NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today positive proof of concept data from a phase II, proof of concept study with its Inhaled Alpha-1 Antitrypsin (AAT) in bronchiectasis.
The results indicate that Inhaled AAT, via an optimized eFlow platform nebulizer (PARI Pharma GmbH), provides a positive indication as to its ability to decrease the inflammatory process in the lung. Furthermore, as reported previously, the safety profile demonstrated in this study is very good and is comparable to the one seen in previous studies with Kamada’s inhaled AAT.
The Phase 2 trial, conducted at the Rabin Medical Center in Israel, was a placebo controlled, double-blind, randomized trial that enrolled twenty one patients with bronchiectasis. Patients were randomized 2:1 to Inhaled AAT or placebo for 12 weeks. This study was designed to investigate safety and tolerability of Inhaled AAT and to explore its impact on lung inflammation.
David Tsur, Kamada’s CEO, stated, “Treatment options for patients with bronchiectasis are limited. We are very encouraged with the results observed in this study and previous studies so far.” David Tsur added, “The results from this study provide us with important information that will enable us to continue the development of Inhaled AAT for this and other indications, including alpha-1 antitrypsin deficiency which is currently our main focus.”
Professor Kramer, Head of the Pulmonary Institute at the Rabin Medical Center in Israel and Principal Investigator of the trial, said, “Kamada’s Inhaled AAT is a technological breakthrough that delivers AAT directly to the damaged site. This may provide a solution to the acute inflammatory process observed in bronchiectasis patients. It is my impression that the convenient use of the product, in addition to its high safety profile, could make it an innovative treatment for respiratory patients.”
About Inhaled AAT
Kamada’s Inhaled AAT is a high purity alpha-1 antitrypsin preparation that Kamada manufactures using sophisticated, in house developed chromatographic purification methods. The inhaled AAT utilizes an optimized eFlow platform nebulizer (PARI Pharma GmbH), has been designated an Orphan Drug for the treatment of bronchiectasis, alpha-1 deficiency and cystic fibrosis, in the U.S. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and seven years of exclusive distribution rights, if the company’s product is first on the market.
About the eFlow® Platform Nebulizer
The eFlow platform nebulizer, an electronic, portable nebulizer technology platform, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, the eFlow platform nebulizer can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible amount of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, the eFlow platform nebulizer helps reduce the burden of daily treatments.
About Kamada
Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials. Additional information is available at www.kamada.com.
Contact: Kamada Ms. Pnina Straus, +972-8-64-6472 Clinical Trials and IP Manager
