Phase 2 Study
Phase 2 Dermatomyositis Trial (Completed)
Corbus has reported positive topline data demonstrating that lenabasum had a mean improvement (reduction) in the primary efficacy outcome, the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score, a validated outcome measure of skin disease severity, was 9.3 points for lenabasum treatment at the end of the study versus a reduction of 3.7 points for placebo treatment (p = 0.04) in patients with skin-predominant dermatomyositis.
The single center, double-blind, randomized, placebo-controlled trial enrolled 22 adult subjects in a 1 to 1 ratio of lenabasum to placebo cohorts. At baseline, subjects in each cohort had a mean CDASI activity score in the severe range and skin symptoms in the extremely severe range despite background treatment with immunosuppressive drugs in 19 of the 22 subjects. Demographic parameters, CDASI activity scores, patient-reported outcomes, and use of immunosuppressive drugs at baseline were similar for lenabasum and placebo cohorts. Subjects received lenabasum 20 mg QD through week 4, then lenabasum 20 mg BID through week 12 with safety and efficacy follow-up thereafter through week 16. All subjects remained on their background standard-of-care therapy throughout the study.
Primary Efficacy Endpoint
Improvement in CDASI activity scores in the lenabasum cohort were ≥ 7.5 points and consistently superior to improvement in the placebo cohort from week 6 to end of study. The mean improvement (reduction) in CDASI activity score for the lenabasum cohort (20 mg QD followed by 20 mg BID) from day 1 to end of study was 9.3 points versus 3.7 points for the placebo cohort (p = 0.04, 2-sided MMRM). The greater degree of improvement versus placebo in CDASI activity score occurred during dosing with lenabasum 20 mg BID (treatment effect 6.3 points at end of study, p = 0.02, 2-sided MMRM). Improvement in CDASI activity score ≥ 4 points has been correlated with improvement in patient-reported quality of life outcomes, pain and physician global assessment.
Secondary Efficacy Endpoints and Safety Outcomes
Improvements across multiple secondary efficacy outcomes were seen in the lenabasum cohort versus the placebo cohort, including statistically significant improvement in CDASI Damage Index (p = 0.04) and patient-reported symptoms and functioning. Lenabasum was well tolerated and demonstrated a favorable safety profile with no serious or severe side effects related to the study drug and no study discontinuations.
Data Selected for Late Breaking Presentation at ACR
Detailed results of safety and primary and secondary efficacy assessments have been selected for a late-breaking poster presentation entitled "A Phase 2 Study of Safety and Efficacy of Lenabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist, in Refractory Skin-Predominant Dermatomyositis" on November 7, 2017 at 9:00 -11:00 AM PDT at the American College of Rheumatology ("ACR") Annual Meeting being held November 3-8 in San Diego, CA. Demographics and baseline characteristics of subjects will be presented in a second poster presentation (abstract 2156) entitled: "Comparison of Patients with Dermatomyositis in a Specialty Clinic Versus Clinical Trial with Lenabasum (JBT-101), a Cannabinoid Receptor Type 2 Agonist."
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