Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Galera's presentation data at Vienna was somewhat confusing. For example: their swimlanes do show 35 SOM incidences for 76 subjects (ITT) in 90 mg group, but they report percentage of ITT (43%) that gives 33 incidences, while swimlanes for placebo show 45 SOM incidences for 74 subjects (ITT) while they report percentage of ITT that gives 48 incidences.

Both deviations from swimlanes make GC4419 (lower SOM rate for GC4419, higher for placebo) look better and the opposite directions of 'deviations' make reasonable explanations hard to come by. BUT, probably just coincidences, or something like that, because, as SS says, Galera is a real company. Real companies do not fudge their data.

If you use swimlane data then GC4419's SOM incidence rate would be 61 % - compare that to 60 % reported by IPIX. SOM incidence rate for 90 mg GC4419 would be 46 %. IPIX reported SOM incidence rate for brilacidin to be 43 % in 21 subjects.

If you use swimlane data to construct Kaplan-Meier estimates for GC4419 90 mg and placebo you get this:
A. curves for placebo arm in Galera and IPIX trials are virtually identical with Log-Rank hazard ratio 1.01 (calculated IPIX trial over Galera).
B. Curves for Brilacidin and GC4419 90 mg are near identical and Log-Rank hazard ratio favors Brilacidin just so slightly, HR ~ 0.95.

Conclusion: So far no evidence for superiority of either drug.