All patients in DIAGNODE-B have received an additional (booster) injection of Diamyd®

The last patient in the investigator-initiated clinical trial DIAGNODE-B has received its additional injection ("booster") of the therapeutic diabetes vaccine Diamyd^®. The trial includes 6 patients with Type 1 diabetes who earlier participated in the DIAGNODE-1 or DIAGNODE-2 trials and who carry the genetic HLA DR3-DQ2 haplotype. DIAGNODE-B (B for "booster") assesses the safety, immunological response and clinical effect of an additional intralymphatic injection of Diamyd^®. Patients will be followed for 12 months after the booster injection and topline results are expected in the fourth quarter of 2023.

"This is an exciting and important trial that will provide insights into the therapeutic effect and the commercial potential of the diabetes vaccine Diamyd," says Ulf Hannelius, CEO of Diamyd Medical. "The assessment of a booster injection in the patient population with HLA DR3-DQ2 will provide valuable information about the potential to prolong or reinforce the effect on the preservation of the body's own insulin production. A prolonged effect with a booster injection would mean clear competitive advantages by supporting both the pricing and reimbursement strategy for treatment with Diamyd if marketing authorization is obtained, and by making it possible to treat even more patients."

"The good safety and efficacy of three intralymphatic injections amongst patients who carry HLA DR3-DQ2 are a great advantage of Diamyd and make the evaluation of a booster injection particularly interesting," says Johnny Ludvigsson, Professor at Linköping University and Sponsor of the trial. "In our first trial with intralymphatically administered Diamyd, DIAGNODE-1, all three individuals who received a fourth injection preserved their own insulin production over at least one additional year, which is remarkable."

The patients who are enrolled in DIAGNODE-B have earlier been treated with three or four intralymphatic injections of Diamyd^® in the DIAGNODE-1 or DIAGNODE-2 trials. All patients carry the genetically defined HLA DR3-DQ2 haplotype which is associated with significant and clinically meaningful treatment effects of Diamyd^®.

DIAGNODE-B builds 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-DQ2 haplotype. The results have been published in the peer-reviewed scientific journal Acta Diabetologica in January 2022 (https://doi.org/10.1007/s00592-022-01852-9).

The ongoing, confirmatory, pivotal Phase 3 trial DIAGNODE-3 assesses the effect of Diamyd^® in patients with recently diagnosed Type 1 diabetes who are positive for HLA DR3-DQ2. The recently completed GADinLADA trial with intralymphatically administered Diamyd^® showed promising results in patients with the autoimmune form of diabetes in adults, LADA (Latent Autoimmune Diabetes in Adults), who were positive for HLA DR3-DQ2.

About DIAGNODE-B
DIAGNODE-B is an open-label investigator-initiated clinical trial in Type 1 diabetes patients who carry the genetically defined haplotype HLA DR3-DQ2 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 now receive a 5th intralymphatic injection of Diamyd^®, or patients who participated in DIAGNODE-2, who have now received a 4th intralymphatic injection of Diamyd^®, 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 will be followed for 12 months after the additional injection. The trial will be conducted at the Clincal Resarch Unit at the University Hospital in Linköping. Sponsor of the trial is Linköping University with Professor Johnny Ludvigsson as the Sponsor's representative. Diamyd Medical contributes with study drug, expertise and some financial support.

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.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: [phone]
E-mail: [e-mail]

Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: [phone], Fax: [phone]
E-mail: [e-mail] Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on September  29, 2022, 16.00 CET.

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