Replies to post #321698 on Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

The numbness and tingling was addressed by Cellceutix and was not felt to be clinically relevant. Below are their comments


"All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator".

http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin

•Phase 1 studies completed•Ascending single-dose (PMX63-101), multiple-dose x 5 days (PMX63-102), and fixed-dose x 14 days (PMX63-103)•IV infusions q48H, q24H, and q12H•Pharmacokinetics•Consistent and linear pharmacokinetics in plasma with half-life of ~ 15-23 hours. •Ex-vivo efficacy•Long lasting bactericidal and inhibitory activity vs. MSSA and MRSA in serum from human subjects after doses as low as 0.1 mg/kg •Safety•Mild paraesthesiaand hypoaesthesia(numbness and tingling) with acute onset and rapid resolution No neurotoxicity evident in human subjects or animal safety studies•Transient blood pressure elevation •Dose-dependent; reversible after treatment discontinuation•Phase 2 in ABSSSI •Brilacidindosed in > 300 patients•Effective; Generally safe and well-tolerated•Phase 2a data presented at ICAAC, 2012•PK/PD data presented at ECCMID, 2013•Phase 2b data presented atECCMID, 2015

https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf

•Single-dose brilacidinwas safe and well tolerated in a phase 2b ABSSSI study•Reduction in total dose decreases the frequency, severity, and duration of adverse events, vs. phase 2a study•Blood pressure events low in 0.6 mg/kg single-dose regimen, similar to or better than daptomycin(active control)•There were no treatment-related SAEs or hypertension-related SAEs•Numbness/Tingling mild, transient, and decreased in frequency and severity, vs. phase 2a study•PK/PD model correctly predicted decrease in AEs with lower total dose, particularly low single-dose regimens

https://investorshub.advfn.com/secure/post_reply.aspx?message_id=158016861

As I mentioned IPIX has reported covid19 is responsive to Brilacidin at a lower dose which would further reduce the paresthesias

GLTA Farrell