Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

At this point the final review of the phase 2 study of Brilacidin for Covid has not been announced.

IPIX has stated entering the fully funded NIH ACTIV trials as a goal for Brilacidin.

As you know the next step for IPIX is planning its end of Phase 2 meeting with the FDA. IPIX has stated it will also review analysis of the compassionate use data which has not been released in addition to the final analysis of the Phase 2 data.

"The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year"

Law insider defines the end of phase 2 FDA meeting as follows:

"End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time..."

The phase 2 interim safety data was satisfactory in the Phase 2 study for Brilacidin for Covid which allowed the dosing to be increased to 5 days.



The answers to your questions are all here:

http://www.ipharminc.com/press-release/2021/12/7/innovation-pharmaceuticals-analyzing-full-dataset-for-its-brilacidin-covid-19-clinical-trial-company-evaluating-new-pipeline-opportunities-for-2022

http://www.ipharminc.com/press-release/2021/11/18/innovation-pharmaceuticals-provides-brilacidin-program-update

http://www.ipharminc.com/new-blog/2022/1/25/shareholder-alert-upcoming-update-on-brilacidin-in-covid-19

GLTA,Farrell