Alios BioPharma Reports Significant Progress With Its Clinical Program for AL-8176, Its Nucleoside Analog for the Treatment of
Respiratory Syncytial Virus (RSV)
Alios Initiating Human Viral Challenge Phase 2a Trial Following Phase
I Safety Study
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 01/13/14 -- Alios
BioPharma, Inc. today announced it is initiating a Phase 2a study
designed to evaluate the safety, pharmacokinetics and antiviral
activity of multiple doses of AL-8176 against respiratory syncytial
virus (RSV) infection in a virus challenge model. This clinical trial
follows the successful completion of a Phase I clinical trial for
AL-8176, its orally delivered, structurally novel anti-RSV nucleoside
analog being developed as a treatment for RSV in infants.
John DeVincenzo, MD, Professor of Pediatrics at the University of
Tennessee School of Medicine commented, "There is an enormous need
for new medications to treat the millions of infants and young
children infected with RSV and the Alios anti-RSV clinical program is
an important step towards providing a potential new treatment."
"Alios believes AL-8176 has potential to become an effective
first-line antiviral therapy for RSV infection in infants, a disease
where no treatment options currently exist," said Lawrence M. Blatt,
PhD, Chief Executive Officer. "The advancement of AL-8176 for RSV
into a Phase 2a viral challenge study demonstrates the broad
capabilities of the Alios discovery platform. We are currently
utilizing this platform to screen against several other respiratory
diseases with high unmet medical needs."
Top-Line Results of AL-8176 Phase 1 Study
The safety and PK of
AL-8176 was evaluated as single and multiple ascending oral doses in
a Phase 1 study in adult healthy volunteers (Study AL-8176-501). A
total of 100 healthy volunteers were enrolled and received single
doses and multiple doses of AL-8176 or placebo for up to 14 days.
AL-8176 was well tolerated in this study, with no serious adverse
events being reported and no adverse events leading to
About the AL-8176 Phase 2a Study
AL-8176-502 is a randomized,
double-blind, placebo-controlled Phase 2a study designed to evaluate
the safety, pharmacokinetics and antiviral activity of multiple doses
of AL-8176 against RSV infection in a virus challenge model.
Approximately 66 healthy volunteers will be enrolled and inoculated
with RSV, and subsequently given multiple doses of AL-8176 or placebo
for five days. This study is expected to be completed by mid-year
2014. The human challenge model has been successfully used to
evaluate proof-of-concept for antiviral agents and enable more rapid
advancement of investigational agents to Phase 2b and beyond.
AL-8176 is a nucleoside analog which is being
developed by Alios BioPharma as an orally administered antiviral
therapy for the treatment of infants infected with RSV. AL-8176 is
designed to inhibit the replication of the RSV by acting on the viral
polymerase. In vitro studies of the compound showed potent and highly
selective inhibition of both RSV laboratory-adapted A and B strains
as well as a range of diverse clinical isolates. In addition,
administration of AL-8176 resulted in potent multi-log suppression of
RSV in an in vivo preclinical model.
RSV is the leading cause of lower respiratory disease in
infants (Nair et al. 2010). In 2005, an estimated 33.8 million
episodes of RSV infection occurred worldwide in infants and young
children with most of these occurring in otherwise healthy full term
infants. Of these, at least 3.4 million severe cases of lower
respiratory tract infection (LRI) required hospitalization, and an
estimated 66,000 to 199,000 deaths occurred, mostly in the developing
world (Nair et al. 2010). In the United States, RSV infects at least
68% of the birth cohort each year (Shay et al. 1999, Glezen et al.
1986). By the second year in life, most children have been exposed to
RSV (Hall et al. 2001). Results of a prospective, population-based
inpatient and outpatient surveillance for acute respiratory
infections in children younger than 5 years suggest that
approximately 2.1 million children under 5 in the United States
require medical attention for RSV each year (Hall et al. 2009).
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
respiratory viral diseases. Alios has developed a novel proprietary
nucleoside library to identify therapeutics for the treatment of
several viral infections including RSV, rhinovirus, influenza and
other emerging respiratory 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. In collaboration with Vertex Pharmaceuticals, Inc.
(NASDAQ: VRTX), Alios is developing VX-135, a uridine nucleotide
analog for the treatment of chronic hepatitis C. VX-135 is in Phase 2
Alios BioPharma contact:
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