Diamyd Medical AB (publ) provided additional support for the saty and feasibibility of intralymphatic booster injections of Diamyd, showing only a small decline in stimulated endogeous insulin production one year following the additional injection and up to 8 years from type 1 diabetes diagnosis. On average, the six individuals that received a booster injection had stable and well-controlled blood glucose levels measured as HbA1c. Average stimulated C-peptide, a measure of endogenous insulin secretion, was 0.66nmol/L before the first Diamyd injection years ago, and now, one year following the booster injection, the decline was on average 0.03nmol/L. No serious adverse events were reported.

DIAGNODE-B is based on an earlier analysis of the DIAGNODE-1 trial, communicated on December 20, 2019, in which three patients received an additional intralymphatic Diamyd injection after the 30-month visit. That analysis showed preservation of own insulin production between the 30-month and 43-month visits. A follow-up analysis, communicated on August 26, 2021, showed that all three individuals who received an additional injection in DIAGNODE-1 carried the genetic HLA DR3-DQ2haplotype, a haplotype that has been associated with positive clinical response to Diamyd treatment and is carried by up to 40% of individuals diagnosed with type 1 diabetes.

The results were published in the peer-reviewed scientific journal Acta Diabetologica in January 2022. DIAGNODE- B is an open-label investigator-initiated clinical trial in Type 1 diabetes patients who carry the genetically defined haplotype HLA DR3-D Second Quarter and have previously been treated with intralymphatic injections of Diamyd. The trial includes six patiens who have either been treated with four injections in DIAGNode-1, who have received a 5th intralymphatic injection of Diamyd, or patients who participated in DIAGNODE-2, who have received a 4th intralymphatic injection the 4th intralymphatic injections ofDiamyd, approximately 4 years after the last injection.

The aim of the trial is to evaluate the safety of a booster (fourth/fifth) injection of Diamyd and the effect on the immune system and endogenous insulin production. The patients have been followed for 12 months after the additional injection. Sponsor of the trial is Linkping University with Professor Johnny Ludvigsson as the Sponsor's representative.

Diamyd Medical contributes with study drug, expertise and some financial support.