T1DAL 2-Year Clinical Results

June 2, 2014

The recently available 24-month data from the ITN’s T1DAL study (Inducing Remission in New Onset T1DM with Alefacept (Amevive®)) show a statistically significant benefit in C-peptide preservation in the alefacept-treated group (N=33) compared to the controls (N=16). At 24 months the alefacept group had an average C-peptide decline of 0.134 pmol/mL from baseline (using a 4 hour AUC), compared to the control group who had an average decline of 0.368 pmol/mL (p=0.002). Compared to placebo, the alefacept group also had significantly lower daily insulin use (p=0.005) and experienced a lower rate of hypoglycemic events (p<0.001).

Although the two year data are a secondary endpoint for this study, these positive results are very exciting and confirm the potential for C-peptide preservation with this well-tolerated drug. The team will review flow data in the coming weeks to potentially bolster the clinical results with a mechanistic story. Thanks to the team for their hard work in collecting and analyzing this data.

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