Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new 48-week data for the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib from the Phase II FENopta open-label extension (OLE) study at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark on 18 September 2024.

罗氏（SIX:RO，ROG；OTCQX:RHHBY）将于9月18日在丹麦哥本哈根举行的欧洲多发性硬化症治疗和研究委员会（ECTRIMS）第40届大会上，从II期非诺普塔开放标签延伸（OLE）研究中为研究性布鲁顿酪氨酸激酶（BTK）抑制剂非尼提供新的48周数据2024年。

Results demonstrate that patients with relapsing multiple sclerosis (RMS) treated with fenebrutinib for up to one year maintained very low levels of disease activity and no disability progression. “After a year of treatment, our BTK inhibitor fenebrutinib was able to suppress nearly all disease activity and disability progression in people with multiple sclerosis,’’ said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

结果表明，复发性多发性硬化症（RMS）患者接受非尼鲁替尼治疗长达一年，疾病活动水平非常低，无残疾进展。“经过一年的治疗，我们的BTK抑制剂fenebrutinib能够抑制多发性硬化症患者的几乎所有疾病活动和残疾进展，”罗氏首席医疗官兼全球产品开发负责人Levi Garraway医学博士说。

“If these results are validated in the ongoing Phase III trials, fenebrutinib could further advance the treatment landscape for people living with multiple sclerosis.’’ During the OLE period, 96% of patients treated with fenebrutinib were free of relapses at one year, with an annualised relapse rate (ARR) of 0.04, and no change in disability over 48 weeks as measured by the Expanded Disability Status Scale (EDSS).

“如果这些结果在正在进行的III期临床试验中得到验证，非尼鲁替尼可以进一步改善多发性硬化症患者的治疗前景。”在OLE期间，96%接受非尼鲁替尼治疗的患者在一年内没有复发，年复发率（ARR）为0.04，并且通过扩展残疾状态量表（EDSS）测量，48周内残疾没有变化。

Fenebrutinib treatment suppressed disease activity in the brain as measured by MRI scans. At 48 weeks, 99% of patients were free of T1 gadolinium-enhancing (T1-Gd+) lesions, markers of active inflammation. Over the 48 weeks .

通过MRI扫描测量，Fenebrutinib治疗抑制了大脑中的疾病活动。在48周时，99%的患者没有T1钆增强（T1 Gd+）病变，这是活动性炎症的标志物。在48周内。