“DIAGNODE-3 is the result of years of hard work, important scientific advances and meticulous planning, and the fact that the first clinic has opened for patient recruitment is of course a significant milestone,” says Ulf Hannelius, CEO of Diamyd Medical. “A number of clinics in several countries in Europe will open shortly and we are working full time to further expand the trial in Europe to keep the time frame.”

“It is very gratifying that we now have started this crucial diabetes trial,” says Johnny Ludvigsson, Professor at Linköping University and Coordinating Investigator for DIAGNODE-3. “The trial, with its precision medicine approach, is unique in its kind and the start means a lot for Type 1 Diabetes.”

Once a clinic has opened, the inclusion of trial participants can begin. DIAGNODE-3 is approved in Sweden, the Netherlands, Spain, Poland and the Czech Republic. In Germany, the trial is approved for adult patients. More clinics in these countries will open in the coming weeks and work is underway to gradually increase the number of participating European countries and clinics. Work is also on-going to resolve questions from the US Food and Drug Administration (FDA) with the goal of being able to include US clinics in DIAGNODE-3.

About DIAGNODE-3
The Phase III trial DIAGNODE-3 with the diabetes vaccine Diamyd^® will enroll approximately 330 individuals aged 12 to 29, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd^®. A further stratification for HLA haplotypes will be included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.

DIAGNODE-3  will be conducted at approximately 50 clinical sites. Following a run-in period where all subjects receive vitamin D for one month, subjects will be randomized 2:1, i.e. two of three study participance will receive three intralymphatic injections of Diamyd^® and one of three will receive matching placebo given one month apart, with a primary efficacy readout at 24 months after all patients have been included. The design provides, based on efficacy data from previous trials on the HLA restricted patient population, a high probability to reach its primary endpoints:  1) preservation of endogenous insulin producing capacity and lower HbA1c. The coordinating investigator for the trial is Professor Johnny Ludvigsson at Linköping University. The sponsor of the trial is Diamyd Medical.

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd^® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. DIAGNODE-3, a confirmatory Phase III trial is on-going. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd^®. Diamyd Medical also develops the GABA-based investigational drug Remygen^® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen^® trial in individuals living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as in the artificial intelligence company MainlyAI AB.

Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on  March 15, 2022, 18.30 CET.