Tillkännagivande • May 11
Diamyd Medical AB (publ) Provides Update on Strategic Review and Clinical Development Plans Diamyd Medical AB (publ) announced that the initial phase of the strategic review, initiated following the discontinuation of the Phase 3 DIAGNODE-3 trial, has been completed. The initial review phase has resulted in the identification of a short list of potential counterparties, and the Company will now proceed with a focused evaluation of these. As part of the review, Diamyd Medical is also evaluating strategic alternatives for its biomanufacturing facility in Umeå including potential stand-alone opportunities, or a divestment. With respect to retogatein (rhGAD65), the Company does not intend to allocate further internal resources to future clinical development. Instead, efforts will be directed toward organizing, packaging, and preparing the relevant data, documentation, and know-how to enable a potential out-licensing, partnership, or transfer to an external party. Tillkännagivande • Apr 26
Diamyd Medical AB Announces Steps Down of Ulf Hannelius as CEO Diamyd Medical AB announced that CEO Ulf Hannelius has decided to step down from his role following unexpectedly negative results from the March 27, 2026 interim analysis of its DIAGNODE-3 study. Ulf Hannelius has during his now 10 years as CEO at Diamyd, made a formidable contribution to the Company's development, and in particular the achievement of receiving both Fast Track Designation and Accelerated Approval potential for retogatein in the US. The search process for a new CEO is being initiated. Tillkännagivande • Apr 25
Diamyd Medical AB Announces Appointment of Anders Essen-Möller as Executive Chairman, Effective April 22, 2026 Diamyd Medical AB announced that Anders Essen-Möller was appointed to the position as Executive Chairman as per April 22, 2026. Tillkännagivande • Apr 11
Diamyd Medical Discontinues Diagnode-3 And Initiates Strategic Review Diamyd Medical announced that it will discontinue the Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in Stage 3 type 1 diabetes. Following the previously reported interim analysis and subsequent evaluation of the interim results, including independent external statistical validation, the Company has concluded that the interim results meet the pre-specified futility criteria and do not support continuation. The interim analysis results, first announced on Friday March 27, were based on 174 evaluable participants followed from baseline to month 15. The results showed no clinically meaningful effect on C-peptide, a marker for endogenous insulin secretion, in the overall population or in pre-specified subgroups. In addition to this, the pre-specified criteria required to support continuation of the trial were not met. In an evaluation that included review of the data derivation, patient randomization, and statistical assumptions used for the interim analysis, no factors were identified that meaningfully affected the interpretation of the results. No new safety concerns have been identified. Available glycemic data, specifically HbA1c and Time in Range, are consistent with the C-peptide results and indicate a well-controlled patient population with no observable differences between the active and placebo arm at month 15. Diamyd Medical will initiate an orderly wind-down of the trial that prioritizes patient safety and meets all ethical and regulatory requirements. The Company will proceed with unblinding of the dataset and conduct a comprehensive analysis to better understand the outcome. The Company will assess the future potential and direction of its GAD-based immunotherapy program based on insights from this analysis. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial in patients with recent-onset (Stage 3) type 1 diabetes was discontinued following a pre-planned interim futility analysis which indicated that the study was unlikely to meet its primary endpoint. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40% of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Tillkännagivande • Mar 30
Diamyd Medical Updates on Interim Efficacy Analysis of Phase 3 DIAGNODE-3 Trial Diamyd Medical on March 27 announced that the pre-specified interim efficacy analysis on 174 out of 321 participants of the ongoing Phase 3 DIAGNODE-3 trial yielded results that were unexpected and not aligned with prior retrospective or prospective data. Based on the interim dataset, no treatment effect on C-peptide was observed, neither in the overall population nor in pre-specified subgroups, including the previously identified potential super responder group. The Company will conduct a comprehensive assessment of the analysis results that were received late on Friday March 27. The Company's core operations, including manufacturing activities, will continue as planned during this period. To ensure patient safety and full compliance with ethical and regulatory standards Diamyd Medical will engage with regulatory authorities to determine appropriate next steps. Diamyd Medical will report further findings as analyses progress and will continue to communicate transparently on conclusions and next steps. The Company will hold live conference calls March 30, 2026 . Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial in patients with recent-onset (Stage 3) type 1 diabetes was discontinued following a pre-planned interim futility analysis which indicated that the study was unlikely to meet its primary endpoint. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40% of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Tillkännagivande • Mar 28
Diamyd Medical Reports Negative Interim Results of Phase 3 DIAGNODE-3 Trial Diamyd Medical announced the completion of a pre-specified interim efficacy analysis on C-peptide in the ongoing pivotal Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals with recent-onset Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 haplotype. The interim analysis that included 174 out of 321 study participants did not demonstrate statistical significance on the primary endpoint at this timepoint. In addition to this, the pre-specified criteria required to support continuation of the trial were not met. No safety concerns were identified during the interim review. Diamyd Medical will provide an update with more information no later than 29 March 2026. Tillkännagivande • Mar 23
Diamyd Medical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 233.24681 million. Diamyd Medical AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 233.24681 million.
