SHANGHAI, CHINA- Ark Biosciences, a biotech company developing proprietary therapeutics for respiratory viral diseases and viral hepatitis, today announced the successful completion of phase 1 clinical study of its anti-respiratory syncytial virus (RSV) drug AK0529.

AK0529 is a structurally novel anti-RSV drug being developed for the treatment of acute RSV infection. The orally administered drug specifically inhibits RSV replication by blocking viral entry and syncytium formation, the latter a unique viral transmission and cell-cell fusion phenomenon which gives the virus its name. AK0529 demonstrates potent antiviral activity across multiple strains of RSV in vitro and represents an important step forward in the development of effective therapeutics for this serious and often life-threatening infection.

In a randomized, double-blind, placebo-controlled phase 1 study of orally administered AK-0529, safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses were evaluated. The study was conducted in a well-known Australian clinical research unit.

“We are pleased to announce the successful completion of AK0529's phase 1 clinical trial,” stated Dr Jim Wu, Founder and Chief Executive Officer of Ark Biosciences. “This represents a significant step in the development of AK0529 as an effective first-line antiviral therapy for RSV infection in infants and the elderly”.

Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, commented “We received top-line results from our AK0529 phase 1 study. The safety and pharmacokinetics of AK0529 were evaluated in both single and multiple ascending doses. The drug was well tolerated, with an excellent safety profile and no serious adverse events, right up to the maximum administered dose of 1200 mg". Ark is now progressing the development of AK0529, with commencement of a study in hospitalized patients and will in due course present further clinical results.

Details of the phase 1 clinical trial results were delivered in oral presentation at the 1st International Meeting on Respiratory Pathogens in Singapore on September 3rd, 2015 (1st ISIRV-IMRP).

About RSV

RSV is one of the most infectious known human viruses, infecting 3-10% of the world's population every year. RSV infection is the leading cause of death in children under 5 years old, and is the most common cause of acute lower respiratory tract infection (LRTI) in infants and children, being particularly prone to causing very small airway inflammation and obstruction, or 'bronchiolitis'. Globally, RSV accounts annually for 34 million cases of LRTI, and up to two hundred thousand deaths in children under 5 years old every year. RSV is also a significant problem for the elderly, who suffer a very high rate of severe lung infection and death. Additional high risk patient populations include immunocompromised adults, as well as those with chronic lung conditions, congenital heart disease, and chronic obstructive pulmonary disease (COPD). There is no vaccine available to protect against RSV infection. Current therapy for those ill with RSV infection involve symptomatic or supportive care. Comments Dr Jim Wu, "There is currently a huge unmet medical need for an antiviral to treat RSV infection".

About Ark Biosciences

Ark Biosciences is a privately held, clinical stage biotechnology company located in ZhangJiang Hi-Tech Park in Shanghai, China, with offices in Australia and Basel, Switzerland. Ark Biosciences has its own active R&D programs and licenses drug assets for clinical development in the Asia-Pacific region. Through these efforts, Ark Biosciences aims to be a global biotechnology company, discovering and developing antiviral and pediatric drugs. For more information, please visit www.arkbiosciences.com.