[I changed the timing of the start of the IDX184+IDX320 DDI study (the first item below) from June to Jul/Aug, based on the wording of today’s PR in #msg-51127676. Although the DDI study is in healthy volunteers and it theoretically could be conducted in parallel with the phase-1b trial of IDX320 in HCV patients, IDIX will apparently wait until it has data from at least some of the cohorts in the phase-1b trial before asking the FDA to sign off on the DDI study.]
HCV
Jul/Aug 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.)
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.
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