Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

Dr. Jorgensen's excellent presentation is worth a listen or two.

http://eccmidlive.org/resources/a-randomized-double-blind-study-comparing-single-dose-and-short-course-brilacidin-to-daptomycin-in-the-treatment-of-acute-bacterial-skin-skin-structure-infections-absssi--2

Some notes and thoughts:

(1) Dr. Jorgensen notes the Brilacidin OM is "now in Phase 2 for prevention and treatment of oral mucositis." I don't think he misspoke.

(2) PK/PD modeling successfully predicted single dose effectiveness and shows slightly increasing efficacy predictions as the dose increases from 0.6-1.0 mg/kg. Base on the clinical data and the modeling data, I wonder if Cellceutix is considering bumping the dose slightly, perhaps to 0.7 mg/kg to maximize treatment dose while still limiting not so horrible side effects.

(3) Hypertension in Phase 2a was defined as SBP>180 while in Phase 2B the cutoff was SBP>160. 0.6 mg/kg dose had 3.8% of study patients with SBP>160, 0.8 mg/kg had 17% >160, and the 3 day regimen had 26% > 160. Daptomycin had 10%> 160. I don't know if these BPs reflect a change in BP during the one hour infusion (to >160)or if these patients started high or both. Many, many patients present with SBP in the neighborhood of 140-160 (or higher) so it doesn't sound like a big deal. It's also easily managed in an acute care setting. FWIW, one reported rate for hypertension with daptomycin dosing is 6.77%.

(4) Gender differences were not mentioned and I'm interpreting that as they are not significant in a way that will impact Phase 3 trial design. Curious as to how the found its way into van Bambeke's presentation. Obviously, I don't have all the information but I think it's a reasonable guess.