Diamyd® Phase IIb trial results published in Diabetes Care
STOCKHOLM, May 21, 2021 /PRNewswire/ -- Diabetes Care has published the results of DIAGNODE-2, a Phase IIb trial that evaluated intralymphatic administration of Diamyd, Inc. Medical's lead drug candidate Diamyd® (GAD-alum) in individuals recently diagnosed with type 1 diabetes. Results showed, in line with a published large-scale metaanalysis of clinical data, that while no treatment benefit was seen in the full patient population, three intralymphatic injections of Diamyd® had a significant and positive effect on the preservation of insulin producing capacity in the predefined subgroup of individuals that carry the HLA DR3-DQ2 haplotype. In this subgroup of patients, more than 50% greater preservation of insulin producing capacity was observed at 15 months from baseline in those that received active treatment compared to placebo.
"We are proud to have the results from DIAGNODE-2 published in this leading diabetes journal", says Ulf Hannelius, CEO of Diamyd Medical. "The peer-reviewed publication provides important support for the notion that there is a well-defined group of individuals with type 1 diabetes that will benefit from precision treatment with the diabetes vaccine Diamyd®".
The article entitled "Intralymphatic glutamic acid decarboxylase with Vitamin D supplementation in recent onset Type 1 diabetes: a double-blind randomized placebo-controlled Phase IIb trial", showed that the primary endpoint of change in stimulated serum C-peptide was not met in the full analysis set of 109 individuals (treatment effect ratio 1.091, CI 0.845-1.408, p = 0.5009). However, in the predefined subgroup of individuals carrying HLA DR3-DQ2 (n=29), GAD-alum showed greater preservation of stimulated C-peptide (treatment effect ratio 1.557, CI 1.126-2.153, p = 0.0078) after 15 months compared to placebo treated individuals with the same genotype (n=17). Several secondary end points showed supporting trends and a positive effect was seen in terms of partial disease remission (IDAA1c≤9, p=0.0310). The results also show that HLA influences the immunological response to GAD-alum, the major consituant of Diamyd®. As expected with most vaccination efforts, minor transient injection site reactions were reported.
"DIAGNODE-2 has been integral to evaluate the safety and efficacy of intralymphatic injections of GAD-alum as well to prospectively evaluate the influence of HLA regarding the clinical and immunological effect of GAD-alum", says Johnny Ludvigsson, Professor at Linköping University. "There is a great unmet medical need in type 1 diabetes and with these data, superior safety profile and convenient treatment regimen, GAD-alum treatment shows strong promise in being able to change the treatment paradigm for this disease".
"This is an important milestone for the field of type 1 diabetes and a great example on the importance of merging scientific advances and insights with clinical development and data", says Mark Atkinson, Ph.D., Director of the Diabetes Research Institute at the University of Florida and Diamyd Medical Board Member. "Diligence and persistence with antigen specific therapies will bear fruit, and the notion that a precision vaccine approach, based on genetic markers, is the way forward to make a difference for type 1 diabetes".
The publication is available online at https://care.diabetesjournals.org/lookup/doi/10.2337/dc21-0318 and will later be published in an upcoming issue of the journal.
About Diamyd Medical
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Company Codes: ISIN:SE0005162880, Stockholm:DMYD-B