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The company also announced that they expect to have review of the sentinel cohort safety data by an independent Data Safety Monitoring Board (DSMB) by the end of this year. The Phase 2/3 study is designed as a randomized, double-blind, placebo-controlled multicenter study. Upon favorable review by the DSMB, the study will progress with the main purpose of evaluating the efficacy, safety, and tolerability of two dose levels of ABC008 compared with placebo in subjects with
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, which attack and destroy muscle tissue in
'By completing enrollment of the sentinel group in the Phase 2/3 trial of ABC008 in
In the Phase 1 trial, of ABC008 in
'ABC008 was specifically designed with the potential to help patients with
About ABC008
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing naive, regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The
About ABC008 Phase 2/3 Study
The ABC008 Phase 2/3 study is a randomized, double-blind, placebo-controlled, parallel multicenter study with three parts. The registrational Phase 2/3 trial will enroll more than 200 patients across 30 global sites. Part A involves enrollment of a sentinel safety cohort in which subjects will undergo safety and tolerability review by a DSMB after 20 weeks of treatment. With a favorable DSMB review, the study will progress to Part B, with the main purpose of evaluating the efficacy, safety, and tolerability of two dose levels of ABC008 (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with
About Abcuro
Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T and NK cells. The company's lead program is ABC008 and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia.
Contact:
Christine Quern
Email: cq@christinequern.com
Tel: 617.650.8497
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