Innovation Pharmaceuticals Inc (IPIX)

[TheProgressive]

Here is my bottom line on Brilacidin for ABSSSI. I've had a bit of time to digest the protocol, and the thing that just keeps standing out to me is just how low the dosages are really going to be. Look at Dapto - they have to give 4mg/kg by IV for the dose to be effective. Our highest dosage arm is a mere 20% of that dose level for 14% of the duration! Wow, that just screams rapid and powerful response in comparison!

Of course, that's what the trial is for, to prove that these single doses really are that potent for a sustainable period of time to effectively squash any concerns of relapse or resistance, hence the 10-14 day, 21-28 day follow ups. I think the drug is so good that this is a case of "less is more", you hit the patient with initial dose and sit back and let this novel agent do its thing. The very limited SAE that were seen in a few isolated cases in the 2A trial I fully expect to be mitigated with the lower doses, again, you just don't need very much of this drug for it to be effective and safe.

Another important factor is the speed at which Brilacidin starts to work on the infection, bacteria just does not have a chance to develop resistance and outsmart the drug due to the novel MOA and the rapid nature of how it is exploited. The single doses effectively eliminate the concern of patient non-compliance, as some patients stop taking multi day regimen antibiotics when they feel/look "better", and bacteria then develops resistance before it's completely wiped out. Impossible for this to be an issue if a single dose is all that is needed, because that is the entire regimen! Even the 3day dosing arm would be a significant upgrade over 7 days of dapto. Take a look at this section of the protocol :

"Eligible subjects will be randomized to one of 4 treatment groups in a 1:1:1:1 ratio. Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6 mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6 mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily placebo. Subjects randomized to daptomycin will receive 7 days of treatment. Subjects will be assessed for both clinical and microbiologic efficacy 48-72 hours after the first dose of study drug. After an assessment at Day 7-8, subjects will be again be evaluated for efficacy at Day 10-14 and via a phone contact at Day 21-28."

As they know from the 2A trial and have built into the 2B protocol, they are expecting B to start working and showing very rapid results, again supporting the short dosage duration. As to what gives me confidence that the efficacy will be comparable to dapto with such low single doses - listen carefully to Dr. jorgensen's presentation from the biotech conference. Specifically from about 21:00 into the presentation where he mentions the very extensive and comprehensive PK/PD analysis that was done by Dr Paul Ambrose and his team at ICPD. (http://www.icpd.com/PaulAmbrose) A very impressive bio, this guy is top of his field in terms of evaluating PK/PD and using that analysis to efficiently model the most effective doses for a treatment moving forward. ICPD's extensive modeling and analysis of the entire Brilacidin preclinical / phase 1 / phase 2a database basically clearly revealed 2 key points:

1. Any of the limited adverse effects that occurred in the 2a trial happened due to the accumulation from higher doses in a multi day dosing regimen. (Which was 5 days in the 2A trial)

2. Efficacy, although comparable to dapto at the higher dosages over 5 days, was at a flat point of the dose response curve. So basically, they realized that giving more offered no more additional efficacy, and in fact the PK/PD modeling data (which was supported by the FDA) showed that it was possible to give less of the drug, for less time, and still have the excellent efficacy that was shown in the 2A trial.

So if Dr. Ambrose, Dr. Jorgensen, and the FDA are all aligned and in agreement on the comprehensive PK/PD analysis and modeling that was completed, this gives me all the confidence I need moving forward that this 2B ABSSSI trial will be a big success, and I do agree with you that the stock price from just this indication alone can triple the stock price by year's end.

Of course, anything can happen in the trial, but as I confidently stood behind Dr Menon and his extensive cache of Kevetrin pre-P1 data, i feel the same degree of confidence and conviction that the Brilacidin pre-2B modeling and data will yield a very successful result where B matches up with dapto, on a single dose, therefore making it a very lucrative drug that will move the SP to $5-6 by year's end.

Leo really did pull off one hell of an acquisition here, I think this trial will also go a long way in silencing any remaining skeptics of Leo and his capacity to make the moves needed to bring immense value to shareholders. Great job Leo!!! Now let's get this trial started!!!

Hope this post made sense.