SHANGHAI, CHINA- Ark Biosciences (Ark), a biotech startup company focusing on innovative drug discovery and development, today announced a licensing agreement for Roche's Respiratory Syncytial Virus (RSV) drug candidate AK0529. The compound is a novel, small molecule inhibitor of RSV replication that targets virus’s key fusion (F) protein, preventing viral entry into host cells as well as inhibiting F protein induced cell-cell fusion.
RSV is one of the most infectious human viruses, which affects 3-10% of worldwide population annually. It is the most common cause of acute lower respiratory disease in infants and children, and is the leading cause of death in children under 5 years old and infant hospitalization. Additional high risk populations include immunocompromised adults, those with chronic lung conditions, congenital heart disease, chronic obstructive airways disease (COPD), and the elderly. Roche initiated the RSV drug discovery program and optimized the AK0529 compound to the stage that it is now ready for clinical studies.
"AK0529 was designed to be a first-in-disease drug candidate based on its excellent preclinical profile," said Jim Wu, founder and CEO of Ark. "We are very excited to extend the outstanding scientific efforts and antiviral drug development legacy of Roche, and to have the opportunity to carry forward the clinical development of AK0529. Our ultimate goal is to develop a first-in-disease anti-RSV therapeutic to help millions of patients suffering from RSV infection world-wide, especially the most vulnerable in our society, the young and the elderly."
Under the agreement, Ark will receive the full data documentation of RSV drug candidate AK0529 and drug product active pharmaceutical ingredient (API). In return, Roche will receive upfront payment, milestone and royalty payments. Ark has been granted the exclusive development, manufacturing, and worldwide sales and marketing rights with the rights to sub-license.