Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) has reported that its systemic sclerosis study failed to reach the endpoints, and investors were not pleased. Shares were absolutely crushed early Tuesday.
The clinical-stage pharmaceutical company announced topline results from the 52-week Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc). The data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo.
Note that SSc is a rare and life-threatening multisystem autoimmune disease for which there are currently no U.S. Food and Drug Administration (FDA)-approved treatments for overall disease.
Despite this setback, management was quick to note that further analyses of these data are underway, and once Corbus has a fuller understanding of the data, the company plans to engage with the FDA to determine potential next steps in this clinical development program.
Previously, 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.
Lenabasum 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.
Corbus Pharmaceuticals stock traded down more than 75% early Tuesday, at $2.25 in a 52-week range of $3.29 to $9.78. The consensus price target was $25.14 on last look.