Alios BioPharma Initiates Phase 1 Clinical Trial for Respiratory Syncytial
Virus (RSV) Infection
ALS-8176 Is a First-in-Class Nucleoside Analog Targeting the RSV
Polymerase and Has Demonstrated Potent Antiviral Activity Against
Multiple RSV Strains; Third Compound Advanced to Clinical Trials in
the Last 18 Months Discovered Using the Alios Proprietary Nucleoside
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 05/30/13 -- 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
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
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
world(1) 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
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
Alios BioPharma contact:
Chief Business Officer
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