Innovation Pharmaceuticals Inc (IPIX)

[makarr]

Well, if you remember Otezla's development, I think that the Prurisol data is actually quite good.

In ph 3 of apremilast, only 33% of those being treated reached the endpoint, which was actually below the best result they saw in one of their multiple phase II trials (41%). Some of the lower doses barely outdid placebo, and none of them ever really exceeded a 29% response rate.

If you contrast the CTIX results to this, I think it is actually quite promising. First, there were no real SAE's, which is important because of the difficulty of using biologics; this is why Otezla sells at all in the first place. Second, its efficacy (either 35% or 43.7%, depending on which data you like to use) was at the very least comparable to Otezla. I usually am wary of cherry-picking subset data, but the wide range in dosing in Prurisol indicates to me that the management genuinely did not know what range would be effective or not, and likely preferred to err on side of caution, as the worst thing for them would be to witness high rates of dropouts due to SAE's.

I think it is also of note that the placebo leg in CTIX's trial had an abnormally high rate of efficacy (16.7%) vs. those of the Celgene trials, all of which were in the 5-10%. Perhaps this could be attributed to randomness and if that # decreased in a Ph.3, that could make the trial look even more appealing.

All this to say, I doubt that CTIX will be able to prove superiority of Prurisol to Otezla based on these study results. HOWEVER, I do believe that the drug has shown efficacy, certainly enough to warrant a Ph. 3 trial, and likely enough to become a serious competitor to Otezla in what is a pretty huge market. Pretty good for a compound most considered an after-thought compared to Kevetrin and Brilacidin.

http://www.ncbi.nlm.nih.gov/pubmed/26089047

http://www.ncbi.nlm.nih.gov/pubmed/22748702

http://www.ncbi.nlm.nih.gov/pubmed/23030767