Latent Autoimmune Diabetes in Adults

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 and 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 (). 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 CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB

STOCKHOLM, July 7, 2022 /PRNewswire/ -- The primary endpoints of safety and tolerability were met in the open-label investigator-initiated Phase II clinical trial GADinLADA, in which the diabetes vaccine Diamyd® was administered directly into the lymph node of 14 patients aged 30 to 70 years with the autoimmune form of diabetes called LADA (Latent Autoimmune Diabetes in Adults). Analyses also showed a positive immunological response to the treatment and the clinical course appears promising with all individuals remaining insulin-independent 12 months after treatment. "These results are very encouraging and the next step is together with collaborators and authorities evaluate the regulatory requirements to get the diabetes vaccine Diamyd approved as a disease-modifying therapy in individuals diagnosed with LADA", says Ulf Hannelius, CEO of Diamyd Medical. All patients in the trial were followed for twelve months after their first injection. The topline results showed that the safety was good with no treatment-related severe adverse events. The treatment was well tolerated by the trial participants, all of whom completed the study with no drop-outs. The immunological analyses showed a similar response to the treatment as has been shown in previous trials in individuals with recent-onset type 1 diabetes, with a clear GAD-specific immune response evident in both circulating antibodies and cell-based reactions. The clinical course appears positive with all 14 individuals remaining insulin-independent after 12 months of follow-up. The endogenous insulin production, measured as mixed-meal stimulated C-peptide, declined on average only 10% over 12 months. "The GADinLADA trial has been successful, and treatment with three intralymphatic injections of Diamyd has been well received by the LADA patients," says PhD Ingrid K Hals, Sponsor's representative of the trial. "We will present the results from this trial at the upcoming international Europen Association for the Study of Diabetes (EASD) conference in Stockholm in September and we look forward to evaluating together with Diamyd Medical the next steps to make this important treatment available for individuals diagnosed with LADA." Of the 14 LADA patients included in the trial, half carry the HLA haplotype DR3-DQ2 that is associated with a positive clinical response to Diamyd® treatment in individuals recently diagnosed with type 1 diabetes. For the 7 individuals carrying HLA DR3-DQ2, endogenous insulin production (stimulated C-peptide) decreased on average by 8 % over the 12 month study period, while in the 7 individuals not carrying HLA DR3-DQ2, it declined by 13 %. GAD-stimulated cell proliferation showed a decrease in proliferation between 5 and 12 months for the HLA-DR3-DQ2 group while a comparable decrease was not observed for the group negative for HLA DR3-DQ2, reflecting the patterns seen in recent-onset type 1 diabetes. The results will be presented at the upcoming EASD conference to be held in Stockholm on September 19-23, 2022. The accepted abstract is entitled "Early effects of treatment with intralymphatic administration of rhGAD65 in LADA appear similar to those observed in type 1 diabetes", and will be presented as an oral abstract on September 20, 2022, as part of the session "OP 10 Beta cells: protecting what is precious". 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 and were not yet on insulin therapy. 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; phone: +46 8-528 00 399, e-mail: [email protected] For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB