Product
TRX4
Licensee
Tolerx, Inc
Indication
Type 1 diabetes, psoriasis
Phase
Phase III – type 1 diabetes
Phase I – psoriasis
Description
Humanised monoclonal antibody that binds to the CD3 receptors on T cells and is designed to block the function of autoreactive T-effector cells that attack the body and cause autoimmune diseases.
Further Information
Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing cells of the pancreas. Diet, exercise and the administration of insulin are used to manage the condition, but there are no current therapies that prevent the underlying cause of the condition, which is the loss of beta cell function resulting from an autoimmune attack.
TRX4 halts the immune system attack on the beta cells, thereby allowing them to continue to produce natural insulin. In an 80-patient Phase II study it was demonstrated that in patients with new-onset type 1 diabetes, a six day course of therapy with TRX4 preserves the function of insulin-producing beta cells in the pancreas and reduces the amount of administered insulin needed to control blood glucose levels for at least 18 months.
At 6, 12, and 18 months, beta cell function was more effectively maintained in TRX4-treated subjects than in placebo-treated subjects as assessed by C-peptide release. Daily insulin dose increased in the placebo group, but not in the TRX4 group.
Tolerx initiated a pivotal Phase III trial of TRX4 in patients with new onset Type 1 diabetes in
August 2008.
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