Most IPIX investors feel pretty confident that Brilacidin has shown itself to be a multi-billion dollar drug with its 3 trials showing that it was highly effective against IBD (Ulcerative Colitis and UPS) based on the phenomenal photos of the intestines showing them to be as clean as the insides of a new stainless steel pipe, Oral Mucositis, and ABSSSI (antibiotic).
The only remaining trial results currently is for Prurisol P2b and those results are expected to become the basis for how Leo wants to move the company forward and what specific drugs/indications (if any) he wants to partner out at this time or if a sale of a platform or the whole company is in the best interests of stockholders.
So lets look at the P2b trial results and why so many are so excited about them and if this excitement is justified. Prurisol (per company website) is under FDA 505b2 development approach which expedites its FDA approval based on existing long term safety data of an already approved drug. In Prurisol's case, this drug is Ziagen. This is great for the safety side as one of the two primary endpoints is no adverse events in the trial due to safety. Everyone has seen the ads for biologics and Otezla where the side effects can be quite hazardous, so Prurisol having no major side effects will give us a major leg up on ALL competition. So that means that our main area of concern will be efficacy. Why are so many exuberant about the expected efficacy of Prurisol in the P2b trial?
We start with the pre-clinical work of Prurisol and the HUMAN psoriatic tissue that was transplanted into mice which, when treated with Prurisol, showed a near miraculous cure of the psoriasis, not just a clearing up of the symptoms. Those pics are as strong a case as was the intestinal photos for Brilacidin-IBD. We then proceed to look at the P2b trial and the fact that IPIX (like all clinical trial pharmas) used the P2a trial data to construct the P2b to highlight the strengths of Prurisol. The trial differs in some pretty major areas to the P2a in that ALL patients are clean, meaning that they have not undergone ANY prior psoriasis treatments with biologics or Otezla. This was not the case with P2a and should aid the positive responses to Prurisol. Secondly, only moderate to severe psoriasis cases were admitted thus lowering the chances greatly that the placebo arm will show much effectiveness. Finally, we are using the PASI standards to judge the results and from what I have been told this usually increases positive data compared to the other standard which was used in the P2a (I think the score on the other standard is a secondary endpoint). We have raised the dosage 50% and 100% in the 300/400 arms. In the P2a, it appeared from the graphs that Prurisol just started working at about the 200 dosage level, so the 300 is expected to be the sweet spot by many as to efficacy and the 400 arm is to show the FDA that there is not much reason to go above 300 as it should level off near a horizontal line in regards to increased efficacy past the 300 level (I have no data to back up this point, it was just passed on to me by a dermatologist who was familiar with prior psoriasis trials. He also said it was important to show the FDA that a dosage was tested that didn't continue to show a distinct improvement of a lower dosage.
The final strength of how confident mgt is regarding the results expected from the P2b is the questionnaire that each patient filled out 4 weeks after the end of treatment. NOTE: THIS QUESTIONNAIRE WAS NOT REQUIRED FOR THE P2B TRIAL. IT IS STRICTLY AT THE DESIRE BY MGT TO SHOW HOW GREAT IS THE QUALITY OF LIFE IMPROVEMENT RECEIVED BY PATIENTS.This questionnaire was for the most part a quality-of-life survey and should go a long, long, long way in giving a full view of how patients reacted to Prurisol other than just the black and white pass/fail percentage of the primary endpoints in regards to PASI75 percentage. If we get excellent primary endpoint results with very strong secondary endpoint results from the quality-of-life questionnaire and attach this to the 505b2 safety channel the Phase 3 for Prurisol IMO should be pretty sweet, meaning fairly small and fast. Completely different from the massive B-ABSSSI the FDA has told the company they must complete.
Now if all the above is true, what does Leo do? I have heard remarks of taking a couple of billion for Prurisol and let the BP bear the costs of future P3 and bringing drug to commerciality. But is this best for us shareholders? If all we need is a fairly fast, small P3 the cost should only be a few million dollars. I for one would say raise the money thru dilution, run the P3 (or at least threaten BP that I will run the P3 myself), and then BP can kiss my can if they think after we ace the P3 that we will let the Prurisol psoriasis indication go for anything less than decent double digit Billion dollar pricing. If all the above pan out, Prurisol will be the first-in-class recommended treatment (why go with a more costly, riskier, and fairly short lived improvement by the biologics or the less efficacious and more risky Otezla?) and most likely bring in over $100B in its 15-20 yr patent period?
