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November 29, 2015 10:45 PM ET


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





Key Executives for Alios BioPharma, Inc.

Founder, Chief Executive Officer, President and Director
Age: 53
Founder and Chief Scientific Officer
Founder and Chief Business Officer
Senior Director of Operations and Project Management
Vice President of Drug Discovery
Age: 48
Compensation as of Fiscal Year 2015.

Alios BioPharma, Inc. Key Developments

Alios Biopharma Inc. Starts Phase IIa Study to Evaluate the Effect of Simeprevir in Combination with Odalasvir and AL-335

Medivir AB announced that Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies has started a phase IIa clinical trial to evaluate the combination of simeprevir, odalasvir (also known as ACH-3102), and AL-335 in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. This phase IIa study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms. Approximately 150 million people are chronically infected with HCV globally. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However, combinations of direct acting antiviral agents, including treatment regimens containing a protease inhibitor such as simeprevir, have shown the potential to be curative and convenient regimens for patients infected with HCV.

JAlios Biopharma Inc. Initiates Phase I Study to Evaluate the Effect of Simeprevir and Odalasvir (ACH-3102) on AL-335 Pharmacokinetics

Alios Biopharma Inc. has initiated a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102) on the pharmacokinetics of AL-335 in healthy volunteers. This phase I study is an open-label, two-group study of simeprevir and odalasvir, a HCV NS5A inhibitor, on the pharmacokinetics of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective of the study is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers. As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion’s HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.

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).

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