Biotech Values

[DewDiligence]

IDIX 2010-2011 News Flow

[Revised schedule for start of IDX899 (HIV) phase-2b trials.]


HCV

Oct 2010/AASLD: Present complete datasets from IDX184, IDX320, and IDX375 studies for which top-line data was reported in IDIX’s 9/7/10 PR (#msg-54120531).

4Q10: Start IDX375 phase-1b 3-day monotherapy trial.

Late 2010/early 2011: Possible lifting of clinical hold on IDX184 and/or IDX320 programs following FDA review of combination animal-tox study and all clinical data to date.

Late 2010: Select lead NS5A compound. Start phase-1 trial in 1H11.


HIV

Late 2010: Start IDX899 phase-2b trial in second-line setting, testing IDX899+Truvada vs Intelence+Truvada.* (IDIX will receive a sizable milestone payment from GSK when the first patient is dosed in a phase-2b study—see #msg-49743057.)

Early 2011: Start IDX899 phase-2b trial in first-line setting, testing IDX899+Truvada vs Sustiva+Truvada.*

1H11: Start IDX899 phase-2b “nuke sparing” trial, testing IDX899 + GSK1349572 (GSK’s integrase inhibitor) vs a comparator to be determined.* (The DDI study described in #msg-48915175 is a prerequisite for starting this trial.)

*These trials will be conducted by IDIX’s partner, GSK (d/b/a ViiV Healthcare).