Andromeda Biotech Initiates DIA-AID 2, a Confirmatory Phase 3 Study using DiaPep277, for the Treatment of Type 1 Diabetes
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Andromeda Biotech Ltd. announced the initiation of its confirmatory phase III clinical study, DIA-AID 2 using DiaPep277®, Andromeda’s lead product, for the treatment of type 1 diabetes.
Enrollment of patients has begun in the US as part of a global trial which will be conducted at 100 medical centers in North America, Europe, and Israel. This confirmatory study will include 450 newly diagnosed type 1 diabetes patients 20-45 years of age. The study is double-blind, placebo-controlled with a treatment period of 24 months. The main goal of the study is to maintain the ability of the pancreas to secrete insulin in patients who receive treatment with DiaPep277® compared to the placebo group.
Shlomo Dagan, CEO of Andromeda commented, “We are very pleased to achieve this important milestone as part of our clinical development plan for DiaPep277®, which was accepted by the EMA and the FDA. Notably, the success of this study will enable us to obtain marketing approval of the drug in Europe and the USA.”