Immunotherapy to treat people with type 1 diabetes genotype granted fast track designation
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Key takeaways:
- Fast track designation has been granted to an antigen-specific immunotherapy for young people with type 1 diabetes.
- The immunotherapy will be invested in the phase 3 DIAGNODE-3 trial.
The FDA granted fast track designation for an immunotherapy to treat type 1 diabetes among people with the human leukocyte antigen DR3-DQ2 genotype, according to a press release.
The antigen-specific immunotherapy is a recombinant human glutamic acid decarboxylase formulated with aluminum hydroxide (Diamyd, Diamyd Medical). The phase 3 DIAGNODE-3 trial is assessing safety and efficacy of the therapy among adolescents and young adults aged 12 to 29 years who carry the human leukocyte antigen (HLA) DR3-DQ2 genotype, a genetic risk factor for type 1 diabetes. Participants must have been diagnosed with type 1 diabetes within 6 months of trial enrollment. The trial will include up to 330 participants and will further stratify the study group for HLA haplotypes to evaluate for a potential super-responder group who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.
In previous clinical trials, the immunotherapy demonstrated the potential to modulate the immune system’s response against pancreatic beta cells to halt or slow the progression of type 1 diabetes, according to the press release. The patient populations for DIAGNODE-3 is based on efficacy and safety results from the phase 2a DIAGNODE-1 and phase 2b DIAGNOSE-2 trials as well as a large-scale meta-analysis that includes data from more than 600 people who used the therapy in prior phase 2 and phase 3 trials. The co-primary endpoints of DIAGNODE-3 will be preservation of endogenous insulin producing capacity as measured through stimulated C-peptide and improved glycemic control as assessed by HbA1c.
“We are very pleased with the FDA's decision to grant fast track designation for Diamyd and the potential this provides to accelerate Diamyd’s path to entering the U.S. market,” Ulf Hannelius, CEO of Diamyd Medical, said in the release. “Type 1 diabetes is a progressive, chronic and irreversible autoimmune disease that affects millions of patients worldwide. Diamyd ... represents a significant shift towards personalized medicine in the treatment of type 1 diabetes. This offers new hope beyond the traditional insulin therapy, emphasizing our dedication to advancing care and improving outcomes for patients.”
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