Corbus Pharmaceuticals Holdings Inc CRBP shares were plummeting hard Tuesday following an adverse clinical data readout.
What Happened: Top-line results from the 52-week Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis did not meet the primary and secondary endpoints of the study, according to the Norwood, Massachusetts-based micro-cap biopharma.
The company is working on medicines targeting the endocannabinoid system.
"Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both added to background drug therapy," the company said Tuesday.
The RESOLVE-1 study tested the efficacy and safety of lenabasum in 365 patients with diffuse cutaneous SSc in a multinational study, with dosing of lenabasum at 20mg twice daily; lenabasum at 5mg twice daily; or placebo twice daily for 52 weeks.
About 84% of the enrolled patients were receiving background immunosuppressive drugs, in line with the recent trends in clinical practice, Corbus said.
The primary endpoint was the median American College of Rheumatology Combined Response Index for Systemic Sclerosis scores, a composite endpoint that reflects the probability of patient improvement.
At week 52, the drug's score was 0.887 in the placebo arm and 0.888 in the lenabasum 20mg twice daily arm, the company said.
The investigational asset was found safe and well-tolerated in the study, with no new safety signals observed, according to Corbus.
Why It's Important: Lenabasum, Corbus' lead asset and its only pipeline asset in clinical development, is an oral small molecule that selectively binds as an agonist to the cannabinoid receptor type 2, resolving inflammation and limiting fibrosis.
SSc is a rare and life-threatening multi-system autoimmune disease for which there are currently no FDA-approved treatments for overall disease. It affects 200,000 people in the North America, European Union and Japan.
The disease affects the skin and internal organs, manifesting as inflammation and fibrosis, which can lead to severe damage and failure of multiple organs.
What's Next? Corbus said further analysis of data is underway, and results will be presented at upcoming medical conferences.
Lenabasum is being evaluated in a Phase 3 study in dermatomyositis, a Phase 2 study in systemic lupus erythematosus and a Phase 2b study in cystic fibrosis.
At last check, Corbus shares were slumping 75.78% to $2.24.
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