STOCKHOLM, May 21, 2021 / PRNewswire / – Diabetes Care has released results from DIAGNODE-2, a Phase IIb study investigating the intralymphatic administration of Diamyd Medical’s lead drug candidate Diamyd® (GAD alum) in people who recently diagnosed with type 1 diabetes. The results, consistent with a published large-scale meta-analysis of clinical data, showed that three intralymphatic injections of Diamyd® had a significant and positive effect on the maintenance of insulin production capacity in the patient population, although no treatment benefit was found in the overall patient population, although no treatment benefit was found in the predefined subset of people, who carry the HLA DR3-DQ2 haplotype. In this subset of patients, more than 50% higher retention of insulin production capacity was observed in patients who received active treatment compared to placebo, 15 months after the start of the study.
“We are proud to have published the results of DIAGNODE-2 in this leading diabetes journal,” said Ulf Hannelius, CEO of Diamyd Medical. “The peer-reviewed publication provides important support for the belief that there is a well-defined group of people with type 1 diabetes who will benefit from precision treatment with the diabetes vaccine Diamyd®.”
The article, titled “Intralymphatic Glutamic Acid Decarboxylase with Vitamin D Supplementation in Recent Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled, Phase IIb Study” showed that the primary endpoint of change in stimulated serum C – Peptides in the study were not achieved in full analysis set of 109 people (treatment effect ratio 1.091, CI 0.845-1.408, p = 0.5009). However, in the predefined subset of people who carried HLA DR3-DQ2 (n = 29), GAD alum showed greater conservation of the stimulated C-peptide after 15 months (treatment effect ratio 1.557, CI 1.126-2.153, p = 0.0078) compared to placebo-treated subjects with the same genotype (n = 17). Several secondary endpoints showed supportive trends and a positive effect was observed in relation to partial disease remission (IDAA1c ≤ 9, p = 0.0310). The results also show that HLA influences the immunological response to GAD alum, the main component of Diamyd®. As expected with most vaccination efforts, minor transient injection site reactions have been reported.
“DIAGNODE-2 was an integral part of evaluating the safety and efficacy of intralymphatic injections of GAD alum as well as prospective assessment of the impact of HLA on the clinical and immunological effects of GAD alum,” says Johnny Ludvigsson, professor at Linköping University. “There is a huge unmet medical need in type 1 diabetes. With these data, superior safety profile and convenient treatment regimen, GAD alum treatment shows promise in changing the treatment paradigm for this disease.”
“This is a major milestone in the field of type 1 diabetes and a good example of the importance of combining scientific advances and insights with clinical development and data,” said Mark Atkinson, Ph.D., director of the Diabetes Research Institute at the University of Florida and Diamyd Medical Board Member. “Diligence and persistence in antigen-specific therapies will bear fruit, and the idea that a precision vaccine approach based on genetic markers is the way to make a difference in type 1 diabetes.”
The paper is available online at https://care.diabetesjournals.org/lookup/doi/10.2337/dc21-0318 and will be published later in an upcoming issue of the journal.
About DIAGNODE-2 The placebo-controlled study DIAGNODE-2 enrolled 109 patients from Spain, the Czech Republic, Sweden and the Netherlands, aged 12 to 24 years. Patients recently diagnosed with type 1 diabetes were given the diabetes vaccine Diamyd® (or its placebo) three times, one month apart, in combination with oral vitamin D (or its placebo) directly in the lymph nodes for four months administered starting 30 days before the first injection. The patients were followed for 15 months to assess the remaining insulin production capacity. In addition to evaluating efficacy in the overall patient population, individuals bearing the HLA DR3-DQ2 haplotype are pre-defined as a specific subgroup for the safety and efficacy assessment, based on data from three previous placebo-controlled studies that suggest a significant impact of HLA the HLA indicate the effectiveness of Diamyd®. Starting in autumn 2019, patients who had not yet completed their last visit after 15 months were offered to participate in an extension of the study for a further 9 months. The coordinating investigator is Professor Johnny Ludvigsson from Linköping University. The study is sponsored by Diamyd Medical. More information about the study can be found at www.diagnode-2.com
About Diamyd MedicalDiamyd Medical develops precise medical therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy to maintain endogenous insulin production. Significant results were shown in a genetically predefined group of patients in a large-scale meta-analysis, as well as in the company’s European Phase IIb study DIAGNODE-2, in which the diabetes vaccine was administered directly into a lymph node in children and young adults with the recently diagnosed type -1 diabetes. Preparations are underway for a confirmatory phase III study in the US and Europe to begin patient enrollment later in 2021. A new facility for the production of vaccines for the production of recombinant GAD65, the active ingredient of the therapeutic, is being set up in Umeå, the diabetes vaccine Diamyd®. Diamyd Medical is also developing the GABA-based test preparation Remygen® as a therapy to regenerate endogenous insulin production and to improve the hormonal response to hypoglycemia. A research-initiated Remygen® study is currently being carried out at Uppsala University Hospital in patients who have had type 1 diabetes for more than five years. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB.
Diamyd Medical’s B share is listed on the Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the company’s certified consultant. Phone: +46 8-528 00 399, email: info@fnca.se.
CONTACT:
For further information please contact: Ulf Hannelius, President and CEO: +46 736 35 42 41 Email: ulf.hannelius@diamyd.com
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