Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) a clinical stage drug advancement firm targeting chronic, serious fibrotic and inflammatory diseases, reported positive topline data from its Phase 2 trial assessing Resunab for the cure of systemic sclerosis. JBT-101 exceled placebo in the ACR Combined Response Index in CRISS score, touching 33% at week 16, compared 0% for placebo.
The better the CRISS score the more the improvement. A CRISS score ≥ 20% can be stated a medically significant enhancement. The variance in CRISS scores between placebo groups and JBT-101 over the trial duration was considerable (p = 0.044). Differences in segmental levels of CRISS changes and responses from baseline in the 5 individual units of the CRISS score advanced clinical advantage of JBT-101.
The experts speak
Robert Spiera, M.D., the Principal Investigator in this study, stated that it is the first randomized, double-blind, placebo controlled study in diffuse CRISS to demonstrate a clinical advantage utilizing the CRISS as an endpoint, with a medication that was well-tolerated and safe in the study. This data bring hope to patients and also to their physicians that Resunab may be an effective medication for systemic sclerosis where presently there are no verified treatments.
Yuval Cohen, Ph.D., the Chief Executive Officer of Corbus Pharmaceuticals, said that the positive data of this trial surpass expectations and prove the unique process of action of Resunab. The medication drug previously showed consistent and clear evidence of activity in animal and cellular models, and also in healthy volunteers. It repeatedly showed that its arrangement with the CB2 receptor and its instigation of inflammatory resolution decodes into a powerful effect on fibrosis and inflammation.
With the information from this Phase 2 trial, the company now reveal that this action mechanism offered clinical advantages in subjects with systemic sclerosis in this study. The company look forward to the next phases in the advancement of this medication. Corbus CEO added that they are extremely grateful to the subjects, the clinical staff and their physicians, who participated in this study.