Drug intelligence / Profile preview

BHT-3009 + atorvastatin

Development stage
Phase 1
Lead developer
Bayhill Therapeutics
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Small Molecules
Administration
Intramuscular (BHT-3009), Oral (atorvastatin)
01

Overview

BHT-3009 + atorvastatin is a **combination therapy** consisting of BHT-3009, a tolerizing DNA vaccine encoding full-length human myelin basic protein (MBP), and atorvastatin, a commonly used lipid-lowering statin. BHT-3009 is designed to induce **antigen-specific immune tolerance** and reduce autoimmune activity by presenting MBP in a tolerogenic context, thereby downregulating T cell- and autoantibody-mediated autoimmune responses thought to drive multiple sclerosis (MS)[3][1][2]. Atorvastatin, beyond its lipid-lowering action, has shown immunomodulatory effects in preclinical autoimmune disease models. The combination was investigated to test if statin-mediated immunomodulation could enhance the induction of tolerance generated by BHT-3009. Clinical data indicate that the combination was safe and well tolerated, but adding atorvastatin to BHT-3009 did not provide substantial additional benefit over BHT-3009 alone for immunological or clinical endpoints in MS patients[3][4].

02

Targets

HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase)MOG (Myelin oligodendrocyte glycoprotein)

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