Great results today, considering the bar was set v
Post# of 72447
Posted On: 05/24/2016 1:41:53 PM
Great results today, considering the bar was set very high to begin with. The dosing was relatively short and only one lesion was being evaluated. If the primary endpoint was one point improvement on the IGA scale instead of two, the response rate should be much higher. In the 200mg arm, the response rate is ~2x of the placebo rate or ~3x if non-compliance is removed, not bad. Response rate could be better with possible higher dosing regimens in the next trial.
Side effects are big concerns for biologics, so no SAE in the 200mg arm is significant. Prurisol will capture some market shares if its efficacy is comparable to other blockbusters in Phase 3. Which one would you rather take? An oral drug without SAEs or a needle with SAEs? I bet at least one BP is smart enough to see the potential.
If P is the riskiest project among the Big Three, K and B will be just fine. The most important takeaway in the PR is that P works in humans and it further validates Dr. Menon’s expertise in pre-clinical studies. The man still has a perfect batting average. Next up, B-OM.
https://www.thelifesciencesreport.com/pub/na/...al+3-14-16
Side effects are big concerns for biologics, so no SAE in the 200mg arm is significant. Prurisol will capture some market shares if its efficacy is comparable to other blockbusters in Phase 3. Which one would you rather take? An oral drug without SAEs or a needle with SAEs? I bet at least one BP is smart enough to see the potential.
If P is the riskiest project among the Big Three, K and B will be just fine. The most important takeaway in the PR is that P works in humans and it further validates Dr. Menon’s expertise in pre-clinical studies. The man still has a perfect batting average. Next up, B-OM.
Quote:
Nearly all biotechs developing a psoriasis drug target the moderate-to-severe patient class, but not Cellceutix in its Phase 2 study. Ehrlich explained that the company's confidence in Prurisol led to the decision to evaluate the drug under some of the most difficult situations, and that meant a short-duration study evaluating only one particular lesion in patients being treated with an oral drug (Prurisol). "It doesn't get much more difficult than that," Ehrlich said. "But, by going with a short study, we saved money, challenged our drug, and will have plenty of data for a late-stage trial."
Ehrlich further explained that by taking this approach, Cellceutix is assessing Prurisol's potential for two "huge markets," mild-to-moderate psoriasis and moderate-to-severe psoriasis. "It's a little more savvy approach than one might think at first blush," and one Ehrlich thinks the market may be overlooking.
https://www.thelifesciencesreport.com/pub/na/...al+3-14-16
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