Biotech Values

[DewDiligence]

IDX184 Phase-2a Final Results from 50mg qD Cohort

This post is an adjunct to #msg-47110029 and should be read in
conjunction with it. The source of the numbers in the table below
is IDIX’s 4Q09 CC held on 2/25/10. Although the number of patients
is small and the dosing regimen was suboptimal (see footnote*), I
think these results show that 50mg qD is probably too low a dose.
Fortunately, IDX184 to date has had a squeaky-clean safety profile
and raising the dose as planned ought not to be a problem.

  
                        Mean Log    Stddev Log    # of         % of 
                        Reduction   Reduction   Patients     Patients 
                # of    Viral Load  Viral Load  Undetctable  Undetctable  
              Patients  (14 Days)   (14 days)   (28 days)    (28 days) 
 IDX184+SoC*    16         2.7         1.3          3†          19%* 
 SoC alone       4         1.9         1.1          0            0%

*Patients in this arm were given IDX184+SoC for 14 days, followed by 14 days of SoC alone; thus, the 19% figure is not an RVR rate for the triple therapy. The 14-day limit for IDX184 dosing in the phase-2a trial has been imposed because 14 days is the duration of the completed animal-tox studies; optimal IDX184 treatment regimens will include a longer duration of IDX184+SoC (or IDX184 + other DAA’s).

†Two patients went undetectable during the 14 days of IDX184+SoC treatment and one patient went undetectable after 21 days (14 days of IDX184+SoC and 7 days of SoC alone).