Interim report for Diamyd® directly into the lymph node for patients with LADA
An initial interim report from the open-label investigator-initiated clinical trial GADinLADA, in which the diabetes vaccine Diamyd® is administered directly into the lymph node in 14 patients aged 30 to 70 years with the autoimmune form of diabetes called LADA (Latent Autoimmune Diabetes in Adults), shows that treatment after five months is safe and tolerable. Preliminary analyses indicate that the immunological response to the treatment is similar to what has been observed in individuals with type 1 diabetes treated with Diamyd®.
“It is of course important that we can state that the safety of intralymphatic Diamyd® treatment looks very good also in these individuals in a higher age group; in the LADA trial patients up to the age of 70 are treated” says Ulf Hannelius, CEO of Diamyd Medical. “It is also positive and interesting that the immunological response to the treatment seems to be consistent with what we have seen in our trials with type 1 diabetes patients”.
All patients have been followed for five months after their first injection. The interim report indicates that the safety is good and no severe adverse events have been reported in the trial. The immunological analyses show that the treatment induces a clear GAD-specific immune response both in term of antibodies and cell-based reactions.
In the 14 LADA patients included in the trial, all having received intralyphatic Diamyd®, it was found that half carry the HLA haplotype DR3-DQ2, ie the haplotype that has been shown to be associated with a positive clinical response to Diamyd® treatment in individuals with type 1 diabetes.
“It will be interesting at the 12-month analysis in Q3 2022 to see if the differences in immune response between the HLA subgroups can be observed even in this smaller group of LADA patients,” Ulf Hannelius continues.
The patiens will be followed for a total of 12 months from the first injection, which means that end results, including the clinical follow-up on C-peptide and blood glucose control from the trial, are expected to be presented during the third quarter of 2022.
“The trial has so far been successful and treatment with intralymphatic injections of Diamyd has been well received by the LADA patients,“ says PhD Ingrid K Hals, Sponsor’s representative of the trial. “This gives us a solid basis for the continued work with the trial toward the final summary of the trial results during the second half of 2022.”
About the GADinLADA trial
The main aim of the trial is to evaluate the safety of intralymphatic treatment with Diamyd® in patients with LADA (Latent Autoimmune Diabetes in Adults). The patients have been recruited in Norway at the Norwegian University of Science and Technology (NTNU) in Trondheim, in collaboration with St. Olavs Hospital, University Hospital in Trondheim, and in Sweden at the Center for Diabetes, Akademiskt specialistcentrum, an academic specialist unit run in collaboration between Stockholm County's healthcare area, Karolinska Institutet and Karolinska University Hospital. The patients included in the trial are between 30 and 70 years old, have been diagnosed with LADA within the last 18 months and are not yet on insulin therapy. The Sponsor of the trial is the Norwegian University of Science and Technology with Ingrid K Hals as Sponsor's representative. Diamyd Medical contributes with study drugs, expertise and some financial support for immunological analyzes and determination of HLA haplotypes. For more information about the GADinLADA trial, please visit www.GADinLADA.com
About LADA
Latent Autoimmune Diabetes in Adults represents close to 10% of patients diagnosed with type 2 diabetes. LADA is characterized by an ongoing autoimmune destruction of the insulin-producing beta cells, a process similar to that of type 1 diabetes, but slower. Although research categorizes LADA as autoimmune diabetes, the disease is still in most cases treated according to the guidelines for type 2 diabetes. LADA patients are usually not insulin dependent at diagnosis, but for most patients, insulin therapy is required within a few years of diagnosis.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have 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 diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. Preparations for a confirmatory Phase III trial are on-going. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine 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; phone: +46 8-528 00 399, e-mail: info@fnca.se
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
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: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided by the contact person above, for publication on December 7, 2021, 11.45 CET.
Tags: