The company provided top-line data results for its psoriasis Phase 2c trial in a PR today. There is a significant amount of knowledge and information behind the top-line results within the full dataset (by definition), as there were for the atopic dermatitis Phase 2 and psoriasis Phase 2b trials.
Data analysis. Below is a simple comparison of available top-line results from the 2b and 2c trials.
- Reproducibility achieved: I think the Phase 2b (0.001%) and 2c (0.002%) trials yielded comparable data of consistent disease metric improvement.
- No vehicle effect seen: The vehicle was inferior to all 2c arms and in comparison to the 2b trial. I think there was no clear trend for the vehicle in the 2c trial.
- Continued robust safety: I think there were no significant safety issues or adverse events identified in any of PH-10 dose groups of the 2c trial, which compares favorably to the safety outcome of the 2b trial.
- Continue good efficacy (again restrained by the trial design, by design). The 2c trial (and, by extension the 2b trial) demonstrated all of the active arms were effective and superior to the vehicle. I also think patients did not relapse (i.e., there was no substantial rebound after administration of PH-10 was stopped). It is obvious the 28-day period limited efficacy, so neither the 2b or 2c trials provided optimal or "more optimal" conditions under which to achieve [much] better efficacy. For example, I think the consistent trends across both Phase 2 studies indicate suggest continued improvement is likely with extended treatment of, say, up to 12 weeks.
- Good knowledge with which to design a pivotal phase 3 trial design. The 2c trial design was a standard design for the FDA to approve a dermatology product. A pivotal phase 3 trial design simply would be a larger version of the vehicle-controlled 2c trial; however, management now knows, among other things, (a) how to optimize around the .001% and 0.002% dosing (versus higher concentrations, which probably acted like sunscreen and limited the activation of the active ingredient) and (b) how optimize the application period.
Keep in mind. A true assessment of the value of PH-10 is multi-dimensional: safety (risk), efficacy (reward) and price (to the patient to buy)-cost (to the company/licensee to produce).