[ Back to EurekAlert! ] Public release date: 30-May-2013
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Contact: John Donovan
press@aliosbiopharma.com
650-635-5504
Alios BioPharma, Inc.

Alios BioPharma initiates Phase 1 clinical trial for respiratory syncytial virus infection

ALS-8176 is a first-in-class nucleoside analog targeting the RSV polymerase and has demonstrated potent antiviral activity against multiple RSV strains

SOUTH SAN FRANCISCO, CA– May 30, 2013 – Alios BioPharma, Inc. today announced that it has begun oral dosing of ALS-8176 in a Phase 1 clinical trial. ALS-8176 is a structurally novel, anti-respiratory syncytial virus (RSV) nucleoside analog that is being developed for the treatment of acute RSV infection. It is the only known nucleoside analog currently in clinical development for the treatment of RSV. ALS-8176 demonstrates potent anti-viral activity across multiple strains of RSV in preclinical studies and represents an important step forward in the development of more effective treatments for this serious and often life threatening disease.

The randomized, double-blind, placebo-controlled, Phase 1 study of orally administered ALS-8176 will evaluate safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses in healthy volunteers. The trial will assess several dose levels in up to 90 healthy adults.

ALS-8176 was discovered following the optimization of screening hits obtained through testing the Alios proprietary nucleoside analog library against replicating RSV in cell culture. The compound acts by blocking replication through a classic chain-termination mechanism and inhibits all RSV strains tested.

Due to their high barrier to viral resistance, nucleoside analogs have become the backbone of antiviral therapy in many clinical settings including the treatment of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and herpes simplex virus (HSV). More recently, emerging data suggest the pivotal role nucleoside analogs will play in the future treatment of chronic hepatitis C (HCV).

"Alios believes ALS-8176 has great potential to become an effective first-line antiviral therapy for RSV infection, a disease where few treatment options currently exist," said Lawrence M. Blatt, PhD, Chief Executive Officer. "The advancement of ALS-8176 for RSV, together with the recently reported positive clinical data with VX-135 (formerly ALS-2200, an anti-HCV nucleotide analog), demonstrates the broad capabilities of the Alios discovery platform. We are currently utilizing this platform to screen against several infectious diseases with high unmet medical needs."

Alios has built its drug discovery engine based on its core competencies in nucleoside synthetic chemistry, including prodrug chemistry, and a breadth and depth of virology expertise built over decades in the antiviral field. The Alios platform has been utilized to create a portfolio of antiviral drug candidates against multiple viruses including HCV, RSV, picornavirus (rhinovirus), and norovirus. In addition, the company is selectively pursuing non-nucleoside drug discovery in areas where combination regimens may be particularly useful.

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About RSV

Respiratory syncytial virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children. Almost all children are infected with RSV by age two, and half will have experienced at least two infections. Globally, RSV is responsible for up to 199,000 deaths per year in children under five years of age, primarily in the developing world1 and, in the United States, RSV infection results in the hospitalization every year of up to 125,000 children under one year of age.2 In adults, the virus may only produce symptoms of a common cold, such as a stuffy or runny nose, sore throat, mild headache, cough, fever, and a general feeling of being ill. However, severe RSV infections are common among elderly patients and immunocompromised populations.

About Alios BioPharma

Alios BioPharma, a privately held clinical stage biotechnology company located in South San Francisco, California, is developing novel medicines aimed at the treatment of viral diseases. In collaboration with Vertex Pharmaceuticals, Inc. (NASDAQ: VRTX), Alios is developing VX-135 (formerly ALS-2200), a uridine nucleotide analog, for the treatment of chronic hepatitis C. VX-135 entered Phase 2 clinical trials in early 2013. Alios has developed a novel proprietary nucleoside library to identify therapeutics for the treatment of several viral infections including RSV, picornavirus (rhinovirus), norovirus and other emerging viral diseases. Additionally, Alios is developing small molecule therapeutics that will complement its nucleoside portfolio. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability.

1 Nair H et al., Lancet. 2010 May 1; 375(9725): 1545-1555
2 http://www.cdc.gov/rsv/about/faq.html

Alios BioPharma contact:
John Donovan, 650-635-5504
Chief Business Officer
press@aliosbiopharma.com



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