Diamyd Medical has achieved a significant milestone in its Phase III Diagnode-3 trial, reaching 180 enrolled patients. This achievement ensures a solid foundation for the upcoming data readout, anticipated in March 2026, which could be pivotal for the company's regulatory pathway.
The Diagnode-3 trial is designed to evaluate the efficacy and safety of Diamyd's lead candidate in individuals recently diagnosed with type 1 diabetes. The trial aims to demonstrate the drug's ability to preserve beta-cell function and potentially slow the progression of the disease. Recruitment will continue until approximately 330 patients have been included in the study.
According to Penser Access by Carnegie, the current number of enrolled patients should ensure that at least 170 patients will be able to be included as a basis for the upcoming data readout. In a recent mission analysis, Penser reiterated its fair value of SEK 35-45 for Diamyd Medical, reflecting confidence in the company's diabetes research program.
Type 1 diabetes is an autoimmune disease characterized by the destruction of insulin-producing beta cells in the pancreas. Current treatments primarily focus on managing blood sugar levels through insulin therapy, but do not address the underlying autoimmune process. Diamyd's investigational therapy aims to modulate the immune system and protect remaining beta cells, potentially offering a disease-modifying approach.
The Diagnode-3 trial's primary endpoint is to assess the change in stimulated C-peptide levels, a measure of beta-cell function, over a specified period. Secondary endpoints include assessing the impact on HbA1c levels, insulin requirements, and the incidence of diabetes-related complications. The trial includes patients recently diagnosed with type 1 diabetes, typically within a certain timeframe from diagnosis and meeting specific inclusion criteria related to age and disease stage.
Diamyd Medical's ongoing efforts in diabetes research represent a significant step towards addressing the unmet medical needs of individuals with type 1 diabetes. The results of the Diagnode-3 trial will be closely watched by the medical community and could potentially lead to a new treatment option for this chronic condition.
