Drug intelligence / Profile preview

bht-3009

Development stage
Phase 2
Lead developer
Bayhill Therapeutics
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intramuscular
01

Overview

BHT-3009 is an investigational DNA vaccine that encodes full-length human myelin basic protein (MBP). It is designed to induce antigen-specific immune tolerance in patients with multiple sclerosis (MS) by altering the immune response to MBP, a key autoantigen implicated in MS pathogenesis. The drug works by delivering the MBP gene via plasmid DNA, leading to expression of MBP within antigen-presenting cells and subsequent tolerization of pathogenic T cells reactive to myelin antigens. Clinical trials have shown that BHT-3009 was safe and well tolerated, with evidence of reduced lesion activity on MRI and decreased clinical relapse rates in certain patient subgroups. However, overall efficacy results were mixed, and development for MS has been discontinued[1][2][3][4][5][6][8]. The drug was developed by Bayhill Therapeutics.

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