Diamyd® for LADA

Diamyd® for LADA has reached Phase II in clinical trials, and the company is now reviewing the potential to license the product on a regional and/or global basis.

Various doses of the vaccine were tested in a randomized double-blind placebo-controlled Phase II study with 47 LADA patients. Depending on study arm, the patients received two injections with a four-week interval of 4, 20, 100 or 500 µg Diamyd® or placebo. The study was unblinded after six months and the patients were followed for another four and a half years. The study results demonstrate that the best dose of Diamyd® is 20 µg. A five year follow-up of the participants showed that the risk that a LADA patient will need to begin insulin treatment is significantly reduced after treatment with Diamyd®. Only 14 percent of the patients in the group that received 20 µg of Diamyd® needed insulin after five years following the initial injection, versus 64 percent in the placebo group. No serious side effects from Diamyd® were reported during the five-year period. The results were presented at a conference organized by the European Association for the Study of Diabetes (EASD) in September 2008.

Safety data from a Phase II study of Diamyd® for LADA with 160 LADA patients were collected after 30 months of follow-up. The efficacy data were invalidated in 2007 due to suspected mislabeling of the investigational drug.

No serious side effects related to Diamyd® treatment have been reported in any study, which additionally strengthens the safety profile of the Diamyd® therapeutic diabetes vaccine.