Corbus Pharmaceuticals Holdings Inc. (CRBP), a clinical-stage drug development company, announced Tuesday that its 52-week Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis or SSc did not meet its primary endpoint.
In pre-market activity on Nasdaq, Corbus Pharma shares were losing around 75 percent to trade at $2.35.
SSc is a rare and life-threatening multi-system autoimmune disease. There are currently no treatments approved by the U.S. Food and Drug Administration for overall disease.
The company noted that the topline data from the study showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy.
RESOLVE-1 is the first 52-week, randomized, placebo-controlled Phase 3 trial that tested the efficacy and safety of lenabasum in 365 patients with diffuse cutaneous Ssc.
Corbus noted that further analyses of these data are underway, and once it has a fuller understanding of the data, the company would engage with the FDA to determine potential next steps in this clinical development program.
The data will be presented at upcoming medical conferences.
Lenabasum was granted Orphan Drug designation and Fast Track designation for the treatment of SSc from the FDA and Orphan Designation for the treatment of SSc from the European Medicines Agency.
It is currently being evaluated in a Phase 3 DETERMINE study in dermatomyositis, a Phase 2 study in systemic lupus erythematosus, and a Phase 2b study in cystic fibrosis.
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