Phase 2 Open-Label Extension

Ongoing Phase 2 Open-Label Diffuse Cutaneous Systemic Sclerosis (Scleroderma) Study

Corbus received approval for an open-label extension to its double-blind, placebo-controlled, randomized Phase 2 clinical study of lenabasum for systemic sclerosis from the U.S. Food and Drug Administration (FDA) in April 2016. The open-label extension enables all the participants who completed the double-blind portion of the study the option of enrolling in an open-label extension to receive lenabasum twice a day for an additional 12 months. The goal of the open-label extension study is to collect long term safety and efficacy data on lenabasum.

6-Month Safety and Efficacy Data from Ongoing Open-Label Extension

Lenabasum demonstrated a significant and clinically meaningful reduction in mRSS reaching minus 8.4 (p < 0.0001 2-paired t-test) and an ACR CRISS of 71% at 28 weeks OLE. These responses exceeded those seen in the 12-week double-blind placebo-controlled dosing and increased at each visit with 33% of subjects achieving low mRSS scores (≤ 10 points) and 44% achieving a high ACR CRISS > 70%.

Safety

There were no severe or serious adverse events (AEs) and no clinically significant laboratory abnormalities related to the drug. Thirty (83%) subjects experienced adverse events (AEs) and only 3 (8%) subjects experienced AEs related to lenabasum during open-label dosing. The AEs experienced by ≥ 10% of subjects were upper respiratory tract illness in 7 (19%) subjects and urinary tract infection in 5 (14%) subjects.

Efficacy Outcomes

The modified Rodnan Skin Score (mRSS), the primary outcome for our Phase 3 RESOVLE-1 study of lenabasum in SSc, improved by a mean of -8.4 points (p < 0.0001) from baseline at the start of the Phase 2 double blind placebo controlled portion of the study. The baseline mRSS at study start was 24 points. 75% of subjects achieved a degree of improvement in mRSS (reduction ≥ 5 points and > 25% baseline) that has been associated with improved survival in SSc. A third of subjects reached a low mRSS ≤ 10 points.

The ACR Composite Response Index in diffuse cutaneous Systemic Sclerosis score (ACR CRISS) increased steadily with lenabasum treatment and reached 71% (median) from study start with 44% of subjects achieving a score > 70%. The magnitude of this change is more than double what has been observed in analyses of data from clinical studies with other therapeutics. Patient-reported disability, function, skin symptoms and global health all improved from study start and OLE start. Forced vital capacity (FVC) % predicted was stable during lenabasum treatment (mean change 0.3% predicted from study start) in contrast to the natural history of a decline in FVC in the disease.

For more information, contact:

SSc patients contact: SScpatients@corbuspharma.com
Physicians contact: SScphysicians@corbusphara.com
Other inquiries: info@corbuspharma.com

Site Contact Principal Investigator

Arthritis Association of Southern California

800 W 6th St #1250
Los Angeles, CA 90017
United States

Ethan Zaccagnino

609-895-0735 ext 133
pa.clinicalresearch@gmail.com

Daniel Furst, MD

Stanford University

300 Pasteur Dr
Stanford, CA 94305
United States

Joel Nicholus

650-725-4612
nicholus@stanford.edu

Lorinda Chung, MD

John Hopkins Scleroderma Center

5501 Hopkins Bayview Cir
Baltimore, MD 21224
United States

Gwen Leatherman

410-550-8582
gleathe@jhmi.edu

Laura Hummers

Boston University Medical Center

1 Boston Medical Center Pl
Boston, MA 02118
United States

Christopher Zammitti

617-638-5383
zammitti@bu.edu

Robert W Simms, MD

Rutgers University

125 Paterson St
New Brunswick, NJ 08901
United States

Deborah McCloskey

732-418-8478
mcclosda@rwjms.rutgers.edu

Vivien Hsu, MD

Weill Cornell Medical College

1300 York Ave
New York, NY 10065
United States

Emily Bakaj

212-774-7620
bakaje@hss.edu

Robert Spiera

University of Pittsburgh Medical Center

1515 Locust St
Pittsburgh, PA 15219
United States

Dana Ivanco

412-648-7040
des2@pitt.edu

Robyn T Domsic, MD

University of Utah

50 N Medical Dr
Salt Lake City, UT 84132
United States

Jennifer Godina

801-581-4993
Jennifer.Godina@hsc.utah.edu

Tracy Frech, MD

University of Texas Houston Medical School

6431 Fannin, MSB 1150
Houston, TX 77030
United States

Patricia Gonzales

713-500-7118
patricia.gonzales@uth.tmc.edu

Maureen Mayes, MD