Publicado 20/09/2022 15:30

Updated results from clinical trial with Diamyd® presented today at diabetes conference

STOCKHOLM, Sept. 20, 2022 /PRNewswire/ -- Updated 12-month results from the open-label investigator-initated Phase II clinical trial GADinLADA that assessed three intralymphatic injections of the therapeutic diabetes vaccine Diamyd® in individuals diagnosed with Latent Autoimmune Diabetes in Adults (LADA) were presented today at the European Association for the Study of Diabetes (EASD) conference in Stockholm, Sweden. The updated results provide further support to the previously reported topline results that showed a positive immunological nd metabolic response to Diamyd® treatment in individuals diagnosed LADA who carries the genetic HLA DR3-DQ2 haplotype.

Topline results announced on August 5, 2022

As previously communicated in press releases on July 7 and August 5, 2022, the primary endpoints of safety and tolerability after 12 months were met in the open-label investigator-initiated Phase II clinical trial GADinLADA, in which the therapeutic diabetes vaccine Diamyd® was administered intralymphatically to 14 patients aged 30 to 70 years old with the autoimmune form of diabetes LADA. All individuals remained insulin-independent 12 months after treatment with no treatment-related severe adverse events or drop-outs. For the 7 individuals carrying HLA DR3-DQ2, endogenous insulin production measured as mixed-meal stimulated C-peptide decreased on average by 5 percentage points less during the 12-month study period compared to the 7 individuals not carrying HLA DR3-DQ2. Preliminary (5 months) data on safety and endogenous insulin production have been published in the scientific journal Frontiers in Endocrinology.

Updated 12-month results presented today at EASD

The updated results provide additional support for a positive immunological and metabolic response in LADA patients with HLA DR3-DQ2. Glycated hemoglobin HbA1c, a measure of blood glucose, increased slightly during the trial in most patients. While no significant differences were observed between the groups, average values of HbA1c at baseline, 5 months, and 12 months were lower in patients with HLA DR3-DQ2 compared to the patients lacking HLA DR3-DQ2. Median glucagon-stimulated C-peptide levels, an alternative measure of endogenous insulin production, were unchanged at 12 months compared to baseline in the HLA DR3-DQ2 positive patients, indicating complete preservation of insulin producing capacity. In patients lacking HLA DR3-DQ2 the glucagon-stimulated C-peptide levels declined by 13%.

"These results are intriguing and while we cannot make defintive conclusions regarding efficacy, the response does appear quite positive compared to what we know about the disease progression in individuals diagnosed with LADA who display strong signs of autoimmunity", says PhD Ingrid K Hals, Sponsor's representative of the trial.

The oral presentation by PhD Ingrid K Hals was entitled "Effects of treatment with intralymphatic administration of rhGAD65 in LADA appear similar to those observed in type 1 diabetes" and was held on September 20, 2022, as part of the session "OP 10 Beta cells: protecting what is precious" at the EASD conference (https://www.easd.org/annual-meeting/easd-2022.html).

The complete 12-month results of the GADinLADA trial will be submitted for publication in a peer-reviewed scientific journal later this year.

Diamyd Medical is represented with its own booth in the Exhibitor Hall at the EASD conference which is held this week in Stockholm, September 19-23, to promote the ongoing confirmatory Phase III trial DIAGNODE-3 in recent-onset Type 1 diabetes patients positive for HLA DR3-DQ2.

About the GADinLADA trial

The main aim of the trial was to evaluate the safety of three intralymphatic injections of Diamyd® in patients with LADA (Latent Autoimmune Diabetes in Adults). The patients were recruited in Norway at the Norwegian University of Science and Technology (NTNU), Dept. of Clinical and Molecular Medicine, 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 were between 30 and 70 years old, diagnosed with LADA within the last 18 months, were not yet on insulin therapy and displayed strong signs of autoimmunity defined as high titers of GAD autoantibodies. The Sponsor of the trial has been the Norwegian University of Science and Technology with Ingrid K Hals, PhD, as Sponsor's representative. Diamyd Medical has contributed with study drugs, expertise and some financial support for immunological analyses and determination of HLA haplotypes.

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. DIAGNODE-3, a confirmatory Phase III trial is 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.

For further information, please contact:Ulf Hannelius, President and CEOPhone: +46 736 35 42 41E-mail: ulf.hannelius@diamyd.com

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