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Livzon and Neosun jointly announced: The Phase I clinical trial of KCNQ2/3 activator (NS-041) has been successfully completed.
Release time:
2024-11-15
On November 14, 2024, the wholly-owned subsidiary of Livzon Pharmaceutical Group Inc., Livzon Group Livzon Pharmaceutical Factory (hereinafter referred to as "Livzon Pharmaceutical"), jointly announced with Neuraxpharm (Shanghai) Co., Ltd. (hereinafter referred to as "Neuraxpharm") that the Phase I clinical trial of the small molecule candidate drug NS-041 (a KCNQ2/3 activator) for the treatment of neurological and psychiatric diseases such as epilepsy and depression has recently been successfully completed. This is an important milestone in the clinical development process of the NS-041 project, marking that the project will enter Phase II clinical trials to explore the safety and efficacy of NS-041 in patients with focal epilepsy and other conditions.
The Phase I clinical trial of NS-041 is a randomized, double-blind, placebo-controlled study, designed to evaluate its safety, tolerability, and pharmacokinetic characteristics in healthy adults through single ascending dose (SAD) and multiple ascending dose (MAD) administration. The study explored single doses at five levels and multiple doses at three levels, with results demonstrating good safety and pharmacokinetic characteristics. The project team is currently conducting statistical analysis and report writing, and actively preparing for the Phase II clinical trial.
Mr. Tang Yanggang, Executive Director and President of Livzon Pharmaceutical, stated: "We sincerely thank the teams from both companies for their persistence and efforts. We have high hopes for NS-041 and will continue to work hand in hand with Neuraxpharm to advance the subsequent clinical development, aiming to bring better treatment options to patients as soon as possible."
Dr. Shen Huaqiong, Founder and CEO of Neuraxpharm, stated: "The successful completion of the Phase I clinical trial is attributed to the close cooperation of the teams from both companies, as well as the efficient collaboration of the CRO and clinical centers. The data from this trial lays a solid foundation for the Phase II trial, and we will explore multiple indications next."
NS-041 is a highly selective KCNQ2/3 activator, aimed at treating neurological and psychiatric diseases such as epilepsy and depression. NS-041 has demonstrated good and differentiated efficacy and safety data in preclinical studies, with the potential to become the best in its class. Livzon Pharmaceutical reached an exclusive licensing agreement for the Greater China region with Neuraxpharm for this project in July of this year. The two parties are closely cooperating in the clinical development of NS-041 to accelerate the market entry process of this candidate drug.
The potassium ion channel KCNQ2/3 is considered one of the important targets for the development of next-generation antiepileptic drugs, with its novel mechanism of action expected to provide patients with new and better treatment options. In addition, the potential indications for this target can be expanded to various mood disorders and pain, aiming to address the unmet clinical needs of existing drugs that have slow onset and insufficient efficacy. Currently, candidate drugs targeting the same site are in clinical research stages and have already obtained positive data in epilepsy and major depressive disorder.
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