Salute e Benessere
Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process
The early readout, planned for March 2026 for the ongoing Phase 3 DIAGNODE-3 trial, will include approximately 170 evaluable participants who have completed their 15-month assessment. As of today, 191 patients have been randomized in the trial. This analysis will provide efficacy data based on preservation of C-peptide levels, which the FDA, following a Type C meeting held in July 2024 with Diamyd Medical, recognizes as a surrogate endpoint reasonably likely to predict clinical benefit in Type 1 Diabetes, and can therefore be used to obtain Accelerated approval.
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III 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 IIb trial, where Diamyd 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 Diamyd . Diamyd Medical also develops the GABA-based investigational drug Remygen 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.
Ulf Hannelius , President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
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