On June 22, 2022 Diamyd Medical reported it’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B (Press release, Diamyd Medical, JUN 22, 2022, View Source/docs/pressClip.aspx?section=investor&" target="_blank" title="View Source/docs/pressClip.aspx?section=investor&" rel="nofollow">View Source;ClipID=4295146 [SID1234616159]).
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September 1, 2021 – May 31, 2022
Net result: MSEK -63.4 (87.3), third quarter: MSEK -17.1 (-32.7). The previous year includes a one-off effect of corresponding MSEK 144.4 from divestment of shares in Companion Medical, Inc.
Result per share: SEK -0.8 (1.3), third quarter: SEK –0.2 (-0.5)
Cash flow from operating activities: MSEK -50.7 (-50.4), third quarter: MSEK -35.7 (-21.4)
Cash and cash equivalents at May 31, 2022: MSEK 192.8 (194.2)
Other events during the third quarter
Analysis of prevention trial with Diamyd published in Journal of Immunology Research
First patient enrolled in the Phase III trial DIAGNODE-3
Principal owner transferred half of his holdings in Diamyd Medical to his children
New meta-analysis with Diamyd published in Diabetes, Obesity and Metabolism
Diabetes prevention project coordinated by Diamyd Medical presented at scientific conference
Investigator-initiated clinical trial to evaluate booster injection with Diamyd started
Other events after the third quarter
Analysis supporting treatment with Diamyd published in The Journal of Clinical Endocrinology & Metabolism
Comments by CEO Ulf Hannelius
In May we reported a significant milestone as the first patient was randomized in the precision medicine trial DIAGNODE-3 with Diamyd. Approximately 20 clinics in Europe have so far been initiated and additional clinics and countries in Europe are underway.
In parallel, we are working diligently with the FDA with the aim to offer this important trial also to clinics and patients in the United States. As we aim to recruit the approximately 330 individuals with recent onset Type 1 Diabetes carrying the genetic HLA DR3-DQ2 haplotype for DIAGNODE-3 over the course of two years, there should be time to work with the FDA to resolve any outstanding questions, however we do have readiness to perform the trial solely in Europe if required to keep recruitment timelines.
A "Booster trial" with Diamyd, DIAGNODE-B, has started where approximately six individuals who have previously been treated with intralymphatic Diamyd and carry the responder haplotype HLA DR3-DQ2, will receive an additional booster injection. The Sponsor is Linköping University, and results will build on our existing insights into boosters and give knowledge about how effect of Diamyd is possibly further improved and/or prolonged as is often the case with vaccines.
The scientific rational and evidence supporting our therapeutic diabetes vaccine Diamyd was further strengthened the past quarter with three articles published in peer-reviewed scientific journals. These publications highlight three important findings:
As published in Diabetes, Obesity and Metabolism, a largescale meta-analysis showed how the therapeutic effect of Diamyd on endogenous insulin production measured as C-peptide associates with improved blood glucose measured as HbA1c. This is to our knowledge the first time this association has been shown for a disease modifying therapy in Type 1 Diabetes and importantly supports the current regulatory requirements regarding clinical efficacy in pivotal trials.
As published in Journal of Clinical Endocrinology & Metabolism, results based on continuous glucose monitoring showed how treatment with Diamyd increases time in optimal glucose range, decreases time in hyperglycemia and decreases glycemic variability. These are important patient centric measures highlighted in several talks during the 82nd Scientific Sessions organized held earlier this month in New Orleans and organized by the American Diabetes Association earlier this month.
As published in the Journal of Immunology Research, treatment with Diamyd in healthy children at risk for Type 1 Diabetes leads to a decrease in T-lymphocyte counts compared to placebo. This is the first report of the immune response following Diamyd treatment in this population and supports our efforts as part of the ASSET project (www.asset.healthcare) to predict and prevent Type 1 Diabetes.
ASSET, an innovation milieu focusing on risk prediction, prevention, and national screening of Type 1 Diabetes, coordinated by Diamyd Medical and supported by the Swedish Innovation Agency VINNOVA, was also presented at the Scandinavian Society for the Study of Diabetes meeting in Reykjavik last month. With ASSET financing we look forward to starting the first ever "prevention trial" in individuals carrying at least two beta cell autoantibodies and the HLA DR3-DQ2 haplotype, in order to save these individuals from becoming insulin requiring (Stage-3 Type-1 Diabetes). We expect to announce the 12-month results from the GADinLADA trial lead by Norwegian University of Science and Technology late summer/early autumn. Our collaborators in Norway will present results at the upcoming international EASD conference in Stockholm in September this year, highlighting the importance of intervention in LADA.
