Phase II Trial Launched of AAT for the Prevention of Lung Transplant Rejection

Kamada has initiated a Phase II clinical trial with its proprietary Alpha-1 Antitrypsin (AAT) for the prevention of lung transplant rejection. The trial is a randomized, open-label, single-site study of 30 lung transplant recipients to evaluate the safety and efficacy of intravenous (IV) AAT in addition to standard-of-care (SOC) versus SOC. Twenty patients will receive IV AAT treatment every other day for 14 days and then once every two weeks until week eight when they will receive monthly treatments. The 10 other patients will be treated with SOC, which includes systemic corticosteroids and immunosuppressants. Following one year of AAT treatment, there will be a one year follow-up. The primary endpoints of the study include safety and tolerability, the incidence of acute lung transplant rejection and changes in forced expiratory volume from baseline and overall effect. Additional endpoints include various inflammatory biomarkers and functional capacity.

“Lung transplantation can be a lifesaving procedure for those with end-stage lung diseases. Unfortunately, long-term graft and patient survival are limited by both acute and chronic allograft rejection, with a median survival of just over six years. Fully one-third of all lung transplant recipients experience acute rejection in the first year, and 40 percent will develop chronic rejection within the first five years,” said Professor Mordechai R. Kramer, MD, director of the Institute of Pulmonary Medicine, Rabin Medical Center, Beilinson Hospital. “Current treatment options such as immunosuppressants have limited efficacy and can have significant adverse side effects and comorbidities. Preclinical data published in Blood suggest that IV AAT has an immunomodulatory and anti-inflammatory mechanism of action that would support its efficacy in the prevention of lung transplant rejection.”

The study is being conducted at Rabin Medical Center, Beilinson Hospital in Israel in collaboration with Baxalta, which has distribution rights to the company’s IV AAT for all indications in the U.S., Canada, Australia and New Zealand.