#Sweden #Stockholm #Diamyd Medical #DIAGNODE-3 #retogatein

Diamyd Medical's DIAGNODE-3 Trial Update

Diamyd Medical, a pioneering entity in precision medicine targeting type 1 diabetes, has recently announced a significant milestone in its Phase 3 Clinical Trial dubbed DIAGNODE-3. The completion of the clinical database prepares the stage for a pre-specified interim efficacy analysis, allowing researchers and stakeholders to gain early insights into the potential effectiveness of their investigational treatment, retogatein (rhGAD65).

Ulf Hannelius, the President and CEO of Diamyd Medical, remarked on the importance of this development, noting that the interim analysis will provide the first Phase 3 evaluation of retogatein's capability to safeguard insulin production in a genetically-defined cohort of patients. This is particularly crucial as the treatment has been designed to help individuals diagnosed with Stage 3 type 1 diabetes, a chronic condition that affects insulin production in the body.

Understanding DIAGNODE-3

The DIAGNODE-3 trial has been structured as a randomized, double-blind, placebo-controlled study, systematically assessing the safety and efficacy of the intralymphatic administration of retogatein. This treatment is specifically aimed at children, adolescents, and young adults who have recently received a diagnosis of Stage 3 type 1 diabetes and possess the HLA DR3-DQ2 haplotype—a genetic profile seen in around 40% of afflicted individuals across Europe and the United States.

The analysis will evaluate the primary endpoint focusing on the change from baseline to Month 15 in the stimulated C-peptide area under the curve, serving as a proxy for the preservation of endogenous insulin production. By using data from 174 evaluable participants, the interim results could pave the way for crucial dialogues with regulatory authorities regarding potential pathways for retogatein's approval.

Efficacy Assessment and Next Steps

The forthcoming analysis will juxtapose the efficacy of retogatein against a placebo, seeking to establish whether certain pre-defined statistical significance criteria are achieved. For this purpose, an independent Data Safety Monitoring Board (DSMB) will rigorously assess the interim results alongside the consolidated safety data. Following their review, Diamyd Medical is committed to sharing the findings from the DSMB meeting, particularly regarding the statistical significance of the primary endpoint and the overall safety evaluation.

Funding and Future Directions

It's noteworthy that the DIAGNODE-3 trial is partly supported by Breakthrough T1D, a leading organization focused on research and advocacy for type 1 diabetes. This collaboration underscores the urgency and importance of advancing treatment strategies in this field.

Moreover, retogatein has been bestowed with Fast Track Designation by the FDA, reflecting the critical need for innovative solutions for type 1 diabetes, extending support across stages 1 to 3 of the disease. With ongoing advancements, a biomanufacturing facility for the production of retogatein is in development in Umeå, Sweden, which promises to streamline the supply of this innovative treatment.

As the DIAGNODE-3 trial approaches its full randomization expected by mid-March 2026, the stakes remain high for both the company and the patients involved. Early indications pointed towards significant outcomes in preserving endogenous insulin production in a genetically well-defined patient cohort from earlier studies, reinforcing hopes for a promising future in precision medicine for type 1 diabetes.

With the results anticipated by the end of March 2026, the medical community will be closely monitoring this trial, as the outcomes could potentially alter the treatment landscape for countless individuals battling this condition.