Swedish clinical-stage diabetes company Diamyd Medical (STO:DMYD-B) announced on Tuesday that it has received positive feedback from the US Food and Drug Administration (FDA) about an Accelerated Approval pathway for its immunotherapy, Diamyd, targeting Stage 3 Type 1 Diabetes patients with the HLA DR3-DQ2 genotype.
During a recent Type C Meeting, the FDA agreed that C-peptide could be used as a surrogate endpoint to predict the clinical benefit of preserving endogenous insulin production. This acknowledgment opens the possibility for Accelerated Approval based on significant treatment-related improvements in C-peptide levels due to Diamyd administration.
Ongoing discussions between Diamyd Medical and the FDA will clarify the requirements for a Biologics License Application (BLA) under this pathway, including an earlier readout from the ongoing Phase 3 DIAGNODE-3 trial.
Diamyd Medical focuses on precision medicine therapies for Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd has received Orphan Drug Designation and Fast Track Designation from the FDA for treating Stage 1, 2, and 3 Type 1 Diabetes.
The DIAGNODE-3 Phase III trial is currently recruiting patients with recent-onset Stage 3 Type 1 Diabetes in the US and eight European countries.
Sanofi commits USD18m to boost diversity in clinical studies
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
Anixa Biosciences administers second dose of CAR-T therapy to individual patient
Saniona reaches milestone in Boehringer Ingelheim partnership
Lipella granted patent for innovative drug delivery technology
SystImmune receives FDA clearance for Phase 1 trial of novel AML therapy
PTC Therapeutics' sepiapterin receives US FDA target regulatory action date
PharmAbcine's PMC-403 Phase one clinical trial single ascending dose cohort receives safety approval
RedHill Biopharma's opaganib selected for Ebola treatment development by BARDA
Exelixis and Merck collaborate on clinical development of zanzalintinib
BD launches automated reagent kit to streamline single-cell discovery studies
Transgene's Phase II trial of TG4001 falls short of primary objective
Lundbeck agrees to acquire Longboard Pharmaceuticals to enhance neuroscience pipeline