SOUTH SAN FRANCISCO, CA--(Marketwired - January 13, 2014) - 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 discontinuation.
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 clinical trials.