
安进和阿斯利康周二表示,其哮喘药物有助于减轻吞咽困难,并使一种慢性炎症性食管疾病患者中69%的患者实现疾病缓解。
Amgen and AstraZeneca said on Tuesday their asthma drug helped reduce swallowing difficulties and achieved disease remission in 69% of patients with a type of chronic inflammatory disorder of the esophagus.
该结果基于8月份的数据,当时阿斯利康表示,该药物在24周治疗后达到了试验的主要目标,与安慰剂相比,减轻了食管炎症并缓解了吞咽困难。
The result builds on August data, when AstraZeneca said the drug met the trial's main goals after 24 weeks of treatment by reducing esophageal inflammation and easing swallowing difficulties versus placebo.
该药物Tezspire正在研究用于患有症状性和未控制的嗜酸性食管炎的患者,这种疾病会导致食管肿胀和刺激,使吞咽困难,有时还会导致食物卡住。这种单克隆抗体阻断一种名为TSLP的蛋白质,该蛋白质驱动哮喘和嗜酸性食管炎中涉及的炎症通路。约65%接受210毫克剂量和69%接受420毫克剂量的患者在24周时实现了炎症缓解,而安慰剂组患者为3.5%。
公司表示,益处持续至52周,接受210毫克剂量的患者中有67.8%和接受420毫克剂量的患者中有63.3%实现了疾病缓解,而安慰剂组为5.4%。Tezspire在24周后将吞咽困难评分降低了210毫克剂量下的18.8分和420毫克剂量下的22分,而安慰剂组降低了14.7分。最常报告的副作用是上呼吸道感染、头痛和腹泻。该药物已在多个国家获批,作为重度哮喘的附加治疗,并与赛诺菲(SASY.PA)和再生元(REGN.O)的畅销药Dupixent竞争。
The drug Tezspire is being studied in patients with symptomatic and uncontrolled eosinophilic esophagitis, which causes swelling and irritation in the food pipe, making swallowing difficult and sometimes causing food to get stuck The monoclonal antibody blocks a protein called TSLP that drives the inflammatory pathway involved in both asthma and eosinophilic esophagitis About 65% on the 210 mg dose and 69% of patients on the 420 mg dose of the drug achieved remission of inflammation at 24 weeks, compared with 3.5% of patients on placebo The companies said the benefits were maintained through 52 weeks, with 67.8% of patients on the 210 mg dose and 63.3% on the 420 mg dose achieving disease remission, compared with 5.4% on placebo Tezspire reduced swallowing-difficulty scores by 18.8 points at the 210 mg dose and 22 points at the 420 mg dose after 24 weeks, compared with a 14.7-point reduction with placebo The most commonly reported side effects were upper respiratory infections, headache and diarrhea The drug is already approved in a number of countries as an add-on treatment for severe asthma and competes with Sanofi (SASY.PA) and Regeneron's (REGN.O) blockbuster drug Dupixent