Traws 新冠口服药 ratutrelvir 二期最终结果：症状消退13.5天对14.5天，28天内无病毒反弹
美国宾夕法尼亚州 Newtown 的临床阶段生物制药公司 Traws Pharma（Nasdaq: TRAW）11月12日公布其在研新冠口服药 ratutrelvir 的 2a 期试验最终结果：这款每日一次、无需利托那韦增效的口服抗病毒药，在可用辉瑞 PAXLOVID 的患者中，持续症状消退的中位时间为 13.5 天，对照 PAXLOVID 组的 14.5 天，第 28 天时未见病毒反弹。
这项随机、活性对照试验共纳入 92 名轻至中度新冠患者。其中 62 名可用 PAXLOVID 的患者分别接受 ratutrelvir 600 毫克每日一次、连服 10 天，或 PAXLOVID 连服 5 天；两组鼻腔病毒 RNA 下降速度相近，ratutrelvir 组 32 人中有 1 人报告治疗相关不良事件，PAXLOVID 组 30 人中有 4 人。另设的 30 人队列为因合并用药禁忌等原因不能使用 PAXLOVID 的患者，这组患者年龄较大、心肺合并症负担较重，服用 ratutrelvir 后症状消退时间为 14.0 天，未报告治疗相关不良事件。
Traws 首席医疗官 Robert R. Redfield 表示，最终结果支持 ratutrelvir 作为每日一次、无需利托那韦方案的潜力，包括服务于因其他药物而不能使用利托那韦增效疗法的患者，其耐受性与无病毒反弹的表现值得进一步临床评估。公司表示，ratutrelvir 对已测试的 12 株新冠病毒毒株均有体外活性，其作用靶点为主蛋白酶 Mpro，该酶在各变异株间高度保守。
公司下一步拟与美国食品药品监管局（FDA）商议注册路径，重点放在有进展为重症风险、又不能使用 PAXLOVID 的成年患者，讨论内容包括适应性 2b 期或关键性试验方案与快速通道认定。ratutrelvir 尚未获任何监管机构批准。
同日公布的还有其长效流感预防药 tivoxavir marboxil（TXM）压片剂型的桥接研究完成结果：片剂暴露量与胶囊粉剂相当、耐受良好，支持每月一次给药的潜力。TXM 毒理复测中，两项独立的大鼠 Pig-a 基因突变研究在最高 500 毫克每公斤剂量下未见致突变效应，约为计划临床暴露的 125 倍，公司预计 2026 年第四季度向监管机构重新提交更新材料。（来源：Traws Pharma）
Traws Pharma Reports Final Phase 2a Results for Ratutrelvir: Symptom Resolution in 13.5 Days vs 14.5, No Viral Rebound Through Day 28
Traws Pharma, Inc. (Nasdaq: TRAW), a clinical-stage biopharmaceutical company based in Newtown, Pennsylvania, on November 12 announced the final results of its Phase 2a study of ratutrelvir, an investigational once-daily, ritonavir-free oral antiviral for COVID-19. In patients eligible to receive Pfizer's PAXLOVID, the median time to sustained symptom resolution was 13.5 days with ratutrelvir versus 14.5 days with PAXLOVID, with no viral rebound observed through Day 28.
The randomized, active-controlled study enrolled 92 subjects with mild-to-moderate COVID-19. Among 62 PAXLOVID-eligible subjects, ratutrelvir 600 mg once daily for 10 days was compared with PAXLOVID for 5 days; viral RNA declined at a similar rate in both arms, and treatment-related adverse events were reported in 1 of 32 ratutrelvir patients and 4 of 30 PAXLOVID patients. A separate cohort of 30 PAXLOVID-ineligible subjects, who were older and carried a high burden of cardiovascular and pulmonary comorbidities, saw symptoms resolve in 14.0 days on ratutrelvir, with no treatment-related adverse events reported.
Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma, said the final results support the potential of ratutrelvir as a once-daily, ritonavir-free treatment option, including for patients who cannot take ritonavir-boosted therapy because of their other medications, and that its tolerability profile and the absence of viral rebound encourage further clinical evaluation. The company said ratutrelvir has shown in vitro activity against all 12 SARS-CoV-2 strains tested to date and acts on the viral main protease Mpro, an enzyme highly conserved across variants.
Traws intends to discuss a registration strategy with the U.S. Food and Drug Administration (FDA) focused on adults at high risk of progression to severe COVID-19 who are ineligible for PAXLOVID, including a potential adaptive Phase 2b or pivotal program and Fast Track designation. Ratutrelvir has not been approved by any regulatory authority.
The company also announced completion of a bridging study of a compressed tablet formulation of tivoxavir marboxil (TXM), its investigational once-monthly antiviral for seasonal and pandemic influenza prophylaxis. The tablet provided comparable exposure to the powder-in-capsule form and was well tolerated. In a toxicology retest, two independent rat Pig-a gene mutation studies showed no mutagenic effect at doses up to 500 mg/kg, a margin of about 125-fold over the planned clinical exposure, and the company expects to resubmit the updated package to regulators in the fourth quarter of 2026. (Source: Traws Pharma)
来源：Traws Pharma
发布：GSM·美国（发布链接）
图片来源：图：新冠病毒 SARS-CoV-2 示意图。CDC 的 Alissa Eckert 与 Dan Higgins 制，Wikimedia Commons，公共领域。 / Image: Illustration of the SARS-CoV-2 virus. By Alissa Eckert and Dan Higgins, CDC, via Wikimedia Commons, public domain.
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