I eagerly await P2b results, excited but certainly not worried.
The only remaining trial results currently is for Prurisol P2b and those results are expected to become the basis for how Leo wants to move the company forward and what specific drugs/indications (if any) he wants to partner out at this time or if a sale of a platform or the whole company is in the best interests of stockholders.
So lets look at the P2b trial results and why so many are so excited about them and if this excitement is justified. Prurisol (per company website) is under FDA 505b2 development approach which expedites its FDA approval based on existing long term safety data of an already approved drug. In Prurisol's case, this drug is Ziagen. This is great for the safety side as one of the two primary endpoints is no adverse events in the trial due to safety. Everyone has seen the ads for biologics and Otezla where the side effects can be quite hazardous, so Prurisol having no major side effects will give us a major leg up on ALL competition. So that means that our main area of concern will be efficacy. Why are so many exuberant about the expected efficacy of Prurisol in the P2b trial?
We start with the pre-clinical work of Prurisol and the HUMAN psoriatic tissue that was transplanted into mice which, when treated with Prurisol, showed a near miraculous cure of the psoriasis, not just a clearing up of the symptoms. Those pics are as strong a case as was the intestinal photos for Brilacidin-IBD. We then proceed to look at the P2b trial and the fact that IPIX (like all clinical trial pharmas) used the P2a trial data to construct the P2b to highlight the strengths of Prurisol. The trial differs in some pretty major areas to the P2a in that ALL patients are clean, meaning that they have not undergone ANY prior psoriasis treatments with biologics or Otezla. This was not the case with P2a and should aid the positive responses to Prurisol. Secondly, only moderate to severe psoriasis cases were admitted thus lowering the chances greatly that the placebo arm will show much effectiveness. Finally, we are using the PASI standards to judge the results and from what I have been told this usually increases positive data compared to the other standard which was used in the P2a (I think the score on the other standard is a secondary endpoint). We have raised the dosage 50% and 100% in the 300/400 arms. In the P2a, it appeared from the graphs that Prurisol just started working at about the 200 dosage level, so the 300 is expected to be the sweet spot by many as to efficacy and the 400 arm is to show the FDA that there is not much reason to go above 300 as it should level off near a horizontal line in regards to increased efficacy past the 300 level (I have no data to back up this point, it was just passed on to me by a dermatologist who was familiar with prior psoriasis trials. He also said it was important to show the FDA that a dosage was tested that didn't continue to show a distinct improvement of a lower dosage.
The final strength of how confident mgt is regarding the results expected from the P2b is the questionnaire that each patient filled out 4 weeks after the end of treatment. NOTE: THIS QUESTIONNAIRE WAS NOT REQUIRED FOR THE P2B TRIAL. IT IS STRICTLY AT THE DESIRE BY MGT TO SHOW HOW GREAT IS THE QUALITY OF LIFE IMPROVEMENT RECEIVED BY PATIENTS.This questionnaire was for the most part a quality-of-life survey and should go a long, long, long way in giving a full view of how patients reacted to Prurisol other than just the black and white pass/fail percentage of the primary endpoints in regards to PASI75 percentage. If we get excellent primary endpoint results with very strong secondary endpoint results from the quality-of-life questionnaire and attach this to the 505b2 safety channel the Phase 3 for Prurisol IMO should be pretty sweet, meaning fairly small and fast. Completely different from the massive B-ABSSSI the FDA has told the company they must complete.
Now if all the above is true, what does Leo do? I have heard remarks of taking a couple of billion for Prurisol and let the BP bear the costs of future P3 and bringing drug to commerciality. But is this best for us shareholders? If all we need is a fairly fast, small P3 the cost should only be a few million dollars. I for one would say raise the money thru dilution, run the P3 (or at least threaten BP that I will run the P3 myself), and then BP can kiss my can if they think after we ace the P3 that we will let the Prurisol psoriasis indication go for anything less than decent double digit Billion dollar pricing. If all the above pan out, Prurisol will be the first-in-class recommended treatment (why go with a more costly, riskier, and fairly short lived improvement by the biologics or the less efficacious and more risky Otezla?) and most likely bring in over $100B in its 15-20 yr patent period?
I eagerly await P2b results, excited but certainly not worried.
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