[Updated for clinical hold on IDX184 and IDX320 programs and release of data in today’s PR on the IDX184, IDX320, and IDX375 programs; removed entry for IDX184 and/or IDX320 partnerships insofar as this must now await the lifting of clinical hold.]
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).
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
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.
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