Bayhill Therapeutics is a clinical-stage
biopharmaceutical company leveraging its
proprietary therapeutic BHT-DNA™ platform
to develop a pipeline of novel and targeted
treatment candidates for autoimmune diseases.
Through a targeted and selective approach,
the Company’s product candidates are designed
to restore the immune system to its normal state,
known as “tolerance,” by eliminating specific,
harmful immune responses while leaving the
rest of the immune system intact.

There are no currently approved therapies capable of restoring tolerance. Bayhill’s novel treatment approach has the potential to demonstrate improved efficacy, safety and tolerability relative to available therapies. BHT-DNA™ is potentially applicable to any autoimmune disease in which the target protein self-antigen or self-antigens are known. Medical research indicates that 28 such autoimmune diseases have been identified, including multiple sclerosis (MS), type 1 diabetes (T1D) and myasthenia gravis (MG), all three of which are Bayhill’s initial indications of focus.

The Company’s two lead BHT-DNA™ product candidates have demonstrated positive safety, tolerability and preliminary efficacy in all completed clinical studies to date. The first, BHT-3009, signaled an ability to induce tolerance and potentially treat MS in a recently completed Phase II trial in patients with relapsing-remitting MS (RR-MS). A Phase IIb clinical trial to evaluate BHT-3009 in the same patient population is expected to commence by the end of 2008. The second, BHT-3021, is undergoing assessment in a Phase I/II clinical trial in T1D. Enrollment in the study is ongoing with top-line results expected during the first half of 2009.

In addition to these clinical pipeline products, Bayhill has a third treatment candidate in preclinical studies. BHT-3034 for the treatment of myasthenia gravis (MG) is expected to enter IND-enabling studies in 2008. Bayhill owns all worldwide marketing, distribution and manufacturing rights to each product candidate.