Bayhill Therapeutics to Present Correlation of Antibodies with Clinical Response to Treatment with BHT-3009 in Multiple Sclerosis
Abstract Presented at the 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis and 15th Annual Conference of Rehabilitation in MS
Baseline Auto-Antibody Levels Demonstrate Positive Correlation with Clinical Measures of Efficacy
PALO ALTO, Calif.--(BUSINESS WIRE)--Oct 14, 2010 - Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA™ platform to develop targeted autoimmune disease treatments, today announced that it will present at the 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis and 15th Annual Conference of Rehabilitation in MS in Gothenburg, Sweden, data from its concluded Phase 2 clinical trial showing that baseline blood plasma anti-MBP (myelin basic protein) profiles identify responders to BHT-3009 treatment. The abstract to be presented entitled “Baseline plasma anti-MBP antibody levels correlate with subject response to BHT-3009, a novel, antigen-specific tolerising DNA vaccine therapy for MS patients,” is being shown as poster #417 in poster session 1.
Data in the abstract indicate that BHT-3009 has the potential to be the first personalized medicine for MS patients, by selecting for patients with high anti-MBP antibodies in their blood. The best responders had an 86% reduction in brain MRI (magnetic resonance imaging) gadolinium-enhancing lesion and 77% reduction in new and enhancing T2 lesions compared to placebo. This group also had a 67% reduction in the annualized relapse rate compared to placebo.
Hideki Garren, MD, PhD, COO, CSO, EVP and Co-founder of Bayhill Therapeutics, commented, “We are pleased to report the identification of a simple blood-based biomarker that predicts responders to BHT-3009. The results reported here combined with the excellent safety and tolerability of BHT-3009 shown to date support further clinical testing, and make BHT-3009 potentially the first personalized treatment available for MS patients.”
ABOUT THE TRIAL
Two hundred and eighty nine patients with relapsing-remitting MS (RR-MS) were initially randomized in a phase 2 trial to receive intramuscular (IM) injections of either BHT-3009 or placebo for 44 weeks (treatment period). Of these patients, 87 participated in an Immunology Study in which plasma was collected at baseline. The level of anti-MBP antibodies in the plasma was measured using a peptide microarray to examine the correlation between anti-MBP levels and degree of benefit after treatment with BHT-3009.
About BHT-3009
BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) currently being evaluated for the treatment of multiple sclerosis (MS). Clinical results to date suggest that BHT-3009 reprograms the immune system to tolerize to, rather than attack, the myelin antigens in the central nervous system of MS patients. Designed to treat MS in a specific and targeted manner, BHT-3009 has the potential to effectively treat MS with fewer side effects and a superior administration profile compared to currently available MS therapies.
About Multiple Sclerosis (MS)
MS is a chronic autoimmune disease characterized by the immune system's attack on specific self-antigens, such as myelin basic protein (MBP), present in the myelin sheath of the central nervous system. This attack on myelin self-antigens leads to the onset of MS, characterized by symptoms of numbness, lack of coordination, blindness and paralysis.
According to an article published in The New England Journal of Medicine in 2006, MS is the most common non-traumatic cause of disability in young adults in the United States and Europe. According to the National Multiple Sclerosis Society (NMSS), an estimated 400,000 people in the United States have MS, while more than two million people are afflicted worldwide.
About Bayhill Therapeutics
Bayhill Thereapeutics is a clinical-stage biopharmaceutical company at the forefront of developing novel and targeted treatment candidates for autoimmune diseases. Leveraging its proprietary therapeutic BHT-DNA™ platform, the Company's product candidates have been designed to restore the immune system to its normal state, known as “tolerance,” by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact. Through a targeted and selective approach, Bayhill's product candidates have the potential to deliver superior efficacy, safety and tolerability relative to current therapies.
Bayhill is in active discussions with potential pharmaceutical partners for the further advancement of two BHT-DNA™-based disease modifying product candidates that have demonstrated safety, tolerability, and preliminary efficacy: BHT-3009, a treatment candidate poised to enter registration-supporting clinical trials in patients with multiple sclerosis (MS); and BHT-3034, a tolerizing DNA therapeutic for myasthenia gravis. BHT-3021, an investigational treatment for type 1 diabetes (T1D) arising from the same Tolerizing DNA platform and partnered with Genentech/Roche is currently being evaluated in an ongoing Phase I/II clinical study. For more information please visit www.bayhilltherapeutics.com/
Contact: Bayhill Therapeutics, Inc.
Hideki Garren, MD, PhD, 650-320-2800
COO, CSO, EVP and Co-founder
hgarren@bayhilltx.com
Posted: October 2010
