Uppsala University Hospital's ReGenerate-1 trial evaluating Diamyd Medical's Remygen® in individuals with long-term Type 1 Diabetes met the primary endpoint of safety. No clear support for a durable treatment effect on increasing endogenous insulin production measured as C-peptide or preventing hypoglycemia (sharply lowered blood glucose levels) by improving the protective counterregulatory hormonal response was observed. A potential trend for an immediate effect, e.g directly following ingestion of Remygen®, on improving counterregulatory hormonal responses was observed in the higher dose groups.

The primary endpoint in ReGenerate-1 was safety and the main secondary endpoints evaluated the treatment effect on the hormonal counter-regulatory response to low blood sugar and on the restoration of beta cell function measured as stimulated C-peptide. The trial participants' responses to hypoglycemia were evaluated with a hyperinsulinemic hypoglycemic clamp, which means that the blood glucose is lowered under controlled forms and the body's hormonal response is measured. The topline results include full data from up to nine months of follow- up from 26 study participants assigned to one of three study arms: low-dose Remygen®, high-dose Remygen®, or high-dose Remygen® combined with low-dose Alprazolam.

No safety concerns where reported in the trial. No durable effect of Remygen® regarding increasing secretion of the hormones glucagon, adrenaline, growth hormone and cortisol during hypoglycemia was observed, indicating no apparent durable disease-modifying effect of the treatment. However, a potential trend for an immediate effect in the higher dose groups was observed on improving the counterregulatory hormonal response during hypoglycemia.

Treatment with Remygen® did not indicate a clear effect in terms of increasing endogenous insulin producing capacity measured as stimulated C-peptide. This said, individuals with some detectable insulin producing capacity at baseline retained their C-peptide for the duration of the trial. Individuals that had no detectable insulin producing capacity at baseline did not see a measurable increase in C-peptide during the trial.

Additional results pertaining to blood glucose control measured as HbA1c, Time in Range measured using continuous glucose monitoring and immunological markers, are expected in the coming weeks.