Replies to post #79106 on Biotech Values

[DewDiligence]

ANDS re proposed ANA598 phase-2 design:

Maybe they can argue the rash AE in 800mg QID is a Cmax effect. Doing 400BID may solve the problem.

Well, the rash presumably is a Cmax issue to some degree, but patients in the proposed trial have to get through a cumulative first-day load of 1600mg (given 800mg BID). There might be some rash-induced some dropouts on the first day.

The proposed trial has failure written all over it, IMO. Let’s recap the unusual trial-design features which suggest to me that ANA598 has a narrow therapeutic index:

• The very high first-day loading dose of 1600mg, which is intended to allow an immediate reduction to 200mg BID on the second day.

• The unspecified “clinician’s discretion” duration of SoC treatment following the 12 weeks of triple therapy.

• The fact that no patients will be enrolled into the 400mg BID arm until all patients in the 200mg arm have been evaluated for 28 days.

If ANA598 ends up making it to phase-3 based on the proposed design for phase-2, I’ll eat my hat.