Patient recruitment for the pivotal Diamyd® Phase 3 trial is progressing according to plan
Diamyd Medical today announced that patient recruitment for the single pivotal precision medicine Phase 3 trial DIAGNODE-3 is progressing according to plan. Patient recruitment is ongoing in eight European countries and is being prepared to start in the US this summer. The trial is expected to be fully enrolled during the summer of 2024.
“We are very pleased to see that we are on target regarding our recruitment goals in this first of its kind precision medicine Phase 3 trial in type 1 diabetes”, says Ulf Hannelius, CEO of Diamyd Medical. “Patient recruitment is a crucial success factor for any clinical trial, and especially so given the challenges of the current world situation. We are very thankful to all participating clinics, patients and collaborators for their strong belief in the antigen-specific immunotherapy Diamyd and their dedication to move the therapeutic field of type 1 diabetes forward”.
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 eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia. A total of approximately 50 clinics will be activated in Europe and up to 10 sites in the United States.
DIAGNODE-3 will enroll approximately 330 individuals aged 12 to 29 years, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8.
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 to reach 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.
The primary efficacy readout is at 24 months from baseline. Currently, the trial includes a blinded interim analysis for sample size re-estimation purposes. The analysis will be conducted when 100-150 patients have been followed for 6 months. Diamyd Medical is continuously evaluating the optimal pathway forward for the antigen-specific immunotherapy Diamyd® that could provide important feedback to optimize clinical, regulatory and commercial activities including a potential interim analysis focusing on the treatment effect on stimulated C-peptide.
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 recruting pateients with recent-onset Type 1 Diabetes in eight European countries. 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 European Phase IIb trial DIAGNODE-2, where the Diamyd® was administered directly into a lymph node in children and young adults with recently diagnosed Type 1 Diabetes. A biomanufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen® trial in individuals living with Type 1 Diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as 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.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: firstname.lastname@example.org Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was provided by the contact person above, for publication on February 20, 2023, 14.00 CET.