Security Name: Class B shares
Security Type: Common Stock
Securities Offered: 17,226,500
Price\Range: SEK 13.54 Tillkännagivande • Mar 20
Diamyd Medical Receives Notice Of Grant In Japan For Insulin-Based Antigen Therapy Patent In Type 1 Diabetes Diamyd Medical has received a Notice of Grant in Japan for a patent covering the use of insulin-based antigens to treat individuals with type 1 diabetes who carry the HLA DR4-DQ8 genetic marker. Once issued, the patent is expected to remain in force until 2038. Diamyd Medical holds granted precision medicine patents for treating and preventing type 1 diabetes in key global markets: The newly granted Japanese patent for insulin-based antigen therapy targeting individuals with HLA DR4-DQ8 has corresponding patents granted in Europe, Eurasia, Hong Kong, and South Korea, with additional applications pending in other territories. Patents covering the treatment and prevention of type 1 diabetes in individuals carrying HLA DR3-DQ2 using retogatein (rhGAD65) have been granted in Europe, Eurasia, Hong Kong, Israel, Japan, South Africa, and South Korea. These protections extend through 2038, with further applications under review in additional markets. Together, the HLA DR3-DQ2 and HLA DR4-DQ8 genetic markers are present in up to 90% of individuals with type 1 diabetes, highlighting the broad clinical relevance of these targeted therapies. Retogatein (rhGAD65) formulated with alum is an investigational antigen-specific immunotherapy, designed to induce antigen-specific immune tolerance to GAD65 and preserve endogenous insulin production in individuals with type 1 diabetes who carry the HLA DR3-DQ2 gene. Retogatein has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Fast Track Designation has also been granted for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US, is being conducted at 57 clinics in eight European countries and in the US in patients with recent-onset (Stage 3) type 1 diabetes. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial has only included patients from this specific patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40% of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of retogatein (recombinant GAD65 protein), the active ingredient in the antigen-specific immunotherapy. Tillkännagivande • Feb 24
Diamyd Medical Announces Finalization of Database for Interim Analysis in Phase 3 DIAGNODE-3 Trial The clinical database has been finalized for the pre-specified interim efficacy analysis in Diamyd Medical's ongoing pivotal Phase 3 trial (DIAGNODE-3) evaluating retogatein (rhGAD65) in individuals with Stage 3 type 1 diabetes. The outcome of interim analysis readout is expected by the end of March 2026. The interim analysis is based on data from 174 evaluable participants. The primary endpoint of the interim analysis is change from baseline to Month 15 in stimulated C-peptide area under the curve (AUC), reflecting preservation of endogenous insulin production, and is intended to provide an assessment of treatment effect in the study population. In line with the company's regulatory strategy, positive interim result would support engagement with regulatory authorities to discuss possible approval pathways for retogatein. The interim analysis will assess the efficacy of retogatein compared to placebo and test whether predefined criteria for statistical significance are met. An independent Data Safety Monitoring Board (DSMB) will review the interim result and accumulated safety data. The company intends to communicate the outcome of the DSMB meeting, including whether statistical significance was met for the primary endpoint, as well as an update on the DSMB's safety assessment of the ongoing trial. DIAGNODE-3 is a randomized, double-blind, placebo-controlled confirmatory Phase 3 trial evaluating intrymphatic administration of retogatein formulated with alum in children, adolescents, and young adults newly diagnosed with Stage 3 type 1 diabetes who carry the HLA DR3-DQ2 haplotype. This genetic profile is present in approximately 40% of individuals with type 1 diabetes in Europe and the United States. The primary readout will be based on baseline to 15-month data for all randomized participants after which participants will continue to be followed for a total of 24 months. DIAGNODE- 3 is supported, in part, by funding from Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes research and advocacy organization. Retogatein has received Fast Track Designation from the FDA for the treatment of type 1 diabetes across Stages 1-3, as well as Orphan Drug Designation for Stage 3 type 1 diabetes. Tillkännagivande • Jan 28
Diamyd Medical AB (publ) to Report Q3, 2026 Results on Jul 24, 2026 Diamyd Medical AB (publ) announced that they will report Q3, 2026 results on Jul 24, 2026 Tillkännagivande • Jan 12
