Dive Brief:
- In topline results of a Phase 2 trial of Corbus Pharmaceuticals' cannabinoid mimetic, resunab, patients with diffuse cutaneous systemic sclerosis saw clear signs of clinical benefit. Patients taking resunab had CRISS response scores, which measure improvement, of 33% at week 16, compared with 0% in placebo-treated patients (p=0.044).
- There are currently more than 90 cannabinoid-based products in drug development across the biopharma pipeline, with about 82% of them in preclinical or discovery stages, according to a report from consulting firm GBI Research.
- Corbus stock surged up yesterday, ending the day up by more than 50% on the news about its drug, which has orphan drug designation and fast track status. The company's stock value has risen by over 400% in the year-to-date.
Dive Insight:
Diffuse cutaneous systemic sclerosis is a chronic fibrotic rheumatic disease that affects around 90,000 people in the U.S. and Europe. Its cause isn't clear, and it affects organs throughout the body. It has no specific treatment other than for its signs and symptoms, and few companies are developing drugs in this field.
Resunab (JBT-101), which is Corbus' only clinical stage drug, is a synthetic, oral endocannabinoid. It works by 'turning off' chronic inflammation and slowing or stopping fibrosis without suppressing the immune system.
"The positive results of this study exceed our expectations and validate the unique mechanism of action of JBT-101. Our drug previously demonstrated clear and consistent evidence of activity in cellular and animal models as well as in healthy volunteers, repeatedly showing that its engagement with the CB2 receptor and its activation of inflammatory resolution translates into a potent effect on inflammation and fibrosis," said Yuval Cohen, CEO of Corbus. "We look forward to the next stages in the clinical development of this drug."
As well as diffuse cutaneous systemic sclerosis, resunab is currently in Phase 2 clinical studies for the treatment of cystic fibrosis and skin-predominant dermatomyositis, with a fourth Phase 2 trial in systemic lupus erythematosus planned for the first half of 2017. Submission for approval in scleroderma could take place in 2021.