Diamyd
- Generic Name
- Diamyd
Diamyd Medical New publication highlights safety and potential benefits of redosing Diamyd precision medicine for Type 1 Diabetes
A new publication by Diamyd Medical highlights the safety and potential benefits of redosing Diamyd® precision medicine for Type 1 Diabetes, based on the DIAGNODE-B pilot trial. The trial demonstrated stabilized endogenous insulin production, improved glycemic control, and reduced insulin requirements among participants.
Diamyd's GAD-Alum Redosing Shows Promise in Type 1 Diabetes
• A pilot trial, DIAGNODE-B, investigated the safety and efficacy of redosing Diamyd® (GAD-Alum) in Type 1 Diabetes patients.
• The study demonstrated that redosing Diamyd® was well-tolerated, with no severe adverse events reported during the 12-month follow-up.
• Participants experienced stabilized insulin production, improved glycemic control, and reduced insulin requirements after redosing.
• Immunological markers indicated sustained immune modulation, suggesting a potential long-term benefit of Diamyd® redosing.
Diamyd Medical Advances Toward Accelerated Approval for Diamyd® in Type 1 Diabetes
• Diamyd Medical received positive feedback from the FDA on its Phase 3 DIAGNODE-3 trial, aligning with requirements for Accelerated Approval based on interim efficacy data.
• The FDA concurred on the suitability of the safety dataset and confirmatory evidence, including data from DIAGNODE-3 and previous trials, for potential accelerated approval of Diamyd®.
• Agreement was reached with the FDA on evaluating stimulated C-peptide levels and HbA1c as co-primary endpoints at the 24-month final analysis for both accelerated and full approvals.
• Breakthrough T1D is providing Diamyd Medical with USD 1.75 million in expanded support for the DIAGNODE-3 Phase 3 trial, facilitating a potential regulatory filing for approval.
Diamyd Medical's DIAGNODE-3 Trial Reaches Recruitment Milestone, Eyes Accelerated Approval
• Diamyd Medical's DIAGNODE-3 trial, a Phase 3 study for Type 1 Diabetes, has recruited 180 patients, surpassing the target for its early readout planned in March 2026.
• The early readout is designed to support a potential accelerated Biologics License Application (BLA) submission to the FDA, leveraging the Fast Track designation.
• DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes, focusing on preserving endogenous insulin production.
• The trial will continue recruitment to ensure comprehensive data collection from approximately 330 patients, followed for 24 months, to further assess Diamyd's efficacy.
Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target, Anticipates Early Readout
• Diamyd Medical's DIAGNODE-3 Phase 3 trial has recruited 180 patients, surpassing the target for its early readout planned in March 2026.
• The early readout is intended to support a potential accelerated Biologics License Application (BLA) for Diamyd®.
• DIAGNODE-3 assesses Diamyd®, an antigen-specific immunotherapy, in individuals with newly diagnosed Stage 3 Type 1 Diabetes, focusing on preserving insulin production.
• The FDA has granted Diamyd® Fast Track designation and acknowledged C-peptide as a surrogate endpoint, potentially accelerating its approval pathway.
Diamyd Medical's DIAGNODE-3 Trial Exceeds Recruitment Target, Anticipates Early Readout
• Diamyd Medical's DIAGNODE-3 Phase 3 trial, evaluating Diamyd® for Type 1 Diabetes, has reached its initial recruitment target of 180 patients.
• This milestone supports an early data readout expected around March 2026, potentially enabling an accelerated Biologics License Application (BLA) submission.
• The trial assesses Diamyd®'s ability to preserve endogenous insulin production in a genetic subgroup of individuals with newly diagnosed Stage 3 Type 1 Diabetes.
• DIAGNODE-3 is continuing recruitment to reach a total of approximately 330 patients to ensure comprehensive data collection over 24 months.
Diamyd Medical's DIAGNODE-3 Trial Reaches Recruitment Milestone, Eyes Accelerated Approval
• Diamyd Medical's DIAGNODE-3 Phase 3 trial, evaluating Diamyd® for Type 1 Diabetes, has recruited 180 patients, surpassing the target for an early readout.
