Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) shares skyrocketed on Monday morning after the company announced positive results from its mid-stage clinical trial in systemic sclerosis. Essentially, the company reported positive top-line results from its Phase 2 study evaluating Resunab (JBT-101) for the treatment of diffuse cutaneous systemic sclerosis.
JBT-101 outperformed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous systemic sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo.
There were no serious, severe, or unexpected adverse events related to JBT-101. One of 27 subjects (3.7% of subjects) who received JBT-101 withdrew from the study for an adverse event, which was moderate dizziness.
The primary treatment period has been completed and the patients are now enrolled in a one-year open label extension to obtain data on long-term safety and durability of response. Corbus received approval for an open-label extension to its Phase 2 clinical study of JBT-101 for systemic sclerosis from the U.S. Food and Drug Administration (FDA) back in April. The open-label extension enables all the participants in the study to receive JBT-101 for an additional 12 months.
JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis by the FDA in 2015.
Principal Investigator Robert Spiera, M.D., Director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City, commented:
This is the first double-blind, randomized, placebo controlled trial in diffuse cutaneous systemic sclerosis to demonstrate a clinical benefit using the CRISS as an endpoint, with a drug that was safe and well tolerated in the trial. These results bring hope to patients and their physicians that JBT-101 may be an effective drug for systemic sclerosis where currently there are no proven treatments.
Yuval Cohen, Ph.D., CEO of Corbus, added:
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. With the data from this Phase 2 study, we now show that this mechanism of action provided clinical benefit in patients with systemic sclerosis in this trial. We look forward to the next stages in the clinical development of this drug. We are sincerely grateful to the patients, their physicians and the clinical staff who participated in this trial.
Shares of Corbus were last seen up 66% at $9.72, with a consensus analyst price target of $14.25 and a 52-week trading range of $1.01 to $10.78.