Diamyd Medical Announces Completion of Screening in Pivotal Phase 3 DIAGNODE-3 Trial Diamyd Medical announced that the screening period in its pivotal Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in individuals with type 1 diabetes has been completed. Based on the number of patients screened, the Company expects approximately 310-320 participants to be randomized into the trial once enrollment is completed, which is expected by early March. DIAGNODE-3 is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating retogatein in genetically defined individuals with Stage 3 type 1 diabetes. Retogatein is an investigational antigen-specific immunotherapy designed to preserve endogenous insulin production. By inducing antigen-specific immune tolerance to GAD65, retogatein aims to modulate the autoimmune response responsible for beta-cell destruction, potentially slowing or halting disease progression. As previously communicated, following a Type C meeting with the U.S. Food and Drug Administration (FDA), Diamyd Medical has aligned with the FDA to accelerate the primary efficacy readout in DIAGNODE-3 from 24 to 15 months, while maintaining a robust assessment of treatment efficacy. This adjustment enables the full primary efficacy data to be available approximately nine months earlier than originally planned. The previously announced interim efficacy analysis, based on approximately 170 participants with 15-month follow-up, remains on track for the end of March 2026. Retogatein has received Fast Track Designation from the FDA for the treatment of type 1 diabetes across Stages 1-3, as well as Orphan Drug Designation for Stage 3 type 1 diabetes. Tillkännagivande • Dec 13
Diamyd Medical Finalizing Phase 3 Screening as Gmp Review Progress Diamyd Medical announced that the number of randomized participants in DIAGNODE-3, Diamyd Medical's registrational Phase 3 trial in type 1 diabetes, has now exceeded 290, and the screening will conclude in the coming weeks. The interim efficacy analysis of approximately 170 participants with 15-month data is scheduled for end of March 2026. The Company also confirms that its Umea manufacturing facility is currently under review by the Swedish Medical Products Agency as part of the GMP-certification process. Enrollment continues to progress according to plan in DIAGNODE- 3, the Company's registrational Phase 3 trial evaluating Diamyd in individuals aged 12 to 28 with recently diagnosed Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 genotype. With more than 290 participants enrolled and screening to conclude shortly, the study is approaching the planned interim efficacy readout. The interim efficacy analysis will include approximately 170 evaluable participants assessed after 15 months follow-up in the trial and focuses on stimulated C-peptide as an endpoint. The analysis was designed in alignment with FDA feedback to maintain the registrational integrity of the trial while enabling the potential for an accelerated Biologics Licensing Application. The trial has previously passed several independent safety reviews and a futility analysis, each recommending continuation without modification. Diamyd is being developed as a precision-medicine, antigen-specific immunotherapy aimed at preserving endogenous insulin production in genetically defined individuals. The FDA has granted Fast Track Designation for Diamyd across Stages 1-3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed C-peptide as a acceptable surrogate endpoint that can support an accelerated approval pathway in the US. The Company's 2,200 m2 manufacturing facility-for the manufacture of recombinant GAD65, the active ingredient in Diamyd-is currently under formal review for GMP certification from the Swedish Medical Products Agency. GMP certification will enable manufacture of clinical-grade material and represents an important step toward approval for commercial manufacturing as part of a Biologics Licensing Application". Tillkännagivande • Dec 05
Diamyd Medical AB (publ), Annual General Meeting, Dec 04, 2025 Diamyd Medical AB (publ), Annual General Meeting, Dec 04, 2025. Tillkännagivande • Nov 16
Diamyd Medical's Pivotal Phase 3 Type 1 Diabetes Trial Clears Last Safety Review Ahead of Early Readout in March 2026 The independent Data Safety Monitoring Board (DSMB) has completed its sixth scheduled safety review of Diamyd Medical's registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd®?. The review identified no safety concerns and resulted in a recommendation to continue the trial as planned. DIAGNODE-3 is conducted under Fast Track and Orphan Drug Designations granted by the U.S. Food and Drug Administration (FDA), with an agreement in place that an early efficacy readout planned for March 2026 may serve as the basis for a Biologics License Application (BLA) under the FDA's accelerated approval pathway. The DSMB is an independent committee of clinical experts that monitors safety and efficacy in ongoing studies. This positive review further strengthens the favorable safety profile of Diamyd®?. To date, 285 patients have been enrolled in DIAGNODE-3. Of these, more than 70 patients have completed the full 24-month follow-up, and more than 135 have completed their 15-month visit. Tillkännagivande • Nov 13
