Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) stock fell by 11.31% during the current trading session. By expanding on their core knowledge in immunology, Corbus is committed to linking innovation to their goal of helping lives by discovering novel medications that address inflammation, fibrosis, metabolism, and immuno-oncology.
What is happening?
Corbus Pharmaceuticals Holdings released the topline findings from the Phase 3 DETERMINE trial of lenabasum in people with the uncommon, heterogeneous autoimmune illness dermatomyositis.
At Week 28, the report’s primary objective of Total Improvement Score was not met. Greater overall progress is indicated by higher TIS scores. 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, p = 0.1965. Standard background therapies were given to all participants, including the control group, with 89 percent of dosed subjects getting at least one immunosuppressive or immunomodulating medication. Additional pre-specified evaluations of the overall impact of lenabasum 20 mg twice daily on TIS vs the control group until Week 52 revealed a tendency of lenabasum benefit, nominal p = 0.0795.
Patients with dermatomyositis experience muscular weakness and inflammatory skin involvement. The participants in this research had one of two kinds 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.
Treatment-emergent side effects have been reported in 86.5 percent of lenabasum-treated patients and 85.9% of control subjects, according to safety statistics. Serious AEs occurred in 11.5 percent of lenabasum-treated individuals and 5.6 percent of control subjects, with no lenabasum-treated subject and one control subject discontinuing study treatment due to a study drug-related AE.
Yuval Cohen, Ph.D., Chief Executive Officer, stated,
The findings from the Phase 2 and Phase 3 dermatomyositis trials will be discussed with regulatory bodies, and their opinion on the next actions will be sought. They have the resources to pursue their now-diversified pipeline while also considering future moves for lenabasum owing to their solid financial position.