Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) has announced that the last subject in its RESOLVE-1 third phase lenabasum study for systemic sclerosis treatment has competed for its last visit. The company is on track to release top-line data from the trials in the summer of 2020.
Corbus finalized RESOLVE-1 Phase 3 study in time
The company’s Chief Executive Officer Yuval Cohen indicated that they were delighted to finalize the study in time amid the coronavirus pandemic. Yuval acknowledged the efforts of the company’s staff, collaborators, and study subjects to ensure the study is completed in time.
Corbus’s RESOLVE-1 third phase study is a multinational study that evaluated the safety and efficacy of lenabasum in the treatment of systemic sclerosis. The study was a randomized, double-blind, placebo-controlled trial where subjects were given 20mg of lenabasum twice each day or 5mg of lenabasum twice daily or placebo twice a day around 52 weeks. There was a 28-day safety follow-up, after which study participants can elect to take part in the current open-label extension study of RESOLVE-1.
In the study, the primary endpoint was a composite score called ACR CRISS that was measured after 52 weeks. Similarly, ACR CRISS was the main endpoint in the previous second phase study that the company published recently in Arthritis & Rheumatology. On the other hand, secondary efficacy endpoints included the change from Week 52 baseline in modified Rodnan skins score, forced vital capacity present predicted, and Health Basement Questionnaire Disability index. There were around 365 patients enrolled in the RESOLVE-1 phase 3 study.
Lenabasum has orphan designation for the treatment of systemic sclerosis
The disease baseline characteristics of the participants were the same as those of participants in the second phase. They were recently presented at the European League Against Rheumatism 2020 e-Congress and the 2019 Annual American College of Rheumatology Meeting.
Already the FDA has granted lenabasum Fast track and Orphan Drug designations for systematic sclerosis treatment. Also, the European Medicines Agency has granted lenabasum Orphan Designation for systemic sclerosis treatment.