Must-read post by DaubersUP on Prurisol. Pruris

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Prurisol's Importance: data

We are nearing the very important and highly anticipated release of interim data for Prurisol for Moderate-Severe psoriasis. I wanted to put out an email with some very encouraging data and facts that I have been researching over the past several weeks. So hopefully this dribble is worth your time and can hopefully give you an appreciation for what is about to be released.

First, please understand that with regards to market; Psoriasis is currently about an 8 billion market and should be around 9 billion in the next year or two. (2019)

Chart.

Biologics (Injections) are the most effective, but also hold the most severe side effects and the largest chance to become resistant. I think it's like a 33% chance they will no longer work after a certain amount of time.

For IPIX - The current phase 2b POWERED study is using criteria that will give an APPLES to APPLES readout to Otezla. They are using the PASI scale in which Otezla (Celgene's Blockbuster) used. Otezla is the leading ORAL psoriasis drug expecting to do about 2 billion in revenues this year. I will compare mostly with this drug.

The Prurisol phase 2a used the IGA scale. This scale is basically 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe)
The criteria was brutal, it was for MILD to MODERATE patients and the end result needed to show a GREATER THAN or EQUAL TO 2 point improvement. So for example, patients would need to have a 2 or 3 score and to end in a positive result the patient would need to go from 3 to 1 or 2 to 0. That is extreme. In PASI language that is basically saying they had a PASI 90 to PASI 100 score. The 50mg and 100mg arms in the Phase 2a did not show too much promise. But when the 200mg arm data was released this started to show some really good data.

To summarize:

Prurisol met the primary endpoint (2 pt reduction) in 35% of ALL patients who received a 200mg dose per day.
Even better, those patients that had a starting score of IGA 3 (MODERATE) who took 200mg met the 2pt reduction in 46% of patients. (VERY POSITIVE SINCE THE PHASE 2b IS FOR ALL MODERATE TO SEVERE AND AT MUCH HIGHER DOSES - 300mg and 400mg.)
NOTES - So we see that Moderate patients at 200mg had the best results. We don't know if it was a 2 or 3pt reduction, we just know they had ATLEAST 2pt reduction. Going from an IGA 3 to IGA 1 is in comparison to a PASI 90. So 46% had a PASI 90 in the moderate group. (Maybe not quite, but maybe)

In comparison: Otezla reaches PASI 75 around 30% and PASI 90 at 8%. And Otezla works around week 12-16. Prurisol starts showing improvements around week 4 and much larger psoriasis reduction around week 12.

OTEZLA DATA:
PRIMARY EFFICACY at 16weeks

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

I'm probably losing some of you, so basically Prurisol works faster and is more efficacious. Not to mention MUCH MUCH safer. Prurisol is part of an existing drug called Ziagen (HIV drug) so the safety profile is already proven and up to 600 mg. Due to this relation to Ziagen the FDA granted Prurisol a 505 2(b) meaning a much smaller phase 3 when the time comes and possibly only 1 phase 3 trial is needed and Prurisol could get 5 additional years of exclusivity (that equals BILLIONS more in revenues) We know that Prurisol is "dose dependent" meaning the more a patient receives the more efficacious it should be. Hence why 200mg worked way better than 50 and 100mg.

This powered phase 2b interim results will be data at week 6 for approximately 189 patients. We are now dosing at 300 and 400mg!!! So essentially we should see an even better read out of data. If this data shows a good % of PASI 75 at this 6 week juncture we could see a huge deal hit the wires. But I would assume Big Pharma wants the top line data which is set for late 2017. The 'primary' endpoint in this phase 2b is a PASI 75 readout. Like I said Otezla is ~30% PASI 75 - THAT IS THE BAR! If we top that we know we own the ORAL market. The kicker will be if we start to overlap into the Biologic's arena.

Here are some great charts for BIOLOGIC's

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Here is an opinion on where the bidding price action could start for Prurisol if data is comparable with the phase 2A data and matches or betters Otezla:

As to valuation: (from IHub)
> If Prurisol matches (betters) Otezla (~30% PASI 75, 20% sPGA 0/1) and faster on the uptake // ~$3billion starting bid
> If we approach Biologics numbers (50% PASI 75 and ideally higher, with PASI 90s+; ~40-50% sPGA 0/1) // ~$5 billion starting bid

Just remember for every billion that IPIX can get if they decide to sell Prurisol outright, it equals to about $6.25 per share FULLY diluted. (this means options etc)
So lets put a scenario together if they sell Prurisol (the dark horse drug) outright.

5 Billion sale = $31.25 per share with just cash in the bank, but then on top of that IPIX still has Brilacidin and Kevetrin which are the most valuable compounds in the pipeline and are worth much more than Prurisol when the dust settles. Add that the buyout of Prurisol will put IPIX on the Nasdaq where we get new/more investors and institutional buying in which we have zero currently. Sky could be the limit in a very short period if things all play out well with data.

Have a great day and hopefully this helps you all understand how important this interim and top line data could mean to all of us.

Disclaimer: I am long IPIX. An OTCBB biotech company can often have an enormous disconnect in regards to share price and market potential. This normally will reset once a third party verification or collaboration is made.

Cheers,

FOR THE MOST RECENT CONFERENCE CALL (6/8/17) - http://www.investorcalendar.com/event/15776

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