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news.The European regulator has approved Kamada's plan to begin phase I clinical trials on a respiratory form of its Alpha-1 proteinase inhibitor drug product for the treatment of congenital emphysema, a disorder of the lungs.
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An infusion form of the drug is currently undergoing advanced clinical testing with the FDA. The drug is used to treat congenital emphysema, caused by an in-born deficiency in Alpha-1 proteinase inhibitor.
According to the company, successful results of the clinical trials of the respiratory form the drug will mark a breakthrough in the treatment of congenital emphysema, as well as other lung disease indications.
The Israeli bio-pharmaceutical company applied to the European Agency for the Evaluation of Medicinal Products (EMEA) in February this year, and having been granted approval of its plan will work to speed up trial performance. Discussions between Kamada and EMEA have begun also on protocols of phase II and III of the clinical trials.
The product has been designated an orphan drug both in the US and in Europe for treating congenital emphysema and cystic fibrosis. This designation grants Kamada a range of support mechanisms such as research fund support, tax incentives, tolerance on fees and also a 7-year marketing exclusivity if the company’s inhaled API product will be the first on the market.