November 22, 2011
Andromeda announces Phase III Clinical Study with DiaPep277®, a Novel Immunotherapeutic Agent for Type 1 Diabetes, Met Primary Endpoint
DiaPep277® demonstrated a significant preservation of C-peptide levels, a marker for assessing insulin secretion by pancreatic cells
Higher proportion of patients maintained adequate diabetic control defined as serum HbA1c levels equal or less than 7%
Yavne, Israel, November 22, 2011 - Andromeda Biotech Ltd. announces initial results from a pivotal phase III clinical study. The 24-month study was randomized, placebo-controlled, designed to assess the safety and efficacy of DiaPep277®, a novel immunotherapeutic agent for the treatment of newly diagnosed patients with Type 1 Diabetes (T1D). The results from patients who were treated with DiaPep277® show that the study has met its primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study. Significant preservation of C-peptide levels, a marker for assessing endogenous insulin secretion by pancreatic cells, was demonstrated in patients treated with DiaPep277® compared to the placebo arm. The decline in C-peptide levels was more pronounced in the placebo arm than in the treated group. The difference between the arms reached 0.949 nmol/L/20 minutes, (p=0.0374). This difference reflects a relative preservation of 23.4% compared to placebo. Evaluation of the primary endpoint was performed on patients in the modified ITT population who have at least one measurement post baseline.
The study also achieved a key secondary endpoint, showing that a greater proportion of DiaPep277® treated patients maintained good diabetic control compared to the placebo, measured by HbA1c levels equal or less than 7% at the end of the study (45.5% versus 35.7%, p =0.035 ). Initial safety data also indicate that DiaPep277® was well tolerated. No major differences in drug-related adverse events were reported between the treatment and placebo groups.
Additional analyses of clinical, efficacy and safety data from this study are ongoing. A second confirmatory, global Phase III study with DiaPep277® is currently being conducted at about 120 medical centers in the USA, Canada, Europe, Israel and Argentina. Completion of patient recruitment for this study (450 patients) is anticipated by the first half of 2012.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) took an equity position in Andromeda following interim phase III study results, and has an exclusive worldwide license to the DiaPep277® product.
Prof. Itamar Raz, Head Diabetes Unit, Department of Medicine, Hadassah University Hospital, Jerusalem, Chairman of the Scientific Steering Committee of the study notes that “We are very pleased with these top-line results, which indicate an important breakthrough for medical science in the area of immune therapy for patients with Type 1 Diabetes. Preservation of the endogenous insulin secretion, which was corroborated by the clinical outcome of improved control of Hb1Ac, may fulfill the current vast unmet medical need in this field.”
Dr. Shlomo Dagan, CEO of Andromeda commented, “We are very excited about the prospect of DiaPep277® bringing new hope to newly diagnosed type 1 diabetes patients and their families, especially after other potential late stage products failed to show significant efficacy in immune intervention.”
About the Study
The phase III clinical study included 457 newly diagnosed Type 1 Diabetes patients aged 16-45, randomized into two study groups in a 1:1 ratio. The trial was conducted in 40 medical centers in Europe, Israel and South Africa. All patients recruited to the study received daily insulin therapy adjusted to their daily blood glucose levels. In addition, patients who were randomized in the treatment group were injected subcutaneously with 1 mg of DiaPep277® once every three months for two years. Subjects were evaluated for efficacy, defined as the ability to preserve insulin secretion, using the glucagon stimulation test and the mixed meal tolerance test. The target population for efficacy included subjects who entered the study according to the protocol inclusion and exclusion criteria and received at least 1 dose of study medication (modified ITT population), and have at least one measurement post baseline (338 patients, equally divided between the treated and placebo arms). Other clinical endpoints included glycemic parameters such as HbA1c, insulin daily dose requirement and the number of hypoglycemic events. Clinical and safety parameters were evaluated every three months throughout the two years of the study.
DiaPep277®, a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60 (Hsp60), was invented by Prof Irun Cohen and his team at the Weizmann Institute of Science. The peptide acts by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin, and preserving their natural function. Treatment of T1D patients with DiaPep277® may have several medical benefits including slowing the deterioration of the disease, improved metabolic control, reduction of daily insulin dose requirements, and reduction of diabetic complications.
To date, there is no therapy able to slow the progressive destruction of insulin secreting pancreatic beta cells in T1D. Initially, DiaPep277® is targeted to treat newly diagnosed T1D adult patients with residual insulin secreting cells. Additional target populations include newly diagnosed children with T1D, patients with a high risk of developing T1D, and T1D patients with slow progressing disease.
Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI) is focused on the development of an innovative treatment for autoimmune diabetes. Andromeda’s DiaPep277®, currently in Phase III Clinical Studies, is a novel therapeutic approach to treat T1D.
For more information about Andromeda Biotech please visit our site: (www.andromedabio.com) or contact:
Shlomo Dagan, PhD
Andromeda Biotech Ltd.
Phone: +972 8 938 7777