We are proud to be strong both regarding our cash position as well about our ongoing value creating activities including the pivotal Diamyd program; the vaccine manufacturing facility in Umeå; our second diabetes clinical asset Remygen, and our investments in artificial intelligence and stem cells.
All this gives us strength to advance our mission to fundamentally change the therapeutic landscape of Type 1 Diabetes.
Stockholm, June 22, 2022
Ulf Hannelius, President and CEO
Other events during the third quarter
March 1, 2022 – May 31, 2022
Immunological analysis of prevention trial with Diamyd was published in peer-reviewed scientific journal
Results of an analysis of a previous prevention trial with Diamyd (GAD-alum) treatment, which indicate a positive and sustained immunomodulating effect after treatment with Diamyd in healthy children at risk for Type 1 Diabetes, have been published in Journal of Immunology Research.
The first patient was enrolled in Diamyd Medical’s Phase III trial DIAGNODE-3
The first patient received its first intralymphatic injection of Diamyd in the precision medicine Phase III trial DIAGNODE-3. The trial will include approximately 330 patients aged 12 to 29 years newly diagnosed with Type 1 Diabetes who carry the genetically defined haplotype HLA DR3-DQ2.
Diamyd Medical’s principal owner transferred half of his holdings in Diamyd Medical to his children
Anders Essen-Möller notified the Swedish Financial Supervisory Authority of the sale of 4,500,000 Diamyd Medical shares in the form of gifts. Essen-Möller’s five children each received 400,000 Class A shares and 500,000 Class B shares.
New meta-analysis with Diamyd was published in peer-reviewed scientific journal
An update of a large-scale meta-analysis supporting the efficacy of the therapeutic diabetes vaccine Diamyd in individuals recently diagnosed with Type 1 Diabetes carrying the genetic HLA DR3-DQ2 haplotype was published in the peer-reviewed scientific journal Diabetes, Obesity and Metabolism. The analysis shows that treatment effect with Diamyd on the preservation of endogenous insulin production measured as C-peptide is associated with a beneficial treatment effect on blood glucose measured as HbA1c.
Diabetes prevention project coordinated by Diamyd Medical was presented at a scientific conference
The ASSET (AI for Sustainable Prevention of Autoimmunity in the Society) innovation milieu for the development of improved prevention strategies in Type 1 Diabetes, funded by the Swedish innovation agency VINNOVA was presented by CEO Ulf Hannelius at the Annual Meeting of the Scandinavian Society for the Study of Diabetes (SSSD), in Reykjavík in May.
New clinical trial will evaluate an additional injection (booster) with Diamyd
A new investigator-initiated clinical trial, DIAGNODE-B, started. The trial will evaluate the safety, impact on the immune system and the clinical efficacy of an additional injection with the antigen-specific immunotherapy Diamyd. The trial has been approved by the Swedish Medical Products Agency and the Ethical Review Authority and will be offered to approximately 6 patients from the previous trials DIAGNODE-1 and DIAGNODE-2.
Other events after the third quarter
Analysis supporting treatment with Diamyd published in peer-reviewed scientific journal
An article presenting analyses of Continuous Glucose Monitoring (CGM) data from the randomized, placebo-controlled Phase 2b trial DIAGNODE-2 that assessed three intralymphatic injections of the therapeutic diabetes vaccine Diamyd, has been published in the peer-reviewed scientific journal The Journal of Clinical Endocrinology & Metabolism (JCEM).
Two drugs in clinical development
Diamyd and Remygen are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.
Diamyd is an antigen-specific immunomodulating precision medicine diabetes vaccine for the treatment and prevention of autoimmune diabetes (type 1 diabetes and LADA, Latent Autoimmune Diabetes in Adults).
Clinical data indicate the potential of the diabetes vaccine Diamyd to halt or stop the autoimmune destruction of insulin-producing beta cells in individuals that carry the HLA DR3-DQ2 haplotype. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd in superficial lymph nodes. By maintaining the endogenous insulin production, Diamyd has the potential to make a significant difference in the daily life of patients as well significantly reduce the complications of type 1 diabetes. Topline results from the Phase IIb trial DIAGNODE-2 demonstrated a significant treatment effect of Diamyd in the predefined genetic patient group. A confirming Phase III trial, DIAGNODE-3, is on-going.
