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. BHT-3021 is in a Phase I/II clinical trial in T1D. Enrollment in the dose escalation cohorts is complete and preliminary results have indicated evidence of beta cell preservation as well as reduction in HbA1c. Additional data will be available in first half of 2009. BHT-3009, the company’s product in multiple sclerosis, 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).

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 2009. Bayhill owns all worldwide marketing, distribution and manufacturing rights to each product candidate.