• The early readout, expected around March 2026, is designed to support a potential accelerated Biologics License Application (BLA) submission to the FDA.
• DIAGNODE-3 assesses Diamyd®'s ability to preserve insulin production and improve glycemic control in a genetic subgroup of individuals with Type 1 Diabetes.
• Diamyd® has received Fast Track designation and C-peptide is acknowledged as a surrogate endpoint, potentially expediting its approval for Type 1 Diabetes.
Diamyd's GAD-Alum Immunotherapy Shows Promise in Type 1 Diabetes Redosing Trial
• A clinical trial evaluating redosing of Diamyd's GAD-Alum immunotherapy in Type 1 Diabetes shows promising results, with sustained insulin production and improved glycemic control.
• The DIAGNODE-B pilot trial demonstrated the safety and tolerability of redosing GAD-Alum, with no severe adverse events reported during the 12-month follow-up.
• Data analysis reveals Diamyd significantly lowers the number, duration, and amplitude of hyperglycemic excursions, improving glycemic control in patients.
• Further analysis of Diamyd's clinical trials supports its potential as a precision medicine approach to slow Type 1 Diabetes progression, especially in HLA DR3-DQ2 positive patients.
Diamyd Medical Partners with INNODIA to Boost Type 1 Diabetes Trial
• Diamyd Medical collaborates with INNODIA to enhance patient recruitment for the DIAGNODE-3 trial, a Phase 3 study for Type 1 Diabetes.
• The partnership aims to increase awareness of Type 1 Diabetes and Diamyd® treatment across INNODIA's European clinical network.
• DIAGNODE-3 evaluates Diamyd®'s efficacy in preserving insulin production and improving blood glucose control in recent-onset Type 1 Diabetes patients.
• The collaboration supports Diamyd Medical's goal of a potential accelerated Biologics Licensing Application in the U.S. for Diamyd®.
Diamyd Medical Partners with INNODIA to Boost Type 1 Diabetes Trial
• Diamyd Medical collaborates with INNODIA to enhance patient recruitment for the DIAGNODE-3 trial, a Phase 3 study for Type 1 Diabetes precision medicine.
• The partnership aims to leverage INNODIA's European clinical network to increase visibility and enrollment in the DIAGNODE-3 trial.
• DIAGNODE-3 evaluates Diamyd®, an antigen-specific immunotherapy, in individuals recently diagnosed with Type 1 Diabetes and carrying the HLA DR3-DQ2 haplotype.
• The trial seeks to confirm the efficacy and safety of Diamyd® in preserving endogenous insulin production and improving blood glucose control.
Diamyd Medical Highlights Precision Medicine Approach for Type 1 Diabetes at ISPAD and IDS Conferences
• Diamyd Medical is presenting data at ISPAD and IDS conferences, emphasizing precision medicine's role in delaying Type 1 Diabetes progression.
• Follow-up data from the DiAPREV-IT trial suggests Diamyd® may delay progression to Stage 3 Type 1 Diabetes in children with the HLA DR3-DQ2 haplotype.
• Analysis of HLA DR3-DQ2 genotype variations reveals insights into Type 1 Diabetes heterogeneity, supporting the necessity of precision medicine.
• Diamyd® immunotherapy shows potential in improving glycemic control in HLA DR3-DQ2 positive patients, preserving endogenous insulin production.
Diamyd Medical Pursues Accelerated Approval for Diamyd® in Type 1 Diabetes
• Diamyd Medical is set to pursue an accelerated approval pathway in the U.S. for Diamyd® for Stage 3 Type 1 Diabetes.
• The FDA has acknowledged C-peptide levels as a surrogate endpoint, potentially expediting the approval process for Diamyd®.
• Interim data from the DIAGNODE-3 Phase 3 trial, expected around March 2026, will form the basis for the BLA submission.
• The DIAGNODE-3 trial is enrolling patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype across multiple sites.
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