a highly selective P2X3 receptor antagonist, developed for RUCC, and other potential indications. The P2X3 receptor plays a crucial role in the cough reflex pathway and has been identified as an important target for addressing RUCC, a condition that significantly impacts patients' quality of life. Various clinical trials have investigated P2X3 receptor antagonists as potential treatments, showing promise in reducing cough frequency. The company believes its highly selective P2X3 antagonist offers a distinct advantage by effectively reducing cough frequency while having a minimal impact on taste. This balance between efficacy and tolerability may contribute to improved patient outcomes and greater adherence to therapy.
Reference:
1. Li, Q., Chen, K., Zhang, Y., Zhou, H., Ye, P., Song, L., Zhao, F., Shi, J., Wu, Q., Zhang, J., Jia, W., Kong, K., Tao, Y., Yang, X., & Zhao, W. (2024). Safety, tolerability, and pharmacokinetics of HS-10383 in healthy subjects: A randomized, double-blind, placebo-controlled, and multiple dose-ascending phase I trial. Abstract presented at the 2024 Congress of the Asian Pacific Society of Respirology (APSR), Hong Kong, China. Abstract 1302.
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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