A new analysis that supports the effect of the diabetes vaccine Diamyd® will be presented at a scientific conference on 13 October

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The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

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Thursday, September 23, 2021
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ISPAD, Clinical trial, Diamyd Medical, International Society for Pediatric and Adolescent Diabetes, Hyperglycemia, GAD65, Society, Hannelius, ASHG, Diabetes, Patient, Type 1, Glycated hemoglobin, Eli Lilly and Company, Pediatrics, Continuous glucose monitor, International Society of Sculptors, Painters and Gravers, CEO, Blood, Meta-analysis, Company, Adolescence, Congress, Uppsala University Hospital, Human genetics, CGM, Hypoglycemia, Insulin, IIB, HLA, Nasdaq, EASD, Regeneration, Pharmaceutical industry
Geotags: 
Sweden, US, EUROPE
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DIAMYD MEDICAL AB
Summary
Key Points: 
  • The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.
  • Complete results will be submitted for publication in a scientific journal later this year.
  • The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production.
  • A vaccine manufacturing facility is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd.


A new analysis that supports the effect of the diabetes vaccine Diamyd® will be presented at a scientific conference on 13 October


STOCKHOLM, Sept. 23, 2021 /PRNewswire/ -- A new analysis that shows the effect of the diabetes vaccine Diamyd® (GAD-alum) in reducing the time a patient has high blood glucose, has been selected to be presented at the ISPAD conference (The International Society of Pediatric and Adolescent Diabetes), which this year will be held on 13-15 October. The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

The analysis shows that individuals with type 1 diabetes who carry the gene HLA DR3-DQ2, 15 months after study start, measured significantly shorter time with elevated blood glucose level (unadjusted p-value 0.0043) and significantly more time with normal blood glucose level (unadjusted p-value 0.0075) after treatment with Diamyd® than subjects treated with placebo. The presentation will be made on October 13 by Professor Johnny Ludvigsson and is entitled "Intralymphatic GAD-Alum (Diamyd®) improves hyperglycemia and glycemic control in Type 1 diabetes patients carrying HLA DR3-DQ2 - Exploratory analysis of continuous glucose monitoring data from the DIAGNODE-2 phase IIb clinical trial". Complete results will be submitted for publication in a scientific journal later this year.

The new results provide further support that the diabetes vaccine's effect in preserving endogenous insulin production also leads to an improved control of blood glucose levels. Previously reported results from a large-scale meta-analysis based on more than 600 individuals who participated in four placebo-controlled and randomized clinical trials with Diamyd® show significant positive effect of the diabetes vaccine both in maintaining the endogenous insulin-producing ability and in reducing blood glucose levels measured as HbA1c in individuals with the HLA haplotype DR3-DQ2.

At ISPAD, the design of the up-coming Phase 3 trial DIAGNODE-3 will also be presented,  in the form of an electronic poster, by Ulf Hannelius, CEO of Diamyd Medical. Hannelius will also make the same presentation at the virtual congress the American Society of Human Genetics (ASHG, October 18-22).

As previously announced, Ulf Hannelius will present a summary of the results of the Diamyd® meta-analys at the EASD diabetes conference on October 1, 2021. The EASD conference will be held virtually on September 27 - October 1, 2021.

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. Preparations for a confirmatory Phase III trial in the US and Europe are on-going, to start recruting patients later in 2021. 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 patients 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.

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: [email protected].

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: [email protected]

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