Regeneron Advances Anticoagulant Antibody Pair to Late-Stage Testing
Regeneron's Advance:
Regeneron is advancing two Factor XI antibodies, REGN7508 and REGN9933, into a broad Phase 3 program following positive Phase 2 proof-of-concept results1.
Clinical Settings:
These antibodies are being evaluated for their potential to control thrombosis while minimizing bleeding risk in various patient populations and clinical settings, including after total knee replacement1.
Phase 2 Results:
Single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects compared to current standards of care, enoxaparin and apixaban1.
VTE Incidence:
REGN7508 was superior to enoxaparin and non-inferior to apixaban in reducing venous thromboembolism (VTE) rates, while REGN9933 was non-inferior to enoxaparin1.
Safety Profile:
There were no major bleeding events or clinically relevant non-major bleeding in any arm, and no treatment-related serious adverse events (SAEs) or deaths1.
Phase 3 Program:
The Phase 3 program is expected to be initiated in 20251.
Regeneron's Technology:
Regeneron uses its VelociMab and VelocImmune platforms to efficiently produce and optimize fully human antibody medicine candidates2.
Thrombosis Background:
Thrombosis is a significant clinical concern, and the development of anticoagulant therapies that minimize bleeding risk is crucial1.
Sources:
1. https://investor.regeneron.com/news-releases/news-release-details/regeneron-advance-two-factor-xi-antibodies-broad-phase-3-program