STOCKHOLM, Nov. 6, 2024
STOCKHOLM, Nov. 6, 2024 /PRNewswire/ -- (IDS) Congress in Bruges, Belgium. The analysis will be presented at a Satellite Symposium organized by Abbott. The results support the robustness of the treatment effects and underscore the potential for precision medicine to slow and delay disease progression in Type 1 Diabetes.
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"These analyses clarify the robustness of our previous treatment results across trials in our genetically defined responder patient group, and further characterize the effect of DiamydŽ on glycemic control", says Ulf Hannelius, CEO of Diamyd Medical. "These insights together with the benign safety profile are central for positioning DiamydŽ as a best-in-class immunotherapy and in our preparations ahead of a potential accelerated approval by the U.S. FDA."
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Summary of the detailed breakdown of the previously published meta-analysis that included data from 627 patients, with a focus on DR3-DQ2 positive patients and high dose (3 or 4 injections) group where available:
These results demonstrate the effectiveness of DiamydŽ compared to placebo on preservation of C-peptide across individual trials and support the robustness of the currently ongoing confirmatory Phase 3 trial DIAGNODE-3. DIAGNODE-3 is designed to confirm the efficacy and safety of 3 intralymphatic injections of Diamyd or placebo in approximately 300 recent-onset T1D individuals ages 12-28 who are positive for HLA DR3-DQ2. An earlier readout to support a potential accelerated Biologics License Application with C-peptide preservation as the primary endpoint, including approximately 170 patients followed for 15 months, is expected around March 2026.
The presentation also includes insights from glucose monitoring data from the DIAGNODE-2 data, where the strongest correlation between treatment effect and glycemic control is seen for time in glycemic target range, time above the target range, number of severe hyperglycemic episodes and duration of hyperglycemic episodes. In addition to previously published treatment, the data show that DiamydŽ significantly lowers both the number, duration and amplitude of hyperglycemic excursions.
The insights will be presented by Anton Lindqvist, Chief Scientific Officer at Diamyd Medical during a Satellite Symposium organized by Abbott. The presentation is entitled:
"DiamydŽ Immunotherapy to Preserve ß-Cell Function and Improve Glycemic Control in Type 1 Diabetes Patients with HLA DR3-DQ2".
About Diamyd MedicalDiamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). DiamydŽ is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase 3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial, where DiamydŽ was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy DiamydŽ. Diamyd Medical also develops the GABA-based investigational drug RemygenŽ as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and 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 CEOPhone: +46 736 35 42 41E-mail: [email protected]
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/diamyd-medical-ab/r/in-depth-analysis-showing-robust-diamyd--treatment-effects-across-clinical-trials-to-be-shared-at-th,c4061936
The following files are available for download:
https://mb.cision.com/Main/6746/4061936/3096442.pdf
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SOURCE Diamyd Medical AB
