ALLOZYNE completes AZ01 Phase IA clinical trial in relapsing remitting multiple sclerosis

Jan 11 2011

ALLOZYNE, Inc. announced today, the completion of its first Phase IA clinical trial in healthy individuals for AZ01, a PEGylated form of human interferon beta-1b which is being developed for the treatment of relapsing remitting multiple sclerosis. The objectives of the Phase IA trial were to assess safety and tolerability profile in addition to defining its pharmacological properties. The results demonstrate that single administrations of AZ01 were well tolerated at all dosage levels tested. In addition, drug serum levels and interferon activity biomarkers were maintained well after administration in the highest dose groups indicating that once a month dosing may be a viable treatment regimen to pursue. In addition to the possibility of monthly dosing convenience, the data suggests that patients treated with AZ01 will experience a reduction in the days per month with flu-like symptoms and minimal to no injection site reactions. A multiple administration Phase IB trial is underway with results to be announced in mid 2011.

ALLOZYNE's President and CEO, Meenu Chhabra stated: "The treatment of MS is a rapidly evolving arena with the advent of orals and big gun immunomodulators in the last 5 years. That said, we are looking to address a specific unmet need in the largest portion of this $9 billion market which is to provide relief to the injection fatigued patient population from frequent dosing, injection site reactions and flu like symptoms. AZ01 offers the promise of a monthly dosing regimen without introducing additional safety risks. Thus, we are encouraged by the Phase IA results thus far and we remain cautiously optimistic about the probability of achieving monthly dosing which is heavily dependent on our manufacturing process. Thus, there will be a significant strategic focus in getting a commercial manufacturing process established in 2011. This will be a key value driver not just for AZ01 but also for our bioconjugation platform. Moreover, the observed AZ01 attributes, coupled with a longstanding interferon beta safety record, suggests that AZ01 will clearly differentiate itself from other late-stage MS therapeutics in development."