Therapy Areas: Autoimmune
Abcuro Initiates Registrational Phase 2/3 Study of ABC008 for the Treatment of Inclusion Body Myositis
6 April 2023 - - US-based clinical-stage biotechnology company Abcuro, Inc has initiated a registrational Phase 2/3 study of ABC008 in inclusion body myositis. ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells, the company said.

IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue causing patients to progressively lose muscle function, including loss of grip, dexterity, and mobility.

Muscle tissue from patients with IBM shows the presence of highly differentiated, KLRG1+ cytotoxic T cells destroying muscle fibers. There are currently no available disease-modifying treatment options for IBM.

In the Phase 1 trial, potent, durable, and dose-dependent depletion of CD8+KLRG1+ T cells, the most highly cytotoxic T cells, was observed.

At the dose levels being used in the Phase 2/3 trial, near complete depletion of blood target cells was observed at 28 days post injection.

The registrational Phase 2/3 trial will enroll more than 200 patients across 30 global sites. Additional details about the trial are available on ClinicalTrials.gov (NCT05721573).

ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing 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, T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies.

The US Food and Drug Administration has granted Orphan Drug Designation to ABC008 for the treatment of IBM.

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 and T cell large granular lymphocytic leukemia.
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