Salute e Benessere
Diamyd Medical Announces Positive Interim Analysis Results for Phase 3 Trial in Type 1 Diabetes
The interim analysis evaluated six-month data from 74 patients enrolled in the trial, assessing the likelihood of the trial achieving one of its co-primary endpoints, specifically the preservation of endogenous insulin-producing capacity measured as stimulated C-peptide. The DSMB's recommendation is based on the data observed to date, indicating that the trial is on track and has the potential to meet its objectives.
The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com), evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd in individuals diagnosed with Type 1 Diabetes is ongoing in
the United States and in eight European countries:
Sweden , Spain , the
Czech Republic , the Netherlands ,
Germany , Poland ,
Hungary and Estonia .
DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within six months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for this disease. A further stratification for HLA haplotypes is included to evaluate a potential superresponder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. HLA testing is well-established and widely available to identify such individuals, through a precision based medicine approach.
This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd . The trial design provides a high probability of reaching its co-primary endpoints of preservation of endogenous insulin-producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c.
As previously announced, Diamyd Medical is evaluating the potential of an earlier readout in the DIAGNODE-3 trial. This is based on the FDA acknowledging that C-peptide could be used by Diamyd Medical as a surrogate endpoint that is reasonably likely to predict the clinical benefit of preservation of endogenous insulin production. As such, Accelerated Approval could be sought based on demonstrating significant treatment-related benefits on C-peptide levels in response to Diamyd administration.
DIAGNODE-3 is supported, in part, by funding from Breakthrough T1D (formerly JDRF), the leading global Type 1 Diabetes research and advocacy organization.
Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå,
Sweden , for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd . Diamyd Medical also develops the GABA-based investigational drug Remygen as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.
Ulf Hannelius , President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
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