Analysis supporting treatment with Diamyd® published in peer-reviewed scientific journal
An article presenting analyses of Continuous Glucose Monitoring (CGM) data from the randomised, placebo-controlled Phase 2b trial DIAGNODE-2 that assessed three intralymphatic injections of the therapeutic diabetes vaccine Diamyd®, has been published in the peer-reviewed scientific journal The Journal of Clinical Endocrinology & Metabolism (JCEM).
As communicated on 23 September 2021, treatment with Diamyd® in individuals recently diagnosed with type 1 diabetes carrying HLA DR3-DQ2 led to statistically significant positive treatment effects on longer time in the glycemic target range (TIR), reduced time in hyperglycemia, and reduced increase in glucose variability over the 15-month study period compared to placebo-treated patients.
“These results are very important, as they show clinically meaningful effects of intralymphatic Diamyd on CGM outcomes that are of great importance to patients as they reflect the day-to-day challenges of managing their diabetes despite current best standard of care,” says Johnny Ludvigsson, Professor at Linköping University, Coordinating Investigator of DIAGNODE-2 and senior author of the publication, and continues: “The publication provides further support for the potential of a beta cell-preserving treatment such as Diamyd to positively impact patients’ lives on top of current diabetes care.”
The publication is entitled "Intralymphatic GAD-alum (Diamyd®) improves glycaemic control in Type 1 diabetes with HLA DR3-DQ2", and is expected to become freely accessible shortly in an Open Access version. A summary of the publication can be accessed at https://doi.org/10.1210/clinem/dgac343.
About Continuous Glucose Monitoring (CGM)
Continuous Glucose Monitoring means that patients carry a device and sensor that records 24-hour blood glucose which allows detailed analysis of intra-day glucose fluctuations. It is a complement to glycated hemoglobin HbA1c, which provides a 3-month average picture of glucose control. Longer time in the glycemic target range and reduced variability in blood glucose are associated with significant clinical benefits including lower risk of severe hypoglycemia and improved quality of life.
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 June 6, 2022, 17.45 CET.
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