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April 28, 2015 7:24 AM ET

Biotechnology

Company Overview of Alios BioPharma, Inc.

Company Overview

Alios BioPharma, Inc. operates as a biotechnology company that develops novel antiviral therapies for the treatment of respiratory diseases in patients worldwide. The company develops AL-8176, an anti-respiratory syncytial virus (RSV) nucleoside analog for the treatment of RSV; AL-335, a potent uridine based nucleotide analog; and AL-516, a potent guanosine based nucleotide analog. It offers its therapeutics for viral infections, including influenza, rhinovirus, coronavirus, and hepatitis C. The company was incorporated in 2006 and is based in South San Francisco, California. As of November 7, 2014, Alios BioPharma, Inc. operates as a subsidiary of Janssen Pharmaceuticals, Inc.

260 East Grand Avenue

South San Francisco, CA 94080

United States

Founded in 2006

Phone:

650-635-5500

Fax:

650-872-0584

Key Executives for Alios BioPharma, Inc.

Founder, Chief Executive Officer, President and Director
Age: 52
Founder and Chief Scientific Officer
Founder and Chief Business Officer
Senior Director of Operations and Project Management
Vice President of Drug Discovery
Age: 47
Compensation as of Fiscal Year 2014.

Alios BioPharma, Inc. Key Developments

Alios Biopharma, Inc. to Present Preclinical Data on its Anti HCV Nucleotides Al 335 and Al 516

Alios BioPharma, Inc. announced the upcoming presentation of preclinical data from two of its anti-hepatitis C virus (HCV) nucleotide analogs at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) beginning in Boston. Data from two novel compounds AL-335, a potent uridine based nucleotide analog and AL-516, a potent guanosine based nucleotide analog will be presented in two poster sessions on November 11. AL-335 is a monophosphate prodrug of a uridine-based nucleotide analog and has been identified as a potent inhibitor of NS5B-directed HCV RNA replication. Results presented previously have shown that AL-335 demonstrates potent inhibition of HCV in the cell-based replicon assay across genotypes. In this most recent study, AL-335 was examined in pairwise combinations with multiple classes of compounds either approved for the treatment of chronic hepatitis C (CHC) or currently in clinical development. The classes of compounds tested included NS3/4A protease inhibitors, NS5A inhibitors, nucleoside/tide and non-nucleoside polymerase inhibitors, cyclophilin A inhibitors, type I and type III interferons (IFNs) and ribavirin (RBV). All of the combinations were either additive or synergistic in vitro, and no antagonistic effects were observed. The combination of AL-335 with the NS3/4A inhibitor simeprevir (Olysio) demonstrated a high level of synergy. AL-516, the guanosine-based nucleotide analog, was evaluated using the HCV replicon system encoding NS5B sequences from multiple genotypes and resistant variants and was profiled for its effects on cell viability and mitochondrial toxicity. The nucleoside 5'-triphosphate (AL-516 NTP) was tested against the HCV polymerase NS5B and for selectivity against human DNA and RNA polymerases. In the stable genotype (GT) 1b replicon assay, AL-516 exhibited potent antiviral activity with an EC(sub)50(/sub) of 7 nM. In transient chimeric GT-1b replicons with NS5B regions derived from GT 1-4, AL-516 demonstrated pan-genotypic activity with EC(sub)50(/sub) values (10 nM. AL-516 retained activity versus replicon mutants resistant to other nucleoside inhibitors. AL-516 exhibited an excellent selectivity profile with no inhibition of mitochondrial protein synthesis (IC(sub) 50(/sub))100 ÎM).

Alios BioPharma, Inc. Reports Positive Results of its Anti-RSV Nucleoside Analog AL-8176 in a Phase 2 Challenge Study in Adults Infected With Respiratory Syncytial Virus

Alios BioPharma, Inc. announced positive results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176. The study was conducted in healthy adult volunteers who were infected intranasally with respiratory syncytial virus (RSV). AL-8176 achieved its primary and secondary endpoints of reduction in viral load (p < 0.0002) and improvement in symptom scores (p < 0.02) as compared to placebo. AL-8176 was well tolerated with no discontinuations of study drug and no clinically significant laboratory abnormalities. The Alios study enrolled 62 healthy adults who received one of three dose regimens of AL-8176 or placebo over 5 days: 375 mg orally administered twice daily or 750 mg given as a single loading dose followed by twice daily maintenance doses of 150 mg or 500 mg. Administration of AL-8176 began approximately 12 hours after confirmation of RSV infection as determined by presence of RSV RNA in nasopharyngeal washes. In successfully infected subjects, marked immediate reduction in RSV viral load was observed following treatment in all three AL-8176 treated dose groups as compared to placebo where subjects exhibited a logarithmic increase in RSV RNA with a peak viral load at day 3.5 following start of dosing. At discharge (day 12), all subjects treated with AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable on follow-up on days 16 and 28. This is in contrast to placebo treated subjects who had a mean RSV RNA of 0.52 log(10) plaque forming unit equivalents (PFUe) /mL on the day of discharge. The viral load reduction in infected subjects across all dosing regimens was associated with concomitant improvements in RSV symptom scores and reductions in mucus weight.

Alios BioPharma, Inc. Reports Significant Progress with its Clinical Program for AL-8176, its Nucleoside Analog for the Treatment of Respiratory Syncytial Virus

Alios BioPharma, Inc. 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. 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. About AL-8176: 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. About RSV: 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.

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