Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

The clinical trial outcomes for ABSSSI. There were problems with BP that were worrisome, but not enough to stop any trial. The issue was resolved by dose reduction of both frequency and amount. In the final trial for ABSSSI three were no safety issues.

Gosh, here’s one independent verification of safety:
The DSMB recommended that Cellceutix continue the trial as planned. That is the best possible outcome. Independent experts did not observe any concerning safety signals in the study. In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.

Previous brilacidin phase 1 and 2 studies have indicated the drug is safe and effective in the treatment of ABSSSI caused by Staph aureus, including methicillin-resistant Staph aureus (MRSA). Any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug. However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg), and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg). Of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012.
https://www.biospace.com/article/releases/cellceutix-brilacidin-absssi-trial-gets-positive-review-by-data-safety-monitoring-board-best-possible-outcome-no-treatment-related-serious-adverse-e/