Kamada's Phase 2 Trial On Inhaled Alpha-1 Antitrypsin Meets Primary Endpoint

Kamada Ltd KMDA disclosed favorable top-line results of its second stage trial on inhaled Alpha-1 Antitrypsin that met primary endpoint.

The study is for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), which is an orphan disease treated by intravenous AAT augmentation therapy currently. Kamada indicated that patients were given its AAT for inhalation or placebo through the eFlow device for 12 weeks in the double-blind period. The company said primary efficacy steps included antigenic AAT levels and Anti-Neutrophil Elastase inhibitory levels in the lung and additional anti-proteolitic besides anti-inflammatory biomarkers.

CEO Amir London said, "We strongly believe our inhaled AAT has the potential to change the treatment paradigm for AATD. We intend to utilize the excellent results from this successful Phase 2 study to design a pivotal U.S. study and to support our responses to the EMA's 120-day comments in regards to Kamada's MAA for Inhaled AAT, which was submitted earlier this year. We also intend to continue our discussions with the U.S. Food and Drug Administration with this additional phase 2 data and the data from our EU phase 2/3 study in order to obtain guidance on the regulatory pathway for Inhaled AAT in the U.S."

Following the news, the stock traded up $0.35, or 7.73 percent, to $4.88 in the pre-market on Tuesday.