Diamyd Diabetes Vaccine Study gets Green Light to Resume by the FDA

Diamyd Medical is a well-known biotech company based in Sweden that is working to develop an antigen-specific immunotherapy called Diamyd for type 1 diabetes. In September 2021, the US Food and Drug Administration (FDA) issued a partial US clinical hold on the phase III DIAGNODE-3 clinical trial of the drug. The FDA stated then that it did not have enough information on questions about the antigen-specific immunotherapy. Several interactions between the company and the regulatory agency have been held since then to resolve the FDA’s questions.

After over a year, on November 27 this year Diamyd Medical announced that the US FDA lifted the clinical hold on DIAGNODE-3, giving the company a green light to commence the trial in the US. Diamyd Medical stated they will immediately resume their process of interacting with institutional review boards and clinical sites with the goal of including US clinical sites in the trial.

“This is a significant milestone for Diamyd Medical and more importantly, for patients diagnosed with type 1 diabetes,” said Ulf Hannelius, CEO of Diamyd Medical, in the company’s press release. “We are looking forward to moving ahead with DIAGNODE-3 in the US and we will work diligently with investigators and patient groups to make sure that our therapy can be made available to type 1 diabetes patients in need.”

The trial DIAGNODE-3 is approved and currently recruiting patients in eight countries in Europe.

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The US Clinical Hold on the Diamyd Trial is Lifted, Now What?

Diamyd has already completed Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, respectively, for the antigen-specific immunotherapy Diamyd by recruiting more than 100 individuals with type 1 diabetes. After receiving the FDA’s nod, they look forward to enrolling around 330 individuals in DIAGNODE-3 who meet the following criteria:

• are between 12 and 28 years of age,
• were recently diagnosed with type 1 diabetes; and
• carry the HLA DR3-DQ2 haplotype.

A further stratification of HLA haplotypes will be done to evaluate the potential super responder group of participants who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.

This patient population is selected based on clinical safety and efficacy results from DIAGNODE-1 and DIAGNODE-2, as well as from a large-scale meta-analysis with data from over 600 participants from previous Phase II and Phase III trials of Diamyd.

DIAGNODE-3 is planned to be carried out in more than 50 clinical sites. All participants will receive vitamin D for one month, then participants will be randomized 2:1 to receive three intralymphatic injections of Diamyd or matching placebo given one month apart.

The primary endpoints of DIAGNODE-3 are:

• preservation of endogenous insulin producing capacity measured as stimulated C-peptide; and
• improved blood glucose control measured as HbA1c.

The primary efficacy readout for DIAGNODE-3 will be at 24 months from the baseline.