Anybody following this HBV play for 2015
. (TLOG) - Pharmaceuticals Corp. (TLOG) - Buy, PT $16.00
HBV Program Update at AASLD; Reiterate Buy Rating
Company Update
INVESTMENT HIGHLIGHTS: This morning at the American Association for the Study of Liver Disease (AASLD) meeting, TetraLogic presented new preclinical data supporting the development of birinapant in hepatitis B (HBV). The company announced the initiation of a Phase Ib/IIa study in chronically infected HBV patients. We expect data mid next year. Given the demonstrated safety profile of birinapant and the strong preclinical data and rationale for treating HBV, we are optimistic that we could see not only viral load reductions but also reduction in surface antigen and even seroconversion which is not achievable with direct antivirals.
Update on Birinapant in Infectious Disease. TetraLogic hosted an investor forum with Dr. Marc Pellegrini of the Walter & Eliza Hall Institute in Australia who has conducted preclinical efficacy and mechanism of actions studies of birinapant vs entecavir in mouse models of HBV infection. Dr. Pellegrini reported significant reduction in viral load in infected mice treated with 10 and 30 mg/kg of birinapant along with decreases in surface antigen. While viral load reduction was seen with entecavir, surface antigen reduction was not seen. As a reminder, the surface antigen decreases are significant because they represent reductions in the latent reservoirs of the disease which are not reduced by current antivirals such as entecavir. Additionally, viral load reduction was more effective in models that received birinapant and entecavir. The most encouraging data was that the mice seroconverted by developed antigens to HBV in as little as 2 weeks, while sparing healthy liver cells. We believe that this preclinical data is exciting and presents a new mechanism of treating HBV. TetraLogic initiated a placebo-controlled, dose-escalating Phase Ib/IIa study in 48 chronically infected HBV patients in Australia and New Zealand already being treated with tenofovir or entecavir today. The study will look for reductions in surface antigen in patients out to 85 days, safety and tolerability, and PK. Patients will be assigned to 1 of 6 dosing cohorts, and those assigned to a birinapant dose will be given a dose weekly for 4 weeks. Topline data is expected to be released mid-‘15.iterate Buy Rating
Company Update
INVESTMENT HIGHLIGHTS: This morning at the American Association for the Study of Liver Disease (AASLD) meeting, TetraLogic presented new preclinical data supporting the development of birinapant in hepatitis B (HBV). The company announced the initiation of a Phase Ib/IIa study in chronically infected HBV patients. We expect data mid next year. Given the demonstrated safety profile of birinapant and the strong preclinical data and rationale for treating HBV, we are optimistic that we could see not only viral load reductions but also reduction in surface antigen and even seroconversion which is not achievable with direct antivirals.
Update on Birinapant in Infectious Disease. TetraLogic hosted an investor forum with Dr. Marc Pellegrini of the Walter & Eliza Hall Institute in Australia who has conducted preclinical efficacy and mechanism of actions studies of birinapant vs entecavir in mouse models of HBV infection. Dr. Pellegrini reported significant reduction in viral load in infected mice treated with 10 and 30 mg/kg of birinapant along with decreases in surface antigen. While viral load reduction was seen with entecavir, surface antigen reduction was not seen. As a reminder, the surface antigen decreases are significant because they represent reductions in the latent reservoirs of the disease which are not reduced by current antivirals such as entecavir. Additionally, viral load reduction was more effective in models that received birinapant and entecavir. The most encouraging data was that the mice seroconverted by developed antigens to HBV in as little as 2 weeks, while sparing healthy liver cells. We believe that this preclinical data is exciting and presents a new mechanism of treating HBV. TetraLogic initiated a placebo-controlled, dose-escalating Phase Ib/IIa study in 48 chronically infected HBV patients in Australia and New Zealand already being treated with tenofovir or entecavir today. The study will look for reductions in surface antigen in patients out to 85 days, safety and tolerability, and PK. Patients will be assigned to 1 of 6 dosing cohorts, and those assigned to a birinapant dose will be given a dose weekly for 4 weeks. Topline data is expected to be released mid-‘15.
