Provectus Pharmaceuticals has reported positive top-line data for PH-10 in the randomised controlled trial (RCT) conducted in mild-to-moderate plaque psoriasis patients.
The study compared safety and efficacy of three dose levels of PH-10 (0.002%, 0.005% and 0.01% Rose Bengal) against vehicle.
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The Phase II trial randomised 99 patients to one of the four study arms and applied their assigned test article once daily for 28 consecutive days.
Provectus CEO Craig Dees said the four-arm study clearly showed that the low dose level was optimal of the three doses tested, with similar activity to that seen in the earlier single-arm trial, and that it was superior to vehicle.
"We expect that the data from this randomised study will eventually lead to a term sheet for a proposed licensing agreement, which will trigger the engagement of a financial advisor to assist us with that transaction," Dees added.
The Psoriasis Severity Index (PSI), the Plaque Response Assessment scale, and the Pruritus (itching) Self Assessment scale were used to assess the efficacy.
All three efficacy parameters showed improvement in psoriasis symptoms over the treatment interval.
The low dose of PH-10 (0.002%) provided uniformly consistent improvement, while the two higher doses demonstrated reduced therapeutic activity.
Response for PH-10 at 0.002% Rose Bengal was comparable to that observed previously using PH-10 at 0.001% Rose Bengal, the study reported.
23%-29% of subjects achieved complete or nearly complete resolution of all PSI component symptoms, after the treatment with all the strengths of PH-10, compared to no subjects in the vehicle arm.
PH-10 was generally well tolerated with only transient mild to occasionally moderate adverse experiences limited to the application site, the company said.
