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Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) on Wednesday announced that a Phase 3 trial for their blockbuster asthma therapy Dupixent for a skin condition known as bullous pemphigoid succeeded, while another for a long-term itching condition failed.
Citing data from their 106-subject ADEPT pivotal trial, the companies said the interleukin-targeting monoclonal antibody met the primary and all key secondary endpoints in adults with moderate-to-severe BP.
A skin disease characterized by severe itch and blisters, bullous pemphigoid can be fatal due to the risk of infection.
As for the primary goal in ADEPT, 20% of those on Dupixent witnessed sustained disease remission at 36 weeks compared to 4% on placebo. Results for secondary endpoints, such as ≥90% reduction in disease severity and clinically meaningful itch reduction, were also statistically significant.
Regarding safety, 96% on Dupixent and a similar proportion on placebo witnessed adverse events. While there were no adverse events leading to death in the Dupixent group, two AEs in the placebo group led to death.
“We look forward to further advancing this research and sharing the positive results from the bullous pemphigoid pivotal trial with regulatory authorities,” said Regeneron’s (REGN) science chief, George Yancopoulos.
Additionally, Regeneron (REGN) and Sanofi (SNY) updated investors on their Phase 3 program for Dupixent in chronic pruritus of unknown origin (CPUO) which comprises two separate late-stage trials called Study A and Study B.
The companies said that small Study A for adults with uncontrolled and severe CPUO did not reach statistical significance in its primary itch responder endpoint. Study B is expected to begin as a subsequent pivotal trial. In Study A, Dupixent indicated a safety profile consistent with its established safety profile.
More on Regeneron Pharmaceuticals, Sanofi, etc.
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