New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS) More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at 8 weeks The safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,500 people to date Basel, 13 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS) with a consistent safety profile to other fenebrutinib trials.

来自复发性多发性硬化症（RMS）的II期FENopta研究的新数据显示，fenebrutinib穿过血脑屏障，有可能直接作用于与多发性硬化症（MS）相关的慢性炎症。新的/扩大的T2相对减少90%以上病变和新的T1钆增强（Gd+）病变与fenebrutinib从8周开始的安全性概况fenebrutinib与迄今为止在巴塞尔2500多人中进行的先前和正在进行的临床试验一致，即2023年10月13日-罗氏（SIX:RO，ROG；OTCQX:RHHBY）今天宣布了II期FENopta研究的新数据，表明该研究，口服fenebrutinib是脑渗透剂，可减少复发性多发性硬化症（RMS）患者的脑损伤，对其他fenebrutinib试验具有一致的安全性。

The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis). “These interesting results raise the possibility that fenebrutinib slows MS disease progression in part by acting directly within the brain,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

最新数据在第9届联合ECTRIMS-ACTRIMS会议（欧洲和美洲多发性硬化症治疗和研究委员会）的口头报告中得到了特色。罗氏公司首席医疗官兼全球产品开发负责人Levi Garraway博士说：“这些有趣的结果提高了fenebrutinib减缓MS疾病进展的可能性，部分原因是直接在大脑内起作用。”。

“These data, which we are currently confirming in pivotal trials of both relapsing and progressive MS, suggest that fenebrutinib may have the potential to counteract acute and chronic inflammation within the brain to reduce disease activity in people with MS.” Brain penetrance was measured by the level of fenebrutinib in the cerebrospinal fluid (CSF) of a subgroup of 11 patients with RMS.

“这些数据，我们目前正在复发和进行性MS的关键试验中得到证实，表明fenebrutinib可能有潜力抵消大脑内的急性和慢性炎症，从而减少MS患者的疾病活动。”通过11名RMS患者亚组的脑脊液（CSF）中的非尼鲁替尼水平来测量脑外显率。

After 12 weeks of continuous treatment, the mean fenebrutinib concentration was 43.1 ng/mL. Similar fenebrutinib concentrations can produce near-maximal i.

连续治疗12周后，平均fenebrutinib浓度为43.1 ng/mL。类似的fenebrutinib浓度可以产生接近最大的i。

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