Successful trial for omalizumab biosimilar to treat allergic asthma- Sorrento Therapeutics
Sorrento Therapeutics has successfully completed a combined Phase II & III clinical study in China for STI-004, a biosimilar antibody for Xolair (Omalizumab). STI-004 met its primary endpoint in a multicenter, randomized, double-blind, placebo-controlled clinical trial. In the recently completed combined Phase II & III clinical study, STI-004 proved to be safe and efficacious in both adult and adolescent patients suffering from allergic asthma when compared to placebo.
In the 32-week study, asthma exacerbation was experienced by 21% of patients taking STI-004 as compared to 55% in the placebo group. In addition to significantly reducing asthma exacerbations, STI-004 demonstrated improved quality of life and pulmonary function while also reducing the dosage of budesonide and the use of asthma rescue medications. When compared to the currently marketed product, Xolair, the types and incidence rates of adverse events were similar.
Comment: Xolair (omalizumab) patents expire in January 2020 in the US and in August 2017 in the EU.
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