PH-10 for Psoriasis

Future Plans

  • A mechanism of action study is underway to assess the clinical and cellular response to PH-10's active investigational agent.
  • A total of 226 subjects have been treated with PH-10 in Phase 1 or Phase 2 clinical trials.

Phase 2c Clinical Trial

  • In February 2012, final data collection for primary outcome was completed. All three treatment arms showed improvement over the vehicle arm, with the low-dose (0.002% RB) providing uniformly consistent improvement for all PSI efficacy parameters over the treatment interval. In the treatment arms, 23-29% of subjects achieved complete or nearly complete resolution of all PSI component symptoms (erythema, induration and desquamation), compared to no subjects in the vehicle arm.The full clinical study report was submitted to FDA in February 2014.
  • In August 2011, the study was completed. There were 99 subjects included in the Phase 2c study, assigned randomly to one of the four study arms.
  • In May 2011, patient accrual was completed, with more than 90 subjects enrolled.
  • In December 2010, a Phase 2c dose-randomized, vehicle-controlled study of PH-10 aqueous hydrogel for the treatment of plaque psoriasis was initiated. This multicenter study of an estimated 90 subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

    Treatment Cohorts:

    • PH-10 (0.002% Rose Bengal)
    • PH-10 (0.005% Rose Bengal)
    • PH-10 (0.01% Rose Bengal)
    • Vehicle

    Primary Outcome Measures:

    • The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
    • The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

    Secondary Outcome Measures

    • Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
    • Plaque