Rare Disease Report

Endocannabinoid Shows Promise in Systemic Sclerosis Study

NOVEMBER 15, 2016
Andrew Black
Corbus Pharmaceuticals has announced new data from its phase 2 diffuse cutaneous systemic sclerosis study testing its’orphan drug Resunab (JBT-101) and the results are impressive.
 
In the Phase 2 double-blind, randomized, placebo controlled trial, JBT-101 showed statistically significant results compared to placebo the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous systemic sclerosis (CRISS) score. 
 
The 42 patients involved in the study were 18 Years to 70 years old. Subjects had disease duration up to 6 years and were allowed to receive stable doses of immunosuppressive drugs during this study. 
 
Dosing included the first four weeks at 5 mg once a day (n = 9), 20 mg once a day (n = 9), or 20 mg twice a day (n = 9)The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.

Results

At week 16 of the study, JBT-101 reached 33% where placebo remained at 0% (P = 0.044). A CRISS score ≥20% (CRISS20) is considered a medically meaningful improvement.
 
Group Week 4 Week 8 Week 12 Week 16
JBT-101
n = 26
3%
(0.6%, 11.4%)
19%
(0.3%, 69.2%)
27.5%
(1.9%, 67.8%)
33%
(.08%, 82.1%)
Placebo
n = 15
1%
(.03%, 8.8%)
1%
(0.1%, 15.2%)
1%
(0.1%, 60.1%)
0%
(0.1%, 16%)

Stock Watch

Shares of Corbus are currently at $8.48. And is down 3.95% after doubling yesterday.

About Resunab

Resunab or JBT-101 is an oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis.
 
It is currently being evaluated in four Phase 2 clinical trials for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis ("scleroderma"), dermatomyositis and systemic lupus erythematosus.
 
About Systemic Sclerosis
Systemic sclerosis is a multisystem autoimmune disease in which there is increased fibroblast activity resulting in abnormal growth of connective tissue. This causes vascular damage and fibrosis. Fibrosis occurs in skin, the gastrointestinal (GI) tract, heart, lungs and other internal organs. Vascular manifestations include secondary Raynaud's phenomenon, ischaemia of extremities, pulmonary arterial hypertension and renal disease.
 


 



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