Hansoh Pharma Announces Positive Phase I Results for HS-10506, a Selective OX2R Antagonist for Insomnia, at ECNP 2024

Sep 24, 2024 13:00 CST Updated 13:00

Hansoh Pharma

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September 21-24, the 37th European College of Neuropsychopharmacology (ECNP) Congress was held in Milan, Italy. Hansoh Pharma's original Class 1 new drug HS-10506[A Novel High-Affinity Selective Orexin 2 Receptor (OX2R) Antagonist]The latest research findings were announced at the conference in the form of a poster, with insomnia as its potential indication.

The ECNP Congress is the largest conference in Europe dedicated to applied and translational neuroscience, attracting approximately 6,000 medical researchers annually from fields such as neuropsychopharmacology, psychiatry, and neurology worldwide. It aims to jointly explore the latest advances in mental health and brain disorders.

The clinical research results published at the ECNP conference showed that HS-10506 was orally administered as a single dose.After(Up to 60mg) demonstrated good safety and tolerability, favorable PK characteristics, and elicited the expected pharmacodynamic (sedation) effects. Overall, the study data support the further clinical development of HS-10506 for the treatment of insomnia.

Research Results

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of HS-10506 in Healthy Subjects

Presentation Format: Poster Discussion

Poster Number: #P4044

First Author: Li Yan (Shanghai Mental Health Center)

Corresponding Author: Hua-Fang Li (Shanghai Mental Health Center, the principal investigator of this study)

Time: September 21-24, 2024

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[Research Introduction]

HS-10506 is a novel, high-affinity, selective OX2R receptor antagonist that has demonstrated sleep-promoting effects on the orexin system in preclinical studies and is currently under development for the indication of insomnia. The purpose of this study is to investigate the safety, tolerability, and pharmacokinetic characteristics of HS-10506 after single oral administration in healthy Chinese subjects.

[Research PartyMethod

This was a randomized, double-blind, placebo-controlled trial. Fifty-two healthy subjects were assigned to five dose groups (2.5mg, 7.5mg, 20mg, 40mg, and 60mg) and received a single dose of HS-10506 or placebo in the morning. Safety assessments included adverse events (AEs), vital signs, electrocardiograms, clinical laboratory tests, and evaluation of suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS). Plasma concentrations of HS-10506 were determined using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method with a lower limit of quantification of 0.2 ng/mL. A power function model was used to evaluate the proportional dose-response relationship of HS-10506.

[Research Results]

No deaths, serious adverse events, or discontinuations due to safety issues occurred in this study. At least one AE was reported in 33 of 39 subjects (84.6%) treated with HS-10506 and in 5 of 13 subjects (38.5%) treated with placebo. The most common AEs (>2 cases) were drowsiness (76.9% in the HS-10506 group vs. 38.5% in the placebo group), somnolence (71.8% vs. 23.1%), and dizziness (10.3% vs. 0%). No clinically significant abnormalities were observed in vital signs (e.g., heart rate, blood pressure), laboratory tests, or C-SSRS suicide scale assessments. The incidence rates of somnolence in the HS-10506 2.5mg, 7.5mg, 20mg, 40mg, and 60mg dose groups were 0% (0/6), 50.0% (3/6), 88.9% (8/9), 88.9% (8/9), and 100.0% (9/9), respectively, compared to 38.5% (5/13) in the placebo group. All other AEs, except for drowsiness and somnolence, were mild in severity. Overall, somnolence-related AEs associated with HS-10506 (7.5~60 mg) were reported shortly after dosing, ranging from mild to severe, with an incidence showing a certain dose-dependent trend as the dose increased. HS-10506 was rapidly absorbed, with a median T._maxThe range is 0.5 to 1.0 hours, with a terminal half-life of approximately 2 to 5 hours. After a single dose of HS-10506, plasma exposure increases with dose escalation, and the increase in exposure is slightly lower than the increase in dose.

[Research Conclusion]

HS-10506 demonstrated good safety and tolerability after single oral doses (up to 60mg), with favorable PK characteristics and the expected pharmacodynamic (sedation) effects. Overall, the study data support further clinical research of HS-10506 for the treatment of insomnia.

About Hansoh

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 major therapeutic areas such as oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases, and is committed to improving the quality of human life through continuous innovation. As of the first half of 2024, the company has launched seven innovative drugs, with revenue from innovative products accounting for 77.4% of total revenue. The company has consistently ranked among the top 100 global pharmaceutical enterprises and the top three best industrial enterprises in China's pharmaceutical R&D product line for many years. 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/.

Source: Hansoh Pharma

During the advancement of this project research, Herun Dongfang, the SMO subsidiary under Borun Sunshine, actively contributed to the Phase Ib/II clinical trial as a partner. Over the years, Borun Sunshine has also maintained a good cooperative relationship with Hansoh Pharma.

Congratulations again to Hansoh Pharma! We look forward to more exciting research results from this project in the future. Borun Sunshine will continue to support more new drug developments.More new and effective drugs are launched to benefit a large number of patients!

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