Diamyd Medical AB (Publ) Receives Positive Feedback from the US Food and Drug Administration Regarding the Possible of Earlier Market Approval Diamyd Medical AB (publ) is in an expansive phase where positive feedback has been received from the US Food and Drug Administration (FDA) regarding the possibility of earlier market approval. The development in type 1 diabetes has never had greater momentum, supported by a regulatory environment increasingly favoring disease-modifying therapies. With the FDA's fast track and orphan drug designations for investigational therapy Diamyd®?, the recognition of C-peptide as a surrogate marker that can support an accelerated approval pathway, and the approval of the disease-modifying drug TZIELD®? (teplizumab), there is now clear regulatory alignment and growing payer recognition of the value of preserving the body's own insulin production. Diamyd Medical is leading the development of precision medicine and antigen-specific immunotherapy for type 1 diabetes. The antigen-specific immunotherapy Diamyd®? combines genetic precision, a favorable safety profile, and clinical usability, defining a new class of targeted treatments that address the underlying cause of the disease. Tillkännagivande • Oct 04
Hong Kong Grants Precision Medicine Patent to Diamyd Medical for Insulin Antigen Treatment in Type 1 Diabetes Diamyd Medical has been granted a patent in Hong Kong protecting the use of insulin-based antigens to treat individuals with type 1 diabetes carrying the HLA DR4-DQ8 genetic marker. The patent is valid until 2038 and further strengthens the company's global IP portfolio in precision medicine for type 1 diabetes. Treatment and prevention of type 1 diabetes in individuals carrying HLA DR3-DQ2 using Diamyd®? (GAD/alum) is granted in Europe, Eurasia, Hong Kong, Israel, Japan, South Africa and South Korea, with patent protection extending to 2038. Applications for additional countries are currently pending. Treatment and prevention of type1 diabetes in individuals carrying HLADR4-DQ8 using insulin as an antigen is granted in Europe, EurasIA, Hong Kong and South Korea, with patent Protection also lasting until 2038, and is pending in several other territories. Together, these two genetic markers - HLA DR3-D Second Quarter and DR4-DQ8 - are present in up to 90% of individuals with type 1 diabetes, underscoring their broad clinical relevance. Tillkännagivande • Sep 13
Diamyd Medical AB (publ) to Present New Analysis at EASD Annual Meeting Diamyd Medical announced that a new retrospective analysis of clinical data from 241 individuals with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genetic marker has been accepted for oral presentation at the European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria, 15-19 September. The analysis reinforces previous findings, demonstrating that treatment with Diamyd (rhGAD65/alum), a precision medicine immunotherapy currently being evaluated in the pivotal Phase 3 trial DIAGNODE-3, leads to longer preservation of insulin production compared to placebo. The analysis combined data from three clinical trials involving 241 individuals (median age 13) diagnosed with stage 3 (clinically diagnosed symptomatic) type 1 diabetes within the last six months. All individuals carried the HLA DR3- Diamyd (as in the ongoing DIAGNODE-3 trial), 2 injections, or a placebo, on top of standard of care insulin treatment. Treatment with at least 3 injections of Diamyd significantly delayed the disease progression to an insulin response below 0.2 nmol/L (p = 0.001) - a level important for reducing future diabetes complications. In the placebo group, half of the participants dropped below 0.2 nmol-L after 14.6 months. For those receiving Diamyd, fewer than half reached this level during the study, indicating that their insulin production was preserved for significantly longer. Treatment with at least 3 injection of Diamyd significant delayed the disease progression to an diabetes response below 0.5 nmol/L (p= 0.015) - a level linked to better blood sugar control. In the placebo group, Half of the participants dropped below 0.,5 nmol/L after 8.8 months. For those receiving at least 3 doses of Diamyd, this decline took 14.5 months, showing that their insulin production was preservedfor significantly longer. The findings will be presented on September 18, 2025 by Anton Lindqvist, CSO of Diamyd Medical, in the oral session "Next-generation therapeutics: novel approaches to diabetes and obesity" at the EASD Annual Meeting in Vienna. Diamyd Medical will also present at the "The Life- Changing T1D Therapies INNODIA Symposium" on September 15, 2025. Tillkännagivande • Jun 25
Diamyd Medical AB (publ) to Report Fiscal Year 2025 Final Results on Nov 13, 2025 Diamyd Medical AB (publ) announced that they will report fiscal year 2025 final results on Nov 13, 2025 Tillkännagivande • May 01
Diamyd Medical AB (publ) has completed a Composite Units Offering in the amount of SEK 220.892824 million. Diamyd Medical AB (publ) has completed a Composite Units Offering in the amount of SEK 220.892824 million.
