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.

About Diamyd Medical

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.

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

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-aligns-with-fda-on-key-elements-for-an-accelerated-approval-process,c4081985

The following files are available for download:

View original content:https://www.prnewswire.co.uk/news-releases/diamyd-medical-aligns-with-fda-on-key-elements-for-an-accelerated-approval-process-302331214.html