Geneva, Switzerland, May 2, 2024 – STALICLA SA, a late-stage biotechnology company specializing in precision medicine for brain disorders, announces the First Patient First Visit (FPFV) for the company's drug-drug interaction (DDI) study of STP7 (Mavoglurant), an mGluR5 negative allosteric modulator, licensed to STALICLA by Novartis.  The DDI study is the last regulatory requirement in a comprehensive Phase 2 program and completion is expected to trigger initiation of a Phase 3 study in the U.S.

瑞士日内瓦，2024年5月2日–STALICLA SA，一家专门从事脑部疾病精准医学的晚期生物技术公司，宣布首次患者首次就诊（FPFV），用于该公司对STP7（Mavoglurant）的药物-药物相互作用（DDI）研究，STP7是一种mGluR5阴性变构调节剂，由诺华公司授权给STALICLA。DDI研究是全面的第二阶段计划中的最后一项监管要求，预计完成后将在美国启动第三阶段研究。

in 2025. Lynn Durham, CEO and Founder of STALICLA said, “This DDI study unlocks the opportunity under our Cooperative Research and Development Agreement with the U.S. NIH National Institute of Drug Abuse (NIDA) to begin Phase 3 trials for STP7 in 2025 to address the high unmet medical need of cocaine abuse globally.

2025年。STALICLA首席执行官兼创始人林恩·达勒姆（LynnDurham）表示：“根据我们与美国国立卫生研究院国家药物滥用研究所（NIDA）的合作研发协议，这项DDI研究为2025年开始STP7的第三阶段试验提供了机会，以解决全球可卡因滥用的高度未满足的医疗需求。

Results from successfully completed Phase 2 studies for cocaine use disorder (CUD) showed highly convincing and unprecedented efficacy results including increase in abstinence from cocaine use and reduction in co-morbid dependencies such as alcohol abuse with STP7 (Mavoglurant).In addition, STALICLA is investigating alternative therapeutic indications for STP7 (Mavoglurant) to benefit patients with other CNS conditions.” STP7 (Mavoglurant) is the most clinically advanced negative allosteric modulator of the glutamate receptor 5 (mGluR5 NAM).

成功完成的可卡因使用障碍（CUD）第二阶段研究的结果显示出高度令人信服且前所未有的疗效结果，包括可卡因使用戒断率的增加以及与STP7（Mavoglurant）酗酒等共病依赖性的减少。此外，STALICLA正在研究STP7（Mavoglurant）的替代治疗适应症，以使患有其他中枢神经系统疾病的患者受益。”STP7（Mavoglurant）是谷氨酸受体5（mGluR5-NAM）的临床上最先进的负变构调节剂。

As well as its role in addiction pathophysiology, mGluR5 has been implicated in mood disorders and neurodevelopmental disorders such as Fragile X and autism spectrum disorder. Comprehensive clinical studies by Novartis of STP7 (Mavoglurant) to date have included over 1800 adults for up to 2 years, demonstrating good safety and tolerability and significant reduction in cocaine use and positioning STP7 (Mavoglurant) as a strong can.

mGluR5除了在成瘾病理生理学中的作用外，还与情绪障碍和神经发育障碍有关，例如脆性X和自闭症谱系障碍。迄今为止，诺华公司对STP7（Mavoglurant）进行的全面临床研究已包括1800多名成年人长达2年，证明其具有良好的安全性和耐受性，并显着减少了可卡因的使用，并将STP7（Mavoglurant）定位为一个强大的can。

Attachment

附件

STALICLA PR DDI 02052024_final

STALICLA PR DDI 02052024\U最终版本