Diamyd Medical provides general update ahead of today’s Annual General Meeting
At today's Annual General Meeting, CEO Ulf Hannelius will present the latest updates with the precision medicine and antigen-specific immunotherapy Diamyd® as well as ongoing and upcoming developments at the Company’s manufacturing facility in Umeå in the north of Sweden. The meeting will be held at 3:00 pm CET in Stockholm.
Phase III trial is recruiting patients in Europe and is approved by FDA to start in the US
The confirmatory Phase III trial DIAGNODE-3, 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, Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia. Clinics at 43 sites have been organized with 34 currently recruiting study subjects. A total of approximately 50 clinics will be activated in Europe. Following the recent announcement by the the US Food and Drug Administration (FDA) that the trial in the US may start, Diamyd Medical has resumed the process of interacting with sites and institutional review boards for including also US sites in the trial.
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. Based on effiacy data from previous trials, this 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 after 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.
Diamyd Medical prepares for large-scale manufacturing of recombinant GAD protein and expands footprint in Umeå
Preparations are ongoing to initiate the manufacturing of the first technical batch of recombinant GAD protein early 2023, to be followed by additional technical and validation batches later in 2023. Diamyd Medical has also gained access to an additional 10,000 square feet of real estate connected to the current site to increase warehousing capacity for the biologics facility in Umeå. The expansion of Diamyd Medical’s activites in Umeå is deemed to provide important opportunities regarding warehousing, logistics and manufacturing capacity, including upcoming manufacturing milestones as the large-scale production will be tested and validated.
Diamyd Medical’s facility in Umeå Sweden totals approximately 20,000 square feet, encompassing clean rooms, lab space, offices and warehousing. The main purpose of the Umeå facility is to manufacture recombinant GAD protein to be used for upcoming trials and commercial production of the antigen-specific immunotherapy Diamyd®.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. Diamyd® is a tolerance-inducing and antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory Phase III trial is actively recruting patients 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 Diamyd® was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. A manufacturing 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: email@example.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was provided by the contact person above, for publication on
December 1, 2022, 12.15 CET.