Hansoh Pharma Announces Positive Phase I Results for Once-Daily Oral P2X3 Antagonist HS-10383 in Chronic Cough at APSR 2024

Nov 12, 2024 08:31 CST Updated 08:31

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Phase Ⅰ clinical trial showed that HS-10383 was generally well-tolerated with a half-lifeLong,Supports once-daily oral administration¹。

No adverse events (AEs) related to taste disorders, and no treatment-emergent adverse events (TEAEs) leading to treatment discontinuation.¹。

The ongoing Phase II clinical trial for dose optimization aims to provide a basis for dose selection in registration clinical studies.

January 2024January 11Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma, 03692.HK), a leading innovation-driven pharmaceutical company in China, announced that the positive results of the Phase Ib multi-dose study of HS-10383, a highly selective P2X3 antagonist independently developed by the company, conducted in Chinese healthy subjects, were presented at the Asia-Pacific Society of Respirology Conference (APSR 2024) held in Hong Kong from November 7 to 10.¹。

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 (AEs) being mild to moderate. Notably, no taste disturbance-related AEs were observed, and no treatment-emergent adverse events (TEAEs) led to treatment discontinuation. Pharmacokinetic analysis showed that HS-10383 has a terminal half-life of 35-48 hours, supporting once-daily oral administration.¹。

The project is currently conducting a Phase II, randomized, double-blind, placebo-controlled, parallel-design study to evaluate the efficacy, safety, and tolerability of HS-10383 administered orally once daily at different doses (CTR20240165; NCT06246565).

Hansoh PharmaMs. Sun Yuan, Executive Director, stated:

Given the significant unmet need in treating chronic cough, the development of P2X3 receptor antagonists represents an important advancement with the potential to fill this gap. Our candidate drug, HS-10383, has a unique structure that can highly selectively inhibit the P2X3 receptor, which is expected to reduce coughing episodes in patients while significantly minimizing the impact on their taste function. This offers new hope for patients suffering from chronic cough, providing a more effective and well-tolerated treatment option.

About HS-10383

HS-10383 is a highly selective P2X3 receptor antagonist independently developed by Hansoh Pharma for the treatment of RUCC. The P2X3 receptor plays an important role in the cough transmission pathway and is considered a key target for RUCC treatment. Multiple clinical trials have identified P2X3 receptor antagonists as a potential therapy, offering new hope for patients with RUCC.The company believes that its highly selective P2X3 antagonist has unique advantages and is considered an effective approach for treating RUCC. It can effectively reduce the frequency of cough with minimal impact on taste function, thereby offering patients better efficacy and treatment compliance.

About Chronic Cough

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.^2,3However, the current effective treatment options for RUCC are limited, 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.

About Hansoh Pharma

Hansoh Pharma is a leading innovation-driven pharmaceutical company in China, with subsidiaries including Hansoh Pharmaceuticals, Changzhou Hengbang Pharmaceuticals, and Hansoh Biologics. The company focuses on key areas such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases.In the field of treatment for major diseases such as cancer, it is committed to improving the quality of human life through continuous innovation. As of the first half of 2024, the company has launched 7 innovative drugs, and the revenue share of innovative products has reached77.4%. Hansoh Pharma has ranked among the top 100 global pharmaceutical enterprises for many consecutive years and has been among the top three in China's best industrial enterprises for pharmaceutical R&D product lines. It is a key national high-tech enterprise and a national technology innovation demonstration enterprise. The company was listed on the Hong Kong Stock Exchange in June 2019 (Stock Code: 03692.HK). For more information, please visit: https://cn.hspharm.com/.

References:

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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