Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) plunged 7.97% after the company’s topline results from the third phase DETERMINE lenabasum study in people with rare, heterogeneous autoimmune diseases dermatomyositis failed to meet the primary endpoint.
Lenabasum didn’t meet the primary endpoint
At Week 28, the study’s primary endpoint, the Total Improvement Score (TIS), was not met. Higher TIS levels indicate greater overall progress. At Week 28, the lenabasum 20 mg twice daily group had a mean TIS of 28.3 compared to 26.7 for the control group. Standard background treatments were given to all individuals, including the control group, with 89% of the dosed participants getting at least one immunomodulation/immunosuppressive therapy. Equally, more pre-specified analyses of the overall lenabasum 20 mg twice daily effect on TIS against the control group until Week 52 revealed a tendency of lenabasum benefit.
Patients with dermatomyositis experience inflammatory skin involvement and muscle weakness. The participants in this study had one of two forms of dermatomyositis: classic dermatomyositis, which includes both muscular weakness and skin involvement, and dermatomyositis, which does not include muscle weakness but does include skin involvement. Improvements primarily influence the TIS score in muscle weakness.
Lenabasum demonstrated favorable efficacy in stud group
The effectiveness of the lenabasum 5 mg twice daily group was comparable to that of the control group. Treatment-emergent adverse events (AEs) occurred in 86.5% of lenabasum-treated patients and 85.9% in the control group. Equally, severe AEs occurred in 11.5% of lenabasum-treated subjects and 5.6% in the control group. None of the lenabasum-treated subjects discontinued the study drug due to an AE related to the study drug.
Corbus Head of Research and Chief Medical Officer Barbara White, said, “We are disappointed that the trial did not meet the primary endpoint of TIS at Week 28. Nonetheless, we are encouraged by the results when the outcome is matched to the subtype of dermatomyositis in the study.”