Diamyd Medical Progresses Towards Accelerated Approval from FDA for Type 1 Diabetes Therapy

Positive Developments for Diamyd Medical

Diamyd Medical has recently announced a significant advancement in its quest for an accelerated approval of its innovative diabetes therapy, Diamyd® (rhGAD65/alum). Following a productive Type C meeting with the U.S. Food and Drug Administration (FDA), the company has achieved alignment on essential elements concerning an early readout and the regulatory pathway required to facilitate quicker access to this vital treatment.

Meeting with the FDA

During the in-person meeting, executives from Diamyd Medical engaged in substantial dialogue with FDA representatives. Ulf Hannelius, the CEO of Diamyd Medical, expressed his satisfaction with the positive and constructive nature of these discussions. Achieving alignment on the accelerated readout procedure marks a crucial milestone on the path to making the Diamyd® therapy widely available to individuals suffering from Type 1 Diabetes, particularly those in need of treatments that can modify the disease.

This alignment signals a potential to bring Diamyd® to the market over a year earlier than previously anticipated. This is especially crucial given the pressing demand for innovative therapeutic options for those affected by this chronic condition.

Upcoming Trials and Efficacy Data

The early readout is scheduled for March 2026 as part of the ongoing Phase 3 DIAGNODE-3 trial, which is currently evaluating around 170 participants who have completed a 15-month assessment. As of now, 191 participants have been randomized in this critical trial. The initial analysis will focus on preserving C-peptide levels—an important biochemical marker that indicates insulin production. The FDA has recognized C-peptide levels as a reasonable surrogate endpoint that could be used to facilitate accelerated approval based on the outcome of this trial.

About Diamyd® and Its Development

Diamyd Medical specializes in precision medicine, focusing on therapies that target Type 1 Diabetes and Latent Autoimmune Diabetes in Adults (LADA). The company’s flagship product, Diamyd®, is designed to be an antigen-specific immunomodulatory treatment aimed at ensuring the preservation of the body’s natural insulin production capabilities.

Notably, Diamyd® has received Orphan Drug Designation in the U.S. and has also earned Breakthrough and Fast Track Designation from the FDA for treating Stage 3 Type 1 Diabetes. Additionally, it holds Fast Track Designation for treating earlier stages of the disease. The ongoing DIAGNODE-3 trial is actively recruiting participants at 60 clinics across eight European countries and the United States, expanding its reach and potential impact.

Innovative Treatment Approaches

The approach utilized in the trial involves direct injection of Diamyd® into a lymph node, a method that takes merely a few minutes and aims to optimize patient responses to treatment. Favorable data has already been observed in a large genetically predefined cohort during previous trials, including significant outcomes from a European Phase IIb study and a comprehensive meta-analysis of multiple studies.

Furthermore, a biomanufacturing facility is in the works in Umeå, Sweden. This facility will be dedicated to producing recombinant GAD65 protein, the active component of Diamyd®. In addition to developing Diamyd®, the company is also focused on creating the investigational drug Remygen®, derived from GABA, for use in treating metabolic diseases. Diamyd Medical is a significant stakeholder in both NextCell Pharma AB, a stem cell company, and MainlyAI AB, which specializes in artificial intelligence solutions.

Looking Ahead

Diamyd Medical's shares are traded on the Nasdaq First North Growth Market under the ticker DMYD B. The company's strategic partnerships, alongside its promising advancements in diabetes therapies, paint a hopeful picture for those affected by this challenging condition. Upon receiving the final meeting minutes from the FDA early next year, further details will illuminate the path forward for this innovative treatment.