Kamada Ltd. announced interim results from the company’s Phase 2 trial of intravenous Alpha-1 Antitrypsin (IV AAT) for the prevention of lung transplant rejection. The study is being conducted in collaboration with Shire plc at the Rabin Medical Center - Beilinson Hospital in Israel, and is being led by Prof. Mordechai R. Kramer, M.D., Director of the Institute of Pulmonary Medicine at the Hospital. The Phase 2 trial is a randomized, open-label study of 30 lung transplant patients to evaluate the safety and efficacy of IV AAT to prevent lung transplantation rejection compared with standard-of-care treatment (SOC). The study is randomized 2:1, with 20 patients in the treatment group receiving IV AAT in combination with SOC (AAT+SOC), and 10 patients in the control group receiving SOC. This is a two-year study, with the first year consisting of an evaluation of treatment with AAT+SOC vs. SOC, and then an additional one-year of follow-up. In May 2017, the last of the 30 patients to be recruited entered the study and began treatment. The interim report summarizes data from the first six months of treatment for the initial 16 patients in the study. Ten of these 16 patients are in the AAT+SOC group, and six are in the SOC arm. To date, six patients have died (four patients in the AAT+SOC arm, and two in the SOC group) from common transplant-related complications unrelated to treatment with IV AAT. Out of the 10 total patients who lived throughout the six-month treatment period, four experienced acute rejection post transplantation, but survived and their situation improved and stabilized. Two of the patients who experienced the acute rejections were in the AAT+SOC arm, but their situation resolved without the need to change treatment; the other two patients were in the SOC group and their situation resolved, with one of them changing treatment. Moreover, pulmonary function, which is a key indicator of acute or chronic rejection, improved and was found to be stable in all 10 patients who are alive following six months of treatment. Kamada’s IV AAT demonstrated a favorable safety and tolerability profile, consistent with the results observed in previous clinical studies in different indications. None of the adverse events (AEs) or serious adverse events (SAEs) observed to date were considered to be related to treatment with IV AAT. During the six months of treatment, the six patients in the SOC group had a total of 28 AEs, while the 10 patients in the AAT+SOC arm had a total of 36 AEs. This represents a rate of 3.6 AEs and 2.5 AEs per 100 days of treatment in the SOC and AAT+SOC arms, respectively. Out of the 28 AEs in the SOC group, four were SAEs, while out of the 36 AEs in the AAT+SOC arm, three were SAEs. This represents a rate of 0.51 SAEs and 0.2 SAEs per 100 days of treatment in the SOC and AAT+SOC arms, respectively.