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June 13, 2018 09:29ET|Source:Corbus Pharmaceuticals Holdings, Inc.

Multiple key efficacy outcomes further improved in open-label extensions of systemic sclerosis (SSc) and dermatomyositis (DM) Phase 2 studies

Lenabasum continues to demonstrate a favorable safety profile with chronic dosing

SSc and DM are related, rare and serious systemic autoimmune diseases with limited treatment options

120,000 individuals with diffuse cutaneous SSc and DM in US, EU and Japan

Norwood, MA, June 13, 2018 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases, announced today that data from open-label extensions (OLEs) of its systemic sclerosis (SSc) and dermatomyositis (DM) Phase 2 studies are being presented at the Annual European Congress of Rheumatology (EULAR 2018).

Key highlights from the data being presented include:

SSc OLE 1-Year Results

mRSS improved by a mean of -9.4 from baseline at the start of the Phase 2 double-blind, placebo-controlled phase of the study;

ACR CRISS increased steadily with lenabasum treatment and reached 92% (median), with 50% of subjects achieving a score>95% at 1 year; and

77% of subjects achieved a degree of improvement in mRSS that is considered medically meaningful (reduction 5 points), and 50% achieved 10 points improvement in mRSS.

DM OLE 6-Month Results

CDASI activity score improved by a mean of -15.4 points from baseline at the start of the Phase 2 double-blind, placebo-controlled phase of the study; and

88% of subjects achieved reduction 5 points, which is considered medically meaningful, 82% achieved reduction 10 points, and 47% had reached a low CDASI activity score ( 14 points).

We now have long-term safety and efficacy data in two related, rare and serious autoimmune diseases, SSc and DM,Barbara White, M.D., Chief Medical Officer of the Companystated. I believe that the favorable safety profile and the consistency and magnitude of changes in efficacy outcomes affirm a durability of treatment effect for lenabasum and show a cross-substantiation of data between the two studies. The degree of improvement in mRSS and CRISS scores in the SSc study, and in CDASI activity scores in the DM study are considerable, increased over time, and strengthen our confidence that lenabasum could offer benefit to patients with these diseases.

Systemic Sclerosis Oral Presentation Overview

The abstract entitled, Safety and Efficacy of Lenabasum (JBT-101) In Diffuse Cutaneous Systemic Sclerosis Subjects Treated for One Year in An Open-Label Extension of Trial JBT101-SSc-001,(Abstract #3512) was presented in an oral presentation by 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 and Principal Investigator of the Phase 2 and Phase 3 trials in SSc. To access the presentation, clickhere.

Study Design

Thirty-six subjects with diffuse cutaneous SSc received open-label dosing with lenabasum at 20 mg twice per day following 16-weeks participation in the preceding double-blinded placebo-controlled phase of the lenabasum Phase 2 study. There was an average 20-week wash-out from investigational product prior to the start of the OLE. Twenty-seven subjects completed 1-year follow-up in the OLE at the time of this data-cut. Lenabasum treatment was in addition to standard-of-care treatments for SSc, including stable doses of concomitant immunosuppressive drugs in 94% of subjects.

Efficacy Outcomes

The modified Rodnan Skin Score (mRSS), a physician assessment of skin involvement and the primary outcome for the upcoming Phase 3 study of lenabasum in SSc, improved by a mean of -9.4 points from baseline at the start of the Phase 2 study. The baseline mRSS at study start was 24 points. At 1 year, 77% of subjects achieved a degree of improvement in mRSS that is considered medically meaningful (reduction 5 points), and 50% achieved 10 points improvement in mRSS.

The ACR Composite Response Index in diffuse cutaneous Systemic Sclerosis score (ACR CRISS) increased steadily with lenabasum treatment and reached 92% (median), with 50% of subjects achieving a score>95% at 1 year. ACR CRISS is a measure of improvement in systemic sclerosis which is based on an exponentially weighted algorithm of change from baseline that includes the mRSS as well as physician and patient assessments and forced vital capacity (FVC). Patient-reported disability, function, skin symptoms and global health all improved from study start and OLE start.

The mRSS and ACR CRISS, responses exceeded those seen in the 16-week double-blind placebo-controlled phase and the 6-month time point in the OLE.

Safety