STOCKHOLM, November 28, 2022 /PRNewswire/ — Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold of the DIAGNODE-3 confirmatory Phase III trial, evaluating the safety and efficacy of the medicine precision and antigen-specific immunotherapy Diamyd® in people recently diagnosed with type 1 diabetes. Following FDA decision, DIAGNODE-3 is cleared to start in the United States.
“This is an important milestone for Diamyd Medical and, more importantly, for patients with type 1 diabetes,” comments Ulf Hannelius, CEO of Diamyd Medical. “We look forward to moving forward with DIAGNODE-3 in the United States and will work diligently with researchers and patient groups to ensure that our treatment can be made available to patients with type 1 diabetes. in need.
The FDA has issued a partial clinical suspension of the pivotal DIAGNODE-3 trial in September 2021, suspending the start of the trial in the United States. Several interactions have taken place with the FDA since then to resolve the issues raised by the agency. Diamyd Medical will immediately resume the process of interacting with clinical sites and institutional review boards with the goal of including US clinical sites in the trial. DIAGNODE-3 is approved and actively recruiting patients in eight European countries.
The DIAGNODE-3 phase III trial, with Diamyd specific antigen immunotherapy®, will recruit approximately 330 people aged 12 to 28, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb DIAGNODE-1 and DIAGNODE-2 trials, as well as the large-scale meta-analysis encompassing data from more than 600 people from previous phases II and IIb. Phase III trials using Diamyd®. Additional stratification for HLA haplotypes will be included to assess the potential super-responder pool of individuals who are HLA DR3-DQ2 positive and HLA DR4-DQ8 negative.
The phase III trial will be conducted at more than 50 clinical sites. After a run-in period where all subjects receive vitamin D for one month, subjects will be randomized 2:1 to receive three intralymphatic injections of Diamyd® or a matching placebo administered one month apart, with a primary efficacy readout at 24 months from baseline. The design provides, based on efficacy data from previous trials in the HLA-restricted patient population, a high probability of achieving its primary endpoints: 1) preservation of endogenous insulin-producing capacity measured as boosted C-peptide, and 2) improved blood sugar control measured as HbA1c. The trial sponsor is Diamyd Medical.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory phase III trial, is actively recruiting patients with new-onset type 1 diabetes in eight European countries. Significant results have already been demonstrated in a large group of genetically predefined patients in a large-scale meta-analysis as well as in the Company’s DIAGNODE-2 European Phase IIb trial, where Diamyd® was administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A manufacturing plant is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in Diamyd antigen-specific immunotherapy®. Diamyd Medical is also developing Remygen, an investigational drug based on GABA® as a therapy for the regeneration of endogenous insulin production and to improve the hormonal response to hypoglycaemia. A Remygen initiated by the investigators® trial in people who have had type 1 diabetes for more than five years is underway at Uppsala University Hospital. Diamyd Medical is a major shareholder in stem cell company NextCell Pharma AB as well as artificial intelligence company MainlyAI AB.
Diamyd Medical’s B stock trades on the Nasdaq First North Growth Market under the symbol DMYD B. FNCA Sweden AB is the company’s licensed adviser.
For more information, please contact:
Ulf HanneliusPresident and CEO
Telephone: +46 736 35 42 41
E-mail: [email protected]
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SOURCE Diamyd Medical AB