Security Name: B Units
Security Type: Equity/Derivative Unit
Securities Offered: 27,611,603
Price\Range: SEK 8
Transaction Features: Rights Offering Tillkännagivande • Apr 30
Diamyd Medical AB (publ) has completed a Composite Units Offering in the amount of SEK 202.22 million. Diamyd Medical AB (publ) has completed a Composite Units Offering in the amount of SEK 202.22 million.
Security Name: B Units
Security Type: Equity/Derivative Unit
Securities Offered: 25,277,500
Price\Range: SEK 8
Transaction Features: Rights Offering Tillkännagivande • Apr 28
Europe to Grant Precision Medicine Patent to Diamyd Medical for Insulin Antigens Treatment in Autoimmune Diabetes The European Patent Office (EPO) has informed Diamyd Medical that the patent application protecting the use of insulin-based antigens for the treatment of autoimmune diabetes in patients carrying the HLA DR4-DQ8 geneticmarker will be granted. The patent, valid until 2035, marks an important step in advancing precision medicine for diabetes care. The forthcoming EPO patent grant builds on the foundation already established for patients with the HLA DR3-DQ2genotype, a distinct genetic subgroup currently targeted by Diamyd Medical's GAD-specific immunotherapy Diamyd®? in the ongoing Phase 3 DIAGNODE-3 trial. Research also indicates that individuals with the DR4-DQ8 profile could benefit from insulin-specific immunotherapy. Together, HLA DR3-D Second Quarter and DR4-DQ8 markers are present in up to 90 % of individuals with Type 1 Diabetes, emphasizing their clinical relevance. Tillkännagivande • Apr 21
Diamyd Medical Highlights Opportunity in Type 1 Diabetes Prevention, Adult-Onet Market, and Upcoming Phase 3 Readout Diamyd Medical highlights opportunity in Type 1 Diabetes prevention, adult-onset autoimmune diabetes (LADA) segment increasingly recognized as part of the Type 1 Diabetes spectrum, and the major milestones ahead - including a registrational Phase 3 readout expected within 12 months. Diamyd is a precision immunotherapy targeting individuals with a specific HLA genotype associated with Type 1 Diabetes. Over 1,000 patients have been treated with Diamyd, a durable investigational antigen-specific GAD-based therapy, giving it a robust safety track record. The treatment aims to preserve endogenous insulin production by reprogramming the immune system-addressing the root cause of the disease rather than just managing blood glucose. A precision platform with broad reach. Diamyd Medical's approach is built around matching therapy to the patient's genetic profile. The Company is currently enrolling only patients with the appropriate HLA genotype in its Phase 3 trial DIAGNODE-3. Diamyd Medical is also taking steps to broaden its precision medicine platform. A strong case for impact and market adoption. Beyond the scientific and regulatory readiness, the Company sees strong commercial potential. Tillkännagivande • Apr 17
The Prevention Trial Diamyd Medical AB (publ) Cares First Safety Milestone Diamyd Medical announced the first safety review in the ongoing DiaPrecise trial in individuals with Stage 1 and Stage 2 Type 1 Diabetes has been successfully completed by the independent Data Safety Monitoring Board (DSMB), following treatment of the initial three participants. The DSMB reported no safety concerns related to the injection procedure or investigational medicine, supporting continued subject enrollment. Additional participants are currently in the screening phase. DiaPrecise is the first clinical trial to assess the safety of the targeted administration of Diamyd®? in a superficial lymph node in children and adolescents with presymptomatic Type 1 Diabetes (Stage 1 and Stage 2) carrying the genetic profile that has been associated with positive response in previous clinical trials (HLA DR3-DQ2). The trial is a key part of the Diamyd Medical's strategy to position Diamyd®? as a precision immunotherapy capable of delaying - or ideally halting - the onset of clinical (Stage 3) Type 1 Diabetes. DiaPrecise is conducted under the ASSET program (AI for the Sustainable Prevention of Autoimmunity in Society, funded by the Swedish Innovation Agency VINNOVA. In parallel, Diamyd Medical is collaborating