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news.Biopharmceutical firm TolerRx has initiated three new clinical trials investigating both its lead product candidate for autoimmune diseases TRX4 and its collaborative investigational compound TRX1, being developed with the help of Genentech.
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The first is a follow-on study of TRX4 in subjects with type 1 diabetes. Previous phase I studies have shown TRX4 can preserve the function of insulin-producing beta cells in the pancreas and reduced the amount of administered insulin needed to control blood glucose levels in diabetes. The new study will be performed to find the optimum dose of TRX4 to be used in later-stage trials.
The next study, a phase Ib study of TRX4, will be in subjects with moderate to severe psoriasis. The trial will evaluate the safety and efficacy of escalating multiple doses of the drug. A previous study has shown the drug to be safe, although efficacy was not evaluated as a primary endpoint.
The third phase Ib study will evaluate TRX1 in subjects with refractory cutaneous lupus erythematosus (CLE). In preclinical studies, TRX1 therapy has been shown to induce long-term, antigen-specific tolerance without compromising normal immune function. The current trial will evaluate the safety and efficacy of multiple escalating doses of TRX1.
“TRX4 and TRX1 may have the potential to provide a long-term benefit after only a short course of therapy, something that both physicians and patients would welcome,” said Lou Vaickus, chief medical officer at TolerRx.