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news.Kamada has enrolled first patient into its pivotal clinical trial with its new compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.
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The Phase 2-3, multi-center, randomised, double-blind, placebo-controlled and international study is expected to evaluate the efficacy and safety of inhaled, human AAT in alpha-1 deficient patients with emphysema.
The company said that the trial will be conducted across several European countries. The study protocol has been designed in agreement with the EMEA under the product’s orphan drug designation status.
David Tsur, CEO of Kamada, said: “We are very pleased with the advancement of the trial and hope that the rate of enrollment would reflect the excitement of the patients of this potential new treatment. We recognise the importance of bringing this product to this unique patient population for whom, at the moment, there is no therapeutic resolution.