Biotech Values

[DewDiligence]

IDIX: Based on data from the full 20-patient cohort of IDX184 at 50mg qD (16 patients on IDX184, 4 on control), which were reported for the first time yesterday, it appears that 50mg qD is too low a dose. Fortunately, IDIX184 to date has had a squeaky-clean safety profile, so raising the dose ought not to be a problem. On yesterday's CC, Doug Mayers stated that the next dosing cohort, 100mg qD, has almost completed dosing without any AE’s, so it looks like IDIX will be able to go higher than 100mg/day if need be.

The planned cohorts in this trial are:

• 50mg qD (16 on IDX184, 4 on control): dosing completed; data reported.
• 100mg qD (8 on IDX184, 2 on control): dosing almost completed; no AE’s found.
• 150mg qD (16 on IDX184, 4 on control): not yet started.
• 200mg qD (8 on IDX184, 2 on control): not yet started.
• 100mg BID (8 on IDX184, 2 on control): not yet started.
• 200mg BID (8 on IDX184, 2 on control): not yet started.

My expectation is that an IDX184 partnership is not imminent, but rather will come after IDIX has completed more (or perhaps all) of the above cohorts. All of the above cohorts should be completed by midyear and the 3-month animal-tox study will be done by then, allowing IDIX (and partner) to embark on a 12-week trial of SoC ± IDX184.