Phase I/II
Design: Ongoing randomized placebo-controlled Phase I/II trial evaluating once-weekly intramuscular administration of BHT-3012 in up to 72 patients with T1D who are on a stable dose of insulin. Top-line results are expected in the first half of 2009
The trial is being conducted at U.S. sites and centers are opening in Australia, New Zealand, and Eastern Europe. Patients are randomized to receive either one of four dose levels of BHT-3021 (0.3 mg, 1 mg, 3 mg and 6 mg) or placebo, both administered intramuscularly once weekly for 12 weeks. After treatment patients are followed for 12 months, at which point placebo patients have the option to cross over and receive BHT-3021. All patients receiving BHT-3021 are being followed for 24 months.
Key objectives: Safety, pharmacodynamics, immune tolerance (measured by changes in antibodies or T cells against self-antigens), and changes in pancreatic function (measured by levels of insulin C-peptide in serum).
Safety Results: first 3 patients
Efficacy Results: Redux anti-insulin antibodies
Trial results to date
In the BHT-3021 phase I/II trial, nine patients have been randomized to the 1 mg dose cohort to date. BHT-3021 has demonstrated safety and tolerability, with no increase in adverse events among the first nine patients relative to placebo. Preliminary data also indicated that after the initiation of dosing with 1 mg of BHT-3021, there was a rapid reduction of approximately 50% in titers of anti-insulin antibodies that was sustained throughout the dosing period. In contrast, the anti-insulin antibody titers were unchanged with placebo dosing. Autoimmune T cell data from these initial patients are pending at this time.
