Andromeda Biotech, an Israel-based biotechnology company, recently announced that its Phase 3 study of a novel immune therapy agent, DiaPep277, met its primary and secondary endpoints of insulin preservation and improvement in HbA1c levels among newly diagnosed people with type 1 diabetes (T1D). The goal of the trial is to find out if the novel peptide DiaPep277, could prevent the destruction of insulin-producing cells in the pancreas, thereby, slowing the progression of T1D.

DiaPep277, developed by Andromeda, is derived from the human Heat Shock Protein-60 (Hsp60), which is believed to have direct immune-modulating capabilities that may help diminish or block the autoimmune response to beta cells in T1D.

The Phase 3 study, DIA-AID1, was a 24-month randomized, placebo-controlled trial that involved 457 individuals recently diagnosed with T1D (within three months), and
ranged in age from 16-45 years old.  DiaPep277 and the placebo were administered on the first day of the trial, and every three months after. The last dose of the immune therapy was administered on the 21^st month.  The initial results show that patients who were treated with DiaPep277 were associated with higher levels of C-peptide secretion, when compared to the placebo group.  Measurement of C-peptide show how much insulin the body is producing.  It was also reported that a decline in C-peptide levels was more pronounced in the placebo group than in the treated group.

The study also achieved a key secondary endpoint, which showed that a higher proportion of the patients treated with DiaPep277 were able to maintain good control of their diabetes when compared to the placebo, as measured by HbA1c levels that were equal
to or less than 7% at the end of the study . HbA1c levels are a measure of metabolic control that reflects the amount of glucose in a patient’s blood over a three-month timeframe. Initial safety data also indicate that DiaPep277 was well tolerated, and no adverse effects were reported between the treatment and placebo groups.

According to the company, top-line results from the trial will be submitted for publication.

While positive, it is important to note that the results are still preliminary, and additional analyses of clinical, efficacy and safety
data are ongoing.  Furthermore, these results will need to be confirmed in the ongoing Phase 3 DiaPep277 DIA-AID2 trial in the United States, which involves subjects older than 20 years of age with new onset T1D.

As demonstrated by this trial, new insights into the workings of the immune system and how it interacts with beta cells have given
scientists an unprecedented vantage point from which to develop new immune therapies for T1D.  While JDRF did not fund this
particular trial, JDRF has made research into halting or reversing the autoimmune response that causes T1D a priority.  JDRF currently supports two dozen preclinical research programs and four clinical trials toward the discovery and development of vaccines and other strategies to prevent, halt, or reverse T1D.