Asklepion Pharmaceuticals concludes enrollment of Phase III trial: L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
BALTIMORE, July 01, 2019 (GLOBE NEWSWIRE) – Asklepion Pharmaceuticals, LLC (“Asklepion” or “the Company”), a biotechnology company focused on the development of novel therapeutics for rare pediatric diseases, today announced the completion of enrollment of its Phase III double-blind, randomized, placebo controlled, multi-center clinical study to evaluate the efficacy and safety of intravenous L-citrulline for the prevention of clinical sequelae of acute lung injury induced by cardiopulmonary bypass in pediatric subjects undergoing surgery for congenital heart defects. The study recruited 192 patients at 29 centers located in the USA, Israel, Germany and Austria.
“Asklepion is thankful for the incredible dedication shown by the clinical trial site teams as well as the families who participated in the trial. We are looking forward to learning the results of the trial and, if positive, to submit an application for regulatory approval. We hope to ultimately deliver a therapy which may lessen the severe complications associated with cardiopulmonary bypass surgery to provide pediatric patients with better post-surgical outcomes,” said Gary R. Pasternack, MD, PhD, Chief Executive Officer of Asklepion Pharmaceuticals. The results of the trial are expected in October 2019.
More information about the trial can be found on www.clinicaltrials.gov/ct2/show/NCT00335244.
Acute Lung Injury Induced by Cardiopulmonary Bypass
Children undergoing surgery for congenital heart problems are at risk for acute lung injury caused by the cardiopulmonary bypass surgery. Both the lung tissue and the blood vessels in the lungs can be damaged by CPB due to a primarily humoral inflammatory reaction, which can lead to significant heart and lung problems after surgery. In contrast to current methods of addressing the postoperative pulmonary dysfunction associated with cardiopulmonary bypass, all of which are remedial, citrulline is being evaluated as a preventive measure to avoid or reduce the risk of such sequelae of CPB.
L-citrulline
Citrulline is a urea cycle intermediate, an important precursor of nitric oxide and maintains coupling of endothelial nitric oxide synthase. Studies have shown that that cardiopulmonary bypass used for correction of congenital heart defects causes a significant decrease in urea cycle function with a large decrease in availability of urea cycle-derived precursors of nitric oxide synthesis.
Asklepion Pharmaceuticals
Asklepion Pharmaceuticals is a Baltimore-based, biotechnology company, focused on the discovery, development, and commercialization of endogenous pharmaceutical products to help patients who have little to no therapeutic options due to the rarity of their conditions.
For more information on the company, please visit www.asklepionpharm.com.
Contact:
410-545-0494
media@asklepionpharm.com
Investors:
Solebury Trout
Chad Rubin
crubin@soleburytrout.com
