Fortress Biotech (NASDAQ:FBIO) announces that Caelum Biosciences in collaboration with Alexion Pharmaceuticals (NASDAQ:ALXN) have initiated the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, an amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis, a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow that leads to heart and kidney damage.
Caelum, founded by Fortress, collaborated with Alexion in 2019, under which ALXN acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity based on Phase 3 CAEL-101 data.
The CARES clinical program includes two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one with Mayo stage IIIb disease – and will collectively enroll ~370 patients globally.
Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival and the safety and tolerability of CAEL-101.
Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures and cardiac improvement.
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