On September 21-24, the 37th Congress of the European College of Neuropsychopharmacology (ECNP) was held in Milan, Italy. The latest clinical research data on Hansoh Pharma's HS-10506, a novel, high-affinity selective orexin-2 receptor (OX2R) antagonist, were presented in the form of a poster at the conference, with insomnia as its potential indication.
The annual ECNP Congress is Europe’s premier scientific meeting for disease-oriented brain research, annually attracting around 6,000 psychiatrists, neuroscientists，neurologists and psychologists from around the world.
The recently published clinical trial results of HS-10506 was safe and well-tolerated following a single oral dose up to 60 mg with a favorable PK profile and a desired pharmacodynamic (somnolence) effect. Overall, the data support continued clinical development of HS-10506 for insomnia.
Study Profile
A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Study of HS-10506 in Healthy Subjects
Format:Poster Presentation
Abstract:#P4044
First author：Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Yan Li
Last author：Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Huafang Li
DATE: September 21-24, 2024
Introduction and Objective:
HS-10506, a novel, high affinity selective OX2R antagonist which targets the orexin system with sleep-promoting effects in preclinical studies, is under investigation for insomnia treatment. The objective of this study is to investigate the safety, tolerability, and pharmacokinetic characteristics of HS-10506 after single oral administration in Chinese healthy subjects.
Methods:
This was a randomized, double-blind, placebo-controlled trial. Fifty-two healthy subjects in 5 dose-groups (2.5 mg, 7.5 mg, 20 mg, 40 mg, and 60 mg) received HS-10506 or placebo once in the morning. Safety assessments included adverse events (AEs), vital signs, electrocardiograms, clinical laboratory assessments, and suicidality evaluation per Columbia Suicide Severity Rating Scale (C-SSRS). HS-10506 plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry with a lower limit of quantitation of 0.2 ng/mL. The dose proportionality of HS-10506 was assessed by log-transformed AUC and Cmax using a power model.
Results:
No deaths, serious adverse events (AEs) or early withdrawal events due to safety issue were reported in this study. Overall, 33 of 39 subjects (84.6%) who received HS-10506 and 5 of 13 placebo-treated subjects (38.5%) had at least one adverse event. The most common AEs (>2 cases) were sleepiness (76.9% for HS-10506 versus 38.5% for placebo), somnolence (71.8% for HS-10506 versus 23.1% for placebo) and dizziness (10.3% for HS-10506 versus 0 for placebo).).No clinically significant abnormalities were observed in the vital signs (heart rate, blood pressure), clinical laboratory data and C-SSRS evaluation. The incidences of somnolence were reported as 0% (0/6), 50.0% (3/6), 88.9% (8/9), 88.9% (8/9) and 100.0% (9/9) in the 2.5, 7.5, 20, 40 and 60 mg HS-10506 dose groups, respectively, and 38.5% (5/13) in the placebo group. Except for somnolence and drowsiness, all other AEs were mild in severity. In general, somnolence was reported shortly after drug administration (7.5-60 mg), which was of mild to severe intensity, and showed a dose-related trend. HS-10506 was rapidly absorbed with a median Tmax ranging from 0.5 to 1.0 hour and a terminal half-life of ~2-5 hours. Systemic exposure to HS-10506 increased with dose in a less than dose-proportional manner.
Conclusion:
HS-10506 was safe and well-tolerated following a single oral dose up to 60 mg with a favorable PK profile and a desired pharmacodynamic (somnolence) effect. Overall, the data support continued clinical development of HS-10506 for insomnia.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional.
Forward-Looking Statements
This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).
