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Re: DewDiligence post# 90294

Friday, 02/26/2010 4:12:59 AM

Friday, February 26, 2010 4:12:59 AM

Post# of 257257
IDIX 2010 Possible/Probable News Flow

[Updated for 4Q09 CC on 2/25/10; the main change is that I’ve listed the IDX184 partnership signing as a midyear rather than 1H10 event.]


HCV

Apr 2010 at EASL: Report IDX184 phase-2a data from the 100mg qD cohort. (Full data from the 50mg qD cohort were reported on the 4Q09 CC, and it appears that 50mg qD is too low a dose: #msg-47110029.)

Apr 2010 at EASL: Report additional phase-1 data for IDX375. (Interim data were reported at the JPM conference on 1/11/10: #msg-45350536.)

Mid 2010: Complete all dosing cohorts of IDX184 phase-2a trial.

Mid 2010: Complete 3-month animal-tox study of IDX184.

Timing uncertain (likely around midyear, IMO): Ink IDX184 partnership. (See #msg-47110029 for musings on the partnership timing.)

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

Mid 2010: Start phase-1b monotherapy trial for IDX320.

Nov 2010 at AASLD: Present complete phase-2a data for IDX184.

2H10: Start phase-2b trial of IDX184 (after inking partnership deal).

2H10: Select lead compound from NS5A program. Start phase-1 trial in 1H11.


HIV

Mar 2010: GSK* completes IDX899 PK/food study testing multiple formulations at 100mg qD (#msg-44790049).

2Q10: Start phase-2b trials for IDX899 in treatment-naïve and treatment-experienced settings using the preferred 100mg formulation from the PK/food study.

*GSK is the operator of ViiV Healthcare, the joint venture with PFE that is the licensee of IDX899 (#msg-43254006).


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