Moberg Pharma Completes Enrollment for MOB-015 Phase 3 Study in Europe

瑞典制药 Moberg 完成治疗甲癣新药 MOB -015的 III 期临床试验患者招募工作

2019-03-25 19:38:00 BioSpace


Moberg Pharma AB has completed the recruitment of 452 patients with onychomycosis for the ongoing MOB-015 phase 3 study in Europe. Two Phase 3-studies are currently underway in North America and Europe with topline results expected in the fourth quarter of 2019 and the second quarter of 2020 respectively. Phase 3 studies for MOB-015 are progressing in Europe and North America evaluating the efficacy and safety of MOB-015, Moberg Pharma's proprietary topical formulation of terbinafine. The primary endpoint for both trials is the proportion of subjects achieving complete cure of their target nail at 52 weeks. The enrollment to the European study has now been completed with 452 patients randomized at 48 sites in Europe. Topline results from the European Phase 3 study are expected in the second quarter of 2020. The North American study was fully enrolled in September 2019, with topline results expected in the fourth quarter of 2019. "Completing the Phase 3 enrollment for MOB-015 is truly an important milestone. I am very grateful to the team for the hard work in completing the recruitment for both studies. More than 5,000 patients have been screened to recruit 800+ patients in the rigorous screening process, ultimately increasing the probability of strong phase 3 results for MOB-015", says Peter Wolpert, Moberg Pharma's CEO.
Moberg Pharma AB 已完成452例甲癣患者的招募工作,用于正在进行的欧洲 MOB-015期3研究。北美和欧洲目前正在进行两项三期研究,预计分别在2019年第四季度和2020年第二季度取得一线成果。 欧洲和北美正在进行 MOB-015的第3阶段研究,评估莫伯格制药公司特比萘芬的专有外用制剂 MOB-015的疗效和安全性。两个试验的主要终点都是在52周内完成治疗目标指甲的受试者比例。 欧洲研究的注册现已完成452名患者随机在48个地点在欧洲。欧洲第三阶段研究的主题结果预计将在2020年第二季度公布。 北美研究于2019年9月全面纳入,预计将于2019年第四季度发布一线结果。 “完成 MOB-015的第3阶段注册确实是一个重要的里程碑。我非常感谢团队为完成这两项研究的招聘所付出的努力。Moberg Pharma 首席执行官 Peter Wolpert 说,超过5000名患者已经接受了筛选,以招募800多名患者参与严格的筛选过程,最终提高了 MOB-015第3阶段强劲结果的可能性。