Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company utilizing its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune and immune-mediated disease treatments, today announced the successful clearance of an IND with the US FDA for BHT-3034, a disease-modifying DNA plasmid vaccine immunotherapy for patients with the autoimmune neuromuscular junction disease myasthenia gravis. The IND was filed based on promising preclinical efficacy results showing significant disease severity attenuation and anti-acetylcholine receptor autoantibody reduction, as well as GLP toxicology studies showing no evidence of toxicity or immunogenicity. The IND also included a phase I/II dose escalation clinical study to treat up to 40 subjects with myasthenia gravis with 12 weekly doses of BHT-3034 intramuscularly.

“We are excited by this opportunity to bring forward a novel disease modifying therapy to patients with myasthenia gravis. BHT-3034 has the potential to significantly reduce the autoimmune response in a highly specific manner and thereby demonstrate a clinically meaningful benefit.”

Company founder and director Lawrence Steinman, MD, Chairman of the Interdepartmental Program in Immunology at Stanford University, stated, "We are excited by this opportunity to bring forward a novel disease modifying therapy to patients with myasthenia gravis. BHT-3034 has the potential to significantly reduce the autoimmune response in a highly specific manner and thereby demonstrate a clinically meaningful benefit."

This represents the third compound to enter clinical testing from Bayhill Therapeutics' proprietary BHT-DNA™ platform. The first compound, BHT-3009 for multiple sclerosis, has achieved success in a phase I/II trial where safety and antigen-specific immune tolerance was demonstrated, and in a phase II trial where a responder population of high serum anti-MBP (myelin basic protein) subjects demonstrated a > 70% reduction in brain lesions.

To move its programs forward in the most efficient manner, Bayhill Therapeutics also announced the retention of P² Partners, LLC to assist the Company in the pursuit of a strategic transaction.