Replies to post #337092 on Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

I am not aware of the RBL recommending a specific dose.The RBL reports do suggest a lower dose for the Covid trial than was used in ABSSSI 2b trial.Calculating drug doses from in vitro data is tricky,but the ABSSI data will be very helpful in calculating the Covid study dose.

https://www.fda.gov/media/72309/download

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529745/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742935/

Consulting companies are available to calculate trial doses.

https://www.nuventra.com/

"The new data, using the same assay method, reveal Brilacidin exhibited a similarly potent inhibitory effect against SARS-CoV-2 at an even lower concentration in the same human lung epithelial cell line. Brilacidin achieved approximately 90 percent inhibition of SARS-CoV-2 at a drug concentration that was one-half lower than previously tested. The lowest concentration of Brilacidin used in RBL testing to date is well below the clinically-achievable concentration based on the pharmacokinetics observed in the Company’s Phase 2b clinical trial of Brilacidin in Acute Bacterial Skin and Skin Structure Infections."

http://www.ipharminc.com/press-release/2020/7/20/innovation-pharmaceuticals-brilacidin-inhibits-novel-coronavirus-covid-19-by-almost-90-at-the-lowest-concentration-tested-to-date-in-a-human-lung-cell-line

Of note, the IC50(0.565µM) and IC90(2.63µM) values for brilacidin observed in the Calu-3 cell line are well below clinically-achievable concentrations based on pharmacokinetics observed in a Phase 2b clinical trial of brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI): median Cmax in plasma was 7.67µM brilacidin (free-base) from a single IV dose of 0.6 mg/kg.

http://www.ipharminc.com/new-blog/2020/10/30/preprint-brilacidin-a-covid-19-drug-candidate-exhibits-potent-in-vitro-antiviral-activity-against-sars-cov-2