Abcuro has commenced a registrational Phase ll/lll trial of ABC008 for the treatment of inclusion body myositis (IBM).
ABC008 is an anti-KLRG1 antibody that has been designed to selectively reduce highly cytotoxic T cells without harming regulatory and central memory T cells.
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IBM is an autoimmune disease where highly cytotoxic T cells continuously attack muscle tissue, thereby causing patients to gradually lose muscle function, such as loss of grip, dexterity and mobility.
In a Phase l study, Abcuro observed potent, durable, and dose-dependent reduction of CD8+KLRG1+ T cells, the most highly cytotoxic T cells.
The dose levels of the Phase ll/lll study showed 97% depletion of blood target cells at 28 days after injection.
This trial will include over 200 patients across 30 sites worldwide.
The randomised, double-blind, placebo-controlled, parallel multicentre trial will be carried out in three phases.
Abcuro chief medical officer Jeffrey Wilkins said: “This registrational Phase ll/lll trial represents an important milestone for patients with IBM.
“It builds upon the compelling proof of mechanism observed with ABC008 to potently and selectively deplete highly cytotoxic T cells which attack and destroy muscle tissue in IBM, without affecting protective T cell populations.
“This approach differentiates ABC008 from broad T cell depleters whose use has been limited by adverse effects associated with broad immune-cell depletion.”
