ZaBeCor Pharmaceuticals, a biotechnology company, has announced that the FDA has approved the company’s investigational new drug application for the treatment of asthma.
This approval enables the company to proceed with Phase I clinical trials in humans for its asthma drug candidate, Excellair. The investigational new drug (IND) review included ZaBeCor’s clinical development plan, Phase I clinical trial protocols, manufacturing plans and extensive preclinical studies.
According to the company, Excellair focuses on applications of siRNA to the molecular protein Syk kinase, which initiates the release of biologically active mediators in many inflammatory pathways, including those operable in asthma.
Excellair is said to be part of ZaBeCor’s extensive intellectual property and is based upon research conducted at the University of Pennsylvania School of Medicine.
Alan Schreiber, chairman and CEO of ZaBeCor, said: “This is an important milestone for ZaBeCor and indicates confidence in our intellectual property and data. We are delighted to continue the development of our asthma drug candidate, Excellair, which we believe will be a treatment for patients worldwide.”
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