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news.Biopharmaceutical company Icagen has announced that the FDA has accepted its investigational new drug application for senicapoc as a potential treatment for asthma.
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The company’s investigational new drug (IND) submission was supported by a growing body of data linking KCa3.1 to immune cell activation and cellular proliferation and efficacy data from a recently completed study that demonstrated the ability of senicapoc to reverse the antigen-induced changes in late phase airway resistance and airway hyper-reactivity in a sheep model of asthma.
The company also said that dosing of subjects in a Phase Ib clinical trial of senicapoc will begin in January. This study is designed to evaluate the safety, tolerability and pharmacokinetics of senicapoc administered orally once a day over a 28-day period at doses higher than those which have been used in previous clinical studies. The data from this study will be used to select doses for subsequent clinical evaluations of the safety and efficacy of senicapoc in asthma patients.