Remygen is an oral regenerative and immunomodulatory drug candidate for the treatment of autoimmune- and type 2 diabetes. By stimulating the growth of insulin-producing cells, Remygen has the potential to reverse the disease progression in autoimmune- and type 2 diabetes. Based on clinical data, Remygen has also the potential to protect against hypoglycemia by improving the hormonal response. Remygen is now being investigated in a clinical Phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing the treatment regimen ahead of registration-based trials.
Clinical trials
Type 1 Diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd, an antigen-specific precision medicine immunotherapy aimed at stopping the immune system’s attack on insulin-producing beta cells in autoimmune diabetes, are evaluated in the Phase III trial DIAGNODE-3, in the Phase II trial GADinLADA and in the Phase I/II trial DIAGNODE-B.
Remygen, which aims to stimulate the growth of beta cells in patients with diabetes, is evaluated in patients in the Phase I/II trial ReGenerate-1.
Ongoing clinical trials
Trials with Diamyd in lymph node
DIAGNODE-3 – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
The placebo-controlled Phase III trial DIAGNODE-3 will include approximately 330 individuals aged 12 to 28 who have been recently diagnosed with type 1 diabetes and who carry the genetically defined haplotype HLA DR3-DQ2. The trial will be conducted at approximately 50 clinics, where almost half of all individuals with Type 1 Diabetes are estimated to carry the current haplotype. After an initial month in which all trial participants receive vitamin D, the individuals will be randomized 2:1, ie two out of three trial participants will receive three intralymphatic injections of Diamyd and one in three will receive the corresponding placebo at one month intervals, with one primary reading 24 months after trial start. The design provides, based on efficacy data from previous studies on the HLA-restricted patient population, a high probability of reaching the primary endpoints; preservation of stimulated C-peptide and lower HbA1c. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University. The Sponsor of the trial is Diamyd Medical.
GADinLADA – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN-D
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 NTNU 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. 12-month results are expected later in 2022.
DIAGNODE-B – ADDITIONAL INJECTION OF DIAMYD IN LYMPH NODES
The aim of the trial is to evaluate the safety of a booster (fourth/fifth) injection with Diamyd and the effect on the immune system and the endogenous insulin production. DIANGODE-B is an open-label investigator-initiated clinical trial enrolling Type 1 Diabetes patients who carry the genetically defined haplotype HLA DR3-DQ2 and are previously treated with intralymphatic injections of Diamyd. The trial is planned to include approximately 6 patients who have either been treated with four injections in DIAGNODE-1, who will then receive a 5th intralymphatic injection of Diamyd, or patients who participated in DIAGNODE-2, who will receive a 4th intralymphatic injection of Diamyd, approximately 4 years after the last injection. The patients will be followed for 12 months after injection. The trial is conducted at the Clinical Research Unit at the University Hospital in Linköping. Sponsor of the trial is Linköping University with Professor Johnny Ludvigsson as Sponsor’s representative.
Trial with Remygen (GABA)
REGENERATE-1 – REMYGEN /ALPRAZOLAM
An open-label, investigator initiated clinical trial with Remygen. The trial includes 35 patients aged 18-50 who have had Type 1 Diabetes for more than five years with low to non-existing insulin production. Safety and initial efficacy results from the dose escalation section of the trial have paved the way to initiate the main trial and have also demonstrated a potential effect of Remygen to improve the hormonal response to hypoglycemia. The main trial evaluates whether the insulin-producing cells can be regenerated and if the hormonal response to hypoglycaemia can be improved using Remygen and the combination of Remygen and Alprazolam. The trial is led by Professor Per-Ola Carlsson at Uppsala University, Sponsor of the trial.
Results are expected in the first quarter of 2023.
Manufacturing of GAD65 in Umeå
A new facility for vaccine manufacturing is being set up in Umeå, the Capital of Västerbotten County in Sweden, for the manufacture of recombinant GAD65, the active pharmaceutical ingredient in the therapeutic diabetes vaccine Diamyd currently in late-stage clinical development. The 10 000 square feet site, comprising of clean rooms, laboratory facilities and office space, will facilitate full control, predictability and scalability of the manufacturing technology of the active ingredient. Diamyd Medical has chosen Cytiva’s configurable single-use bioprocess manufacturing platform FlexFactory for the process. Small-scale experimental production of GAD65 is now established at the manufacturing facility. Large-scale production is being set up primarily using Cytiva equipment. The property where the manufacturing is being established is owned by Diamyd Medical.