08/01/2020 8:00:00 AM CST Shanghai

Ark to Showcase Anti-Viral and Respiratory Pipeline

Ark Biosciences, a global biotech company developing groundbreaking therapeutics for viral infection and respiratory diseases, today announced its participation in and presentation at the JP Morgan Healthcare Conference on January 15th 2020 at the Westin St. Francis Hotel, San Francisco. Dr. Jim Wu, Founder & CEO, will be presenting at the JP Morgan Healthcare Conference as below:

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 going to launch 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 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.”. 

About Ziresovir

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 the most significant viral pathogen globally causing acute lower respiratory tract infections in children under 5 years old. It is also the primary cause of hospitalization for infant virus-related respiratory infections. In recent years, mounting research has demonstrated that RSV also plays a pivotal role in severe lung diseases in adults, primarily the elderly. It is estimated that in 2019, there were approximately 33 million cases of RSV-ALRTI (RSV viral infection with symptoms of acute lower respiratory tract infection) in children under 5 years old worldwide, which resulted in approximately 3.6 million hospitalizations and 100,000 deaths. Currently, there are no effective treatments specifically for RSV.

About AK3280

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

IPF is a special manifestation of idiopathic interstitial pneumonia, which is a chronic progressive fibrotic lung disease of unknown etiology. In May 2018, it was included in "the first batch of rare disease list of China". The global incidence of IPF is estimated to increase from 1.4 million in 2015 to 1.7 million by 2022.  IPF patients have a median survival time of only 3-5 years, with a five-year survival rate estimated to be around 20%, even lower than many types of cancer.

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