Israeli pharmaceutical company Kamada has initiated a US Phase 2 trial of its inhaled alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency, also known as inherited emphysema. The company also announced a delay in reporting results from a Phase 2/3 study of the product in Europe and Canada and said that it now expects to report top-line results from that study by the beginning of May 2014 and plans to present complete results at the ATS meeting in late May.
Kamada CEO David Tsur said, “We are very excited to initiate this US study of our inhaled AAT to treat AATD, which represents a potentially revolutionary, user-friendly, convenient and efficient treatment compared with the current AAT treatment that requires weekly invasive, intravenous infusions. The US market offers a significant opportunity to bring an inhaled therapy to patients suffering from this genetic lung disease, not merely as a more user friendly treatment, but also because the targeted delivery and treatment rationale directly to the lung are expected to enhance efficacy. Initiating this US clinical study is an important step in our global strategy to commercialize our novel, inhaled human AAT.”
Tsur continued, “We intend to use data from this US study along with the data from our European Phase 2/3 study to support a BLA license filing with the US Food and Drug Administration. Positive data from the Phase 2/3 study will also accelerate the variety of strategic options we are considering in the US, including licensing and/or proprietary sales by Kamada.”
The company also said that it plans to submit a marketing application to the EMA “in the second half of 2014, presuming a positive outcome to the study.” Chiesi acquired the rights to distribute the inhaled AAT in Europe, Turkey, and former CIS countries in 2012.
A US Phase 2 trial of inhaled AAT for the treatment of cystic fibrosis is planned for the second half of 2014 as well.
Read Kamada press release on new Phase 2 study.
Read Kamada press release on delayed results from current study.
