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Corbus Pharmaceuticals Announces Topline Results from DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
Study did not meet primary endpoint of Total Improvement Score (TIS) at Week 28Additional findings included nominally significant improvements in TIS (p =
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Study did not meet primary endpoint of Total Improvement Score (TIS) at Week 28Additional findings included nominally significant improvements in TIS (p = 0.0302) and CDASI (p = 0.0166) depending on the dermatomyositis subtypeLenabasum treatment was safe and well-tolerated in this study Norwood, MA, June 24, 2021 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an immunology company developing innovative medicines that target inflammation, fibrosis, metabolism and immuno-oncology, today announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the rare, heterogeneous, autoimmune disease dermatomyositis. Primary endpoint: The study did not meet its primary endpoint of Total Improvement Score (TIS) at Week 28. Higher TIS values indicate greater overall improvement. At Week 28, the lenabasum 20 mg twice daily group achieved a mean TIS of 28.3 versus the control group mean TIS of 26.7, p = 0.1965. All subjects, including the control group, received standard background treatments, with 89% of dosed subjects receiving ≥ 1 immunosuppressive or immunomodulating therapy. Additional pre-specified analyses of the overall effect on TIS of lenabasum 20 mg twice daily versus control group through Week 52 showed a trend of beneficial effect of lenabasum, nominal p = 0.0795. Additional findings: Dermatomyositis patients have characteristic muscle weakness and inflammatory skin involvement. This study enrolled subjects with the two major types of dermatomyositis: classic dermatomyositis with both muscle weakness and skin involvement and dermatomyositis with no significant muscle weakness but with skin involvement. Improvement in muscle weakness is heavily weighted in the TIS score. In the overall study, higher TIS scores were seen in those subjects who had muscle weakness (Manual Muscle Test-8 muscle group score ClinicalTrials.gov Identifier: NCT02466243). Effect of lenabasum on lung function was a secondary endpoint in this study, and no statistically significant difference was seen at Week 28 in the lenabasum 20 mg twice daily group versus control group. In the overall study, other pre-specified analyses showed that subjects on stable immunosuppressive therapies (> 1 year treatment duration) had an improvement in forced vital capacity compared to the control grou...