New Data Published in the New England Journal of Medicine Shows Potential of Compound to Fight RSV Infection in Adults and Children

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SAN FRANCISCO, Nov. 19 /PRNewswire=KYODO JBN/ --

- ALS-008176 now being evaluated in RSV-infected infants -

Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies announced

that the New England Journal of Medicine (NEJM) will publish findings from a

respiratory syncytial virus (RSV) challenge study for ALS-008176, a cytidine

nucleoside analog with activity against RSV.[1] Among infants and young

children, RSV is the leading cause of severe respiratory illness and remains

the most frequent cause of hospitalization in industrialized countries.[2] This

Phase 2a study has now established human proof-of-concept for the antiviral

activity of ALS-008176 in healthy adults and highlights its potential as a

therapy for managing clinical disease in naturally infected patients.[1]

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"The data suggest that ALS-008176 has the potential to be a safe and effective

treatment for RSV infection. The primary endpoint of the study was met and

ALS-008176 significantly reduced viral load and symptoms of disease severity

compared to placebo," said John DeVincenzo, M.D., the lead study author and

Professor of Pediatrics, and Professor of Microbiology, Immunology and

Biochemistry at the University of Tennessee Health Science Center, and Medical

Director of Molecular and Viral Diagnostics at Le Bonheur Children's Hospital.

"ALS-008176 can inhibit the replication of RSV even if the cells of the

respiratory tract have already been infected with the virus. As a result, this

treatment has an antiviral effect and is likely to be effective even if started

at a later stage of RSV infection."

In this randomized, double-blind study, 62 healthy volunteers were inoculated

with RSV and subsequently randomized to receive ALS-008176 or placebo. Compared

to placebo, treatment with ALS-00876 resulted in a significant reduction of

viral load (73-88% reduction in viral load area under the curve) and faster

viral clearance (1.3-2.3 days vs 7.2 days) versus placebo. At the time that the

peak viral load occurred in the placebo group, the mean viral load in each of

the three ALS-007186 treatment groups was more than one thousand times lower.

In addition, statistically significant reductions in symptom scores and a

reduction of the amount of congesting respiratory secretions were also

observed.[1]

In the study, no serious adverse events (SAEs), premature discontinuations of

study drug, or clinically significant treatment related adverse events (AEs)

were observed. The most commonly reported AEs were epistaxis (bleeding from the

nose), upper respiratory infection and cough. AEs were generally balanced in

terms of frequency and intensity across recipients of ALS-008176 and placebo.

ALS-008176 also demonstrated a high barrier to resistance. No participants

receiving ALS-008176 experienced viral rebound or had evidence of viral

resistance during the course of the study.[1]

RSV is a seasonal virus that affects the lungs and airways for which there is

currently no vaccine and no guideline-recommended antiviral treatment options

available. RSV can be partially prevented by a monoclonal antibody, but its use

is limited to a small fraction of premature infants or infants with uncommon

heart or lung problems.[2],[3] Each year, there are approximately 64 million

cases of RSV infection among adults and children and nearly 100% of infants

will have at least one RSV infection by their second year of life.[4] In a

single year (2005), around 33.8 million infants and young children had RSV

infections in the lower respiratory tract and at least 3.4 million were

hospitalized. This was associated with between 66,000 and 199,000 deaths.[5]

"Janssen is currently working on the discovery and development of multiple

treatment and vaccine candidates against RSV infection," said Lawrence M.

Blatt, PhD, Global Therapeutic Area Head Infectious Diseases and Vaccines,

Janssen Research & Development, LLC. "The data published in the New England

Journal of Medicine highlight the potential this new compound has to

effectively treat patients suffering from severe RSV infection. It underscores

our commitment to develop highly innovative healthcare solutions in areas of

great unmet need."

ALS-008176 is an orally bioavailable prodrug of the RSV replication inhibitor

ALS-008112, a cytidine nucleoside analog. It is designed to inhibit the

replication of RSV by acting on the viral polymerase and is currently being

evaluated in hospitalized RSV-infected infants.  

About the Janssen Pharmaceutical Companies  

At Janssen, we are dedicated to addressing and solving some of the most

important unmet medical needs of our time in oncology, immunology,

neuroscience, infectious diseases and vaccines, and cardiovascular and

metabolic diseases. Driven by our commitment to patients, we develop innovative

products, services and healthcare solutions to help people throughout the

world. Alios BioPharma Inc., and Janssen Research & Development, LCC are part

of the Janssen Pharmaceutical Companies. Please visit http://www.janssen.com

for more information.

About Janssen's Development Programs in Respiratory Diseases

Janssen is dedicated to the ongoing research and development of innovative

solutions which will help to prevent and treat severe respiratory infections

including influenza and human respiratory syncytial virus (RSV), with the goal

of reducing worldwide burden.  Janssen is currently working on the discovery

and development of multiple treatment and vaccine candidates against influenza

and RSV.  

Within RSV, our development program includes the cytidine nucleoside analog

inhibitor ALS-008176. This compound is currently being evaluated in clinical

studies in the hospital setting. We also have an investigational fusion

inhibitor which is currently undergoing a Phase 2a human challenge study and an

RSV vaccine candidate Ad35.RSV.FA2 which has entered a Phase 1 study in the U.S

to evaluate the safety, tolerability and immunogenicity in healthy adults.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the

Private Securities Litigation Reform Act of 1995 regarding product development.

The reader is cautioned not to rely on these forward-looking statements. These

statements are based on current expectations of future events. If underlying

assumptions prove inaccurate or known or unknown risks or uncertainties

materialize, actual results could vary materially from the expectations and

projections of Alios BioPharma, Inc. and/or Johnson & Johnson. Risks and

uncertainties include, but are not limited to: challenges and uncertainties

inherent in new product development, including uncertainty of clinical success

and obtaining regulatory approvals; competition, including technological

advances, new products and patents attained by competitors; challenges to

patents; changes to applicable laws and regulations, including global health

care reforms; and trends toward health care cost containment. A further list

and description of these risks, uncertainties and other factors can be found in

Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended

December 28, 2014, including in Exhibit 99 thereto, and the company's

subsequent filings with the Securities and Exchange Commission. Copies of these

filings are available online at http://www.sec.gov, http://www.jnj.com or on

request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or

Johnson & Johnson undertakes to update any forward-looking statement as a

result of new information or future events or developments.

1. DeVincenzo JP, et al. Activity of Oral ALS-008176 in a Respiratory Syncytial

Virus Challenge Study. New England Journal of Medicine. 19 November 2015.

2. American Academy of Pediatrics Committee on Infectious Diseases, American

Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for

palivizumab prophylaxis among infants and young children at increased risk of

hospitalization for respiratory syncytial virus infection. Pediatrics

2014;134:415-20.

3. Centers for Disease Control and Prevention. Respiratory Syncytial Virus

Infection (RSV): For Healthcare Professionals [Online]. Available

at:http://www.cdc.gov/rsv/clinical/ Last accessed October 2015.

4. World Health Organization. Initiative for Vaccine Research: Acute

Respiratory Infections [Online]. Available at:

http://apps.who.int/vaccine_research/diseases/ari/en/index2.html Last accessed

October 2015.

5. Nair H, et al. Global burden of acute lower respiratory infections due to

respiratory syncytial virus in young children: a systematic review and

meta-analysis. Lancet. 2010;375:1545-55.

SOURCE: Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies