NEW YORK – Diamyd Medical on Monday said it will seek accelerated approval in the US for its eponymous antigen-specific immunotherapy as a treatment for a genomically defined population of patients with stage 3, type 1 diabetes.
The Stockholm-based company has designed Diamyd (rhGAD65/alum), which is injected into a superficial lymph node, to preserve endogenous insulin production. Diamyd Medical said it will file interim data from a Phase III trial, dubbed DIAGNODE-3, in its biologics license application (BLA) to the US Food and Drug Administration.
So far, Diamyd Medical has randomized 148 out of 330 stage 3 type 1 diabetes patients it plans to enroll into the study, which is underway in eight European countries and in the US. To partake in the trial, patients must have the HLA DR3-DQ2 genotype, which occurs in 40 percent of stage 3 type 1 diabetes cases. This subgroup has responded well to the immunotherapy in prior trials, according to Diamyd Medical.
In its planned BLA, Diamyd Medical will submit efficacy data on the immunotherapy from approximately 170 stage 3 type 1 diabetes patients who have completed their 15-month assessment and file safety data from additional DIAGNODE-3 trial participants. For the primary endpoint of the study, researchers are examining how the investigational treatment impacts C-peptide levels, a measure of endogenous insulin production and a surrogate endpoint that the FDA has said could be reasonably likely to predict clinical benefit.
Diamyd Medical expects the interim data from the trial to read out in March 2026. After that, the firm will continue to follow patients for two years.
The immunotherapy has orphan drug and fast-track designations from the FDA as an investigational treatment for stage 1, 2, and 3 type 1 diabetes.