Biotech Values

[DewDiligence]

IDIX 2010-2011 News Flow

[Updated for Citi webcast on 5/26/10.]


HCV

Jun 2010: Start drug-drug-interaction study of IDX184+IDX320 in healthy volunteers. (This is a prerequisite for running a phase-2a combination study in HCV patients.)

Mid 2010: Complete IDX184+SoC phase-2a study and IDX184 3-month animal tox. (These two tasks will enable IDX184 to proceed to phase-2b trials that test IDX184+SoC for 12 weeks and provide the first SVR data for IDX184.)

Mid 2010: Start IDX375 phase-1b monotherapy trial.

2H10: Start phase-2a all-oral trial of IDX184+IDX320 in HCV patients. (Positive results from the aforementioned DDI study are a prerequisite for starting the phase-2a trial; the phase-2a duration of treatment will be 14 or 28 days, depending on feedback from the FDA.)

Timing uncertain: Ink IDX184 and/or IDX320 partnerships. (See comments in #msg-49732533.)

Nov 2010/AASLD: Present full phase-2a dataset for IDX184+SoC.

2H10: Select lead NS5A compound. (Start phase-1 trial in 1H11.)


HIV

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

Late 2010: Start IDX899 phase-2b trial in second-line setting, testing IDX899+Truvada vs Intelence+Truvada.*

Early 2011: 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.