Biotech Values

[DewDiligence]

IDIX 2010-2011 News Flow

[Updated for disclosures on 2Q10 CC and other recent webcasts.]


HCV

Sep 2010: Press release with top-line data from three studies: i) IDX184+IDX320 drug-drug-interaction study in healthy volunteers (#msg-52028450); ii) all cohorts of 2-week phase-2a study of IDX184+SoC; and iii) all cohorts (38 patients in all) of IDX320 phase-1b 3-day monotherapy study. Full datasets from these three studies will be presented at AASLD—see below.

Oct 2010/AASLD: Present full datasets from the three studies mentioned in Sep 2010 entry above.

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

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

4Q10: Start phase-2a all-oral trial of IDX184+IDX320 in HCV patients. (Satisfactory data from the aforementioned DDI study in healthy volunteers are a prerequisite.) The design will be similar to Roche’s INFORM-1 study: 4 weeks of all-oral treatment followed by SoC.

4Q10: Start 12-week phase-2b trial of IDIX184+SoC. (Three-month animal tox for IDX184, a prerequisite for conducting this trial, will be completed in 3Q10.)

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


HIV

Sep 2010/ICAAC: Three poster presentations for IDX899.

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—see #msg-49743057.)

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