DIAGNODE-3 Trial Enrolls 100th Patient

Diamyd Medical, a company specializing in precision medicine therapies, has achieved a significant milestone in its Phase 3 clinical trial for Type 1 Diabetes, known as DIAGNODE-3. The trial has successfully enrolled its 100th patient, and notably, there have been no serious adverse events or patient withdrawals reported thus far.

Ulf Hannelius, the President and CEO of Diamyd Medical, expressed his satisfaction with the milestone, highlighting the zero dropout rate as a testament to the safety and convenience of the Diamyd® treatment. He extended his gratitude to the participants and the staff at the participating clinics for their dedication to the trial.

The DIAGNODE-3 trial is a pioneering effort in precision medicine for Type 1 Diabetes, being conducted across eight European nations and the United States. It specifically targets patients with the genetic HLA DR3-DQ2 haplotype, which has shown a positive response to Diamyd® treatment in earlier trials. The U.S. FDA has recognized the potential of Diamyd® by granting it both Orphan Drug and Fast Track designations.

The trial aims to enroll a total of 330 individuals, aged between 12 to 29 years, who have been recently diagnosed with Type 1 Diabetes and carry the HLA DR3-DQ2 genetic risk factor. The trial also includes an additional stratification to identify a group of patients who may respond exceptionally well to the treatment. The patient selection is based on previous clinical trials and a comprehensive meta-analysis involving data from over 600 individuals.

The design of DIAGNODE-3 is crafted to achieve its dual primary objectives: to preserve the body's insulin production capacity, as indicated by stimulated C-peptide levels, and to enhance blood glucose control, as measured by HbA1c levels. The trial is partially funded by JDRF, a leading global organization advocating for Type 1 Diabetes research.

Diamyd Medical's flagship product, Diamyd®, is an antigen-specific immunomodulatory therapeutic designed to preserve the body's insulin production. It has shown promising results in a genetically specific patient group, as evidenced by a large-scale meta-analysis and a European Phase IIb trial. The treatment involves injections into a superficial lymph node, a procedure that is quick and aims to optimize the immune response. To support the production of Diamyd®, a biomanufacturing facility is being developed in Umeå, Sweden, to manufacture the recombinant GAD65 protein, which is the active ingredient in Diamyd®.

In addition to Diamyd®, Diamyd Medical is also developing Remygen®, a GABA-based investigational drug for metabolic diseases. The company holds significant stakes in NextCell Pharma AB, a stem cell company, and MainlyAI AB, an artificial intelligence firm. Diamyd Medical's B-shares are publicly traded on the Nasdaq First North Growth Market under the ticker DMYD B, with FNCA Sweden AB serving as the company's Certified Adviser.