with DiaUnion, a Nordic cross-border initiative advancing early treatment and screening programs for autoimmune diabetes. Treat treating presymptomatic states and incorporating a precision medicine approach reflects a broader shift in diabetes care - from reactive treatment to proactive prevention. With a well-established safety profile, based on a comprehensive database of over 1,000 treated individuals, and a straightforward, minimally invasive injection procedure, Diamyd®? is uniquely suited for early-stage use, particularly in children identified through national or regional screening programs. This is supported by a follow-up of a previous prevention trial, DiAPREV-IT, presented at the 2024 ISPAD Congress, suggesting that Diamyd®? could delay progression to Stage 3 Type 1 Diabetes by up to seven years in children with Stage 1 or Stage 2 Type 1 Diabetes and HLA DR3-DQ2. T1D will form the pilot project for the program, but the goal is extending the functionality to other indications including other autoimmune diseases that are strongly linked to T1D such asliac disease (gluten intolerance) and autoimmune thyroiditis (inflammatory disease of the thyroid gland). Prevent: ASSET aims to be a test-bed for clinical development, with the ongoing DiaPrecise trial testing a precision medicine approach to early stage T1D. Implement: ASSET will study organizational, economic, and legal prerequisites and consequences of applying the approach as a tool for precision health in the Swedish health care system. The goal is to proactively manage obstacles that can slow down the implementation and spread of the innovations in the healthcare system. Tillkännagivande • Feb 07
Diamyd Medical Receives Patent Protection in the US and Japan for Gaba Formulation Remygen Diamyd Medical announced that the US Patent and Trademark Office (USPTO) and the Japanese Patent Office have informed Diamyd Medical that they will grant the patent for the Company's oral formulation of the GABA-based study drug Remygen. Remygen is currently in Phase 2 development through the ReGenerate-1 trial in individuals with long-term Type 1 Diabetes. Results are expected later this quarter. In addition to the Remygen formulation patent, Diamyd Medical holds an exclusive license from the University of California, Los Angeles (UCLA), for treating diabetes and other inflammatory disorders with GABA alone and in certain combinations including GABA receptor modulators and antigen-specific immunotherapies. Diamyd Medical has also filed patents on GABA's therapeutic effect on the hormonal counter-regulatory response to low blood sugar levels. Remygen is Diamyd Medical's proprietary formualtion of GABA, a key cell signalling molecule in the islets of Langerhans found in the pancreas. GABA has been shown to affect the secretion of insulin and glucagon both in healthy volunteers and in patients. Preclinical studies have shown strong indications that GABA stimulates the growth and function of the insulin and glucagon producing cells in the pancreas. Preclinical studies have also shown that GABA receptor modulating agents such as Alprazolam may increase the positive effect of GABA on the insulin producing cells. ReGenerate-1 is an open-label, investigator initiated clinical trial involving a total of 35 patients aged 18-50 who have had type 1 diabetes for longer than five years with low to non-existing residual insulin production. The trial is conducted at Uppsala University Hospital with Professor Per-Ola Carlsson as Principal Investigator. The trial consists of two parts; an initial safety and dose escalation part comprising six patients, and the main trial, which comprises 35 patients who will be followed up to nine months depending on the dose group to which they belong. The main purpose is to evaluate the safety of Remygen and the combination of Remygen and the GABA receptor-modulating substance Alprazolam. The trial will also examine whether Remygen alone and in combination with Alprazolam can have a positive effect on the hormonal counter-regulatory response to low blood sugar and on the restoration of beta cell function, potentially allowing in the long run a patient to regain insulin producing capacity. 
