Ark Biosciences to Present at JPM Healthcare Conference in San Francisco
Date: Wednesday, January 15th, 2020
Time: 8:00AM (PST)
Room: Golden Gate (32nd Floor)
Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA94102 (USA)
The presentation will include updates on the progress made in the following key Ark programs:
Respiratory Syncytial Virus (RSV) Program
Ark Bioscience´s anti-RSV program successfully completed a global Phase II study (VICTOR) in 2019, demonstrating, for the first time ever, efficacy and clinical benefit of an antiviral in infants hospitalized with RSV infection. Ziresovir (AK0529), Ark´s proprietary antiviral against RSV, demonstrated a dose-dependent clinical efficacy, clearly reducing patients' signs and symptoms scores and, concomitantly, their viral loads; Ark was also able to demonstrate a clear correlation between the change in signs and symptoms score, viral load, and Ziresovir concentration. The drug retains its excellent safety profile.
Ark is currently launching a Ziresovir Phase III study in China, with an upcoming global Phase III study to follow. Ark currently also has Ziresovir under clinical study in adults infected with RSV. Commented Dr Jim Wu, "Ark is now the leader in RSV antiviral development, in a therapeutic area with a huge unmet medical need, but littered with failures"; Dr Stephen Toovey, Chief Medical Officer and co-Founder of Ark added, “Ark's RSV program is truly ground-breaking, representing a true medical first: the successful antiviral treatment of infant RSV disease."
Idiopathic Pulmonary Fibrosis (IPF) Program
Ark is currently developing its antifibrotic AK3280 for the stand-alone treatment of IPF. The molecule, which is expected to show superior safety, tolerability and efficacy, has successfully completed its first two clinical trials, confirming excellent safety and tolerability in man, without the typical troubling side effects seen with existing standard-of-care. A global Phase II IPF study is on track to commence later this year. Additional indications beyond IPF are being developed in parallel with additional Phase II studies to commence later this year.
Dr Jim Wu added, “Our progress reported with AK3280 expands Ark's existing portfolio, reflecting the company's focus on respiratory diseases and viral infections. Ark is a recognized developer of innovative respiratory medicines. We bring a unique focus to the development of AK3280 as the new standard-of-care for IPF, and other fibrotic diseases, both globally and in China.”
Commented Dr Stephen Toovey, “IPF is a progressive and fatal disease that robs victims of breath and life. Ark is committed to bringing this promising new treatment for IPF to patients, with the goal of offering a better treatment, and a better quality of life to IPF victims.”
“We are delighted to be presenting again at JPM conference this year,” said Dr Jim Wu, CEO of Ark Biosciences. "At Ark, our mission is to become a global leader of innovation in anti-viral, and respiratory diseases.”
Ziresovir, formerly known as AK0529, was discovered following the optimization of hits obtained screening a very large compound library against respiratory syncytial virus (RSV) replication in cell culture. Thereafter the drug completed rigorous preclinical and toxicological evaluation, including juvenile animal toxicology studies. Ziresovir is a structurally novel compound that binds to the viral 'F' or fusion protein of RSV, preventing entry of the virus into human cells and their infection, and thereby disease; this F-protein inhibition can also exert an anti-pathogenic action, preventing the cell-to-cell fusion (or "syncytium") that is a hallmark of RSV infection. Ziresovir’s mechanism of action is thus distinct from that of the common nucleoside class of antiviral drugs, which target and interfere with the production of nucleic acid within infected human cells, and reproduction, and is expected to be free of the nucleoside class safety issues.
About Respiratory Syncytial Virus
RSV is one of the most infectious human viruses, infecting 3-10% of the world’s population each year. It is the most common cause of acute lower respiratory disease in infants and children. It is a leading cause of death in children under 5 years of age, as well as being the leading cause of childhood lower respiratory tract infection (LRTI), bronchiolitis and infant hospitalization.
Globally there are 34 million cases of LRTI and up to two hundred thousand deaths in children under 5 years of age every year from RSV infection. Equally, RSV has been recognized as a cause of severe lung infection and death in older adults. Additional high-risk patient populations for RSV disease include the immunocompromised, as well as those with chronic lung conditions, congenital heart disease, and chronic obstructive pulmonary disease (COPD) e.g. chronic bronchitis and emphysema. There is no vaccine available to protect against RSV infection. Current therapy for those ill with RSV infection comprises solely symptomatic or supportive care.
AK3280 is an orally available, small, synthetic molecule. The molecule is being developed by Ark for the treatment of idiopathic pulmonary fibrosis (IPF) and potentially for other fibrotic diseases.
Preclinical data have demonstrated that AK3280 is a potent fibrosis inhibitor in animal models of pulmonary and hepatic fibrosis. AK3280 is based on the phenyl pyridone chemical scaffold of pirfenidone, a marketed anti-fibrotic and anti-inflammatory agent that has been shown to provide clinically meaningful benefit for patients with IPF. Pharmacokinetic (PK) data with AK3280 in animals and healthy volunteers, suggest that dosing once daily (QD) may be possible in patients with IPF, an improvement on the current standard of care. Also, based on preclinical data, and data generated in healthy volunteers summarized, there appears to be a potential for fewer adverse events (AEs) such as gastrointestinal (GI) effects, liver toxicity, and phototoxicity associated with the current standard of care.
About Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is an orphan disease that affects about 5 million people worldwide, including about 100,000 patients in US. It is an invariably fatal disease which progressively destroys lung tissue, replacing healthy lung with fibrotic scar like tissue. The cause is unknown, and the disease is considered incurable. Sufferers experience increasing shortness of breath, chronic cough, and ever decreasing effort tolerance; respiratory failure and death typically supervene within four years of the initial diagnosis.
About Ark Biosciences Inc.
Ark Biosciences is a privately held, clinical stage global biotechnology company with its corporate office located in Zhang Jiang Hi-Tech Park in Shanghai, its R&D Center in Suzhou BioBay, China, and offices in the United States, Australia and Switzerland. Ark Biosciences has its own active R&D programs and programs in collaboration with external partners. Through these efforts, Ark Biosciences aims to be a global biotechnology company, discovering and developing innovative drugs for treatment of viral infections and respiratory diseases. For more information, please visit: www.arkbiosciences.com