Replies to post #361594 on Innovation Pharmaceuticals Inc (IPIX)

[Lemoncat]

I meant it had never shown success against other viruses or maladies aside from COVID. That is in contrast to Brilacidin which has demonstrated antibiotic and anti-inflammatory outcomes in multiple clinical trials.

In other words, Remdesivir has a history of not living up to in vitro results. Brilacidin has a history of success when in vitro results project it.

As for the question about the SOC, no boogeymen are necessary. Remdesivir clearly proved at mild but statistically significant improvement on mortality rates in a 1000+ person trial. The results aren't really inline with the potency of in vitro results on viral titers but it is something.

https://www.nejm.org/doi/full/10.1056/nejmoa2007764

The Kaplan–Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).

3.9 percentage points seems small but if 200,000 people died on Remdesivir then that means it saved 7,800 people over placebo. It's certainly better than nothing but definitely a let down from in vitro results.

The remdesivir study was early to the game as well at a time when there were even fewer treatment options and no vaccines. The FDA was certainly desperate to get anything with any credible results onto the market.

While we don't need to mention any boogeymen to answer why Remdesivir is the included in the SOC, I'm sure Gilead's multimillion dollar ($7,000,000) 2020 lobbying efforts did not hurt in achieving the status Remdesivir currently enjoys.

https://www.opensecrets.org/orgs/gilead-sciences/summary?id=D000026221

How can B be considered for an Emergency Use Authorization without being used in combination with some other drug when it isn't being tested alone?

I don't think it would. I assume any EUA would be stacked on top of Remdesivir. It's also why I think Gilead will be the most eager partner if Brilacidin does well. Either they will be able to reap the lion's share of Brilacidin revenues or they will be able to influence IPIX not to run a phase 3 trial arm without Remdesivir. Gilead will preserve their revenue stream one way or another.

I think IPIX would eagerly take a multi-hundred million dollar upfront payment to advance the rest of the pipeline and happily marry B-COVID to Remdesivir. Gilead would make that back in a couple of months. Everyone's problems all solved in one fell swoop.

Go IPIX!