Diamyd’s diabetes vaccine found effective in Phase IIb study

The 30 month results comprise the final timepoint for the now-completed Diamyd study. Positive results have previously been reported after 15 and 21 months. The Phase IIb study with the Diamyd therapeutic diabetes vaccine met its primary endpoint regarding preservation of beta cell function as measured by C-peptide, a marker for the body’s natural insulin production. The clear positive effect of Diamyd on preservation of beta cell function is also accompanied by a significant and specific immune response, an additional important factor in evaluating the effectiveness of the therapy since it is believed Diamyd acts by modifying the patient’s immune system.

The Diamyd study, which was conducted at 8 clinical sites in Sweden, included 70 patients aged 10-18 who had been diagnosed with type 1 diabetes within 18 months. 35 patients received two single injections of Diamyd and 35 patients received placebo. The newly-presented data showed that 30 months after the first injection, the Diamyd-treated group showed statistically significant better preservation of insulin secretion, both in fasting state and after meal stimulation, compared to placebo. This indicates that Diamyd has successfully protected the beta cell function. The protective effect remains most pronounced in patients treated early after disease diagnosis.

Elisabeth Lindner, CEO and president of Diamyd Medical, said: “The plan is now to commence Phase III studies in order to confirm the positive results and then to apply for registration of the product.”