Innovation Pharmaceuticals Inc (IPIX)

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The Competition - Otezla

Otezla data - FDA

Pulled the Apremilast approval docs for closer look at what the bar is for Prurisol

In the 2 pivotal Otezla trials (pg 17-19)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000StatR.pdf

PRIMARY EFFICACY

1. PASI 75
- 33.1% Otezla vs 5.3% placebo
- 28.8% Otezla vs 5.8% placebo

MAJOR SECONDARY EFFICACY

2. sPGA (0 or 1 w/at least 2-pt drop from baseline)
- 21.7% Otezla vs 3.7% placebo
- 20.4% Otezla vs 4.4% placebo

OTHER EFFICACY

1. PASI 50
- Otezla 58.7% vs 17% placebo
- Otezla 55.5% vs 19.7% placebo

2. Achieved PASI 75 and sPGA 2-pt drop
- 20.3% Otezla vs 3.5% placebo
- 18.6% Otezla vs 4.4% placebo

Other factors: Otezla took 16 weeks to get to these numbers and only around 8% achieved PASI 90

Prurisol Phase 2b switches from IGA to PASI 75 as primary so we'll have a direct comparison on the Primary -- also have as Secondary Outcome the sPGA 2-pt drop.

https://clinicaltrials.gov/ct2/show/NCT02949388

Getting ancy -- getting closer to Showtime, first look to see if Prurisol in the P2b is faster on the uptake and as good as (or maybe better than) Otezla -- daresay even eating into the biologics turf ... of course worst case, it fails (say it ain't so)

Tick tock, t-minus a couple months

The full FDA data archive on Apremilast / Otezla
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206088Orig1s000TOC.cfm


Side-effect of the competition - Otezla:

It's a low bar, with leeway given because it's an oral. And then there's this, Otezla safety (not stellar) which Prurisol already bettered in the Phase 2:

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/11/2016
Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor used to treat adult patients with active psoriatic arthritis. Common side effects of Otezla include:

diarrhea,
headache,
nausea,
upper respiratory tract infection,
vomiting,
runny or stuffy nose,
abdominal pain,
fatigue,
indigestion,
decreased appetite,
insomnia,
back pain,
frequent bowel movements,
depression,
bronchitis,
tooth abscess, and
sinus headache.
The recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6, after 5 days of an initial schedule of titration dosing. Otezla may interact with CYP450 inducers (such as rifampin). Tell your doctor all medications and supplements you use. During pregnancy, Otezla should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Otezla (apremilast) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Reading the following it's hard to imagine Purisol Phase 2b NOT achieving spectacular results!


What Prurisol did last Phase 2a trial:

Looking at the Phase 2a trial we had 28 patients in the 200mg arm.

Of the 28 patients 9 were Mild and 18 were Moderate psoriasis patients.

For the 200mg (28) arm and for Moderate (18) Psoriasis patients only,... 46% of those patients had a 2 point reduction using the IGA scale which translates roughly to PASI90.

Otezla had 8% PASI90,...

If we simply repeat the results of Phase 2a,... we get 46% PASI90

Things that are happening in Phase 2a that might increase that number for us:

1) we are now dosing at 300mg and 400mg

2) we are now dosing patients with Moderate/Severe Psoriasis instead of Mild/Moderate in Phase 2a. It is a given that Mod/Sev patients respond better than Mild/Mod.

Looking at Phase 2B we see we will have 27 patients dosing at 400mg,... twice the dosage of Phase 2a where we got 46% PASI90 using 18 patients!

It is possible that we might double the results

Imagine 90% PASI90,... stock price would open pat $10,.. deal or no deal.

And we know that Prurisol is dose dependant and that there is little liklyhood of adverse side effects as it has been tested for safety up to 600-800mg

We will also have 81 patients dosing at 300mg (50% higher than Phase 2a),... so if we follow with an equal percentage gain of 50%,..

That could translate to 70% PASI90 in a very strong statistical study!