Biotech Values

[DewDiligence]

IDIX 2010-2011 News Flow

[Updated info for IDX184+IDX320 DDI study.]


HCV

Jul 2010: Dose first subject in drug-drug-interaction study of IDX184+IDX320 in healthy volunteers. This DDI study, which is a prerequisite for running a phase-2a combination study in HCV patients, now has a listing in clinicaltrials.gov (#msg-52028450).

Aug 2010: Complete above DDI study and report go/no-go decision as to whether IDIX can proceed to an all-oral phase-2a study of IDX184+IDX320 in HCV patients.

3Q10: 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.)

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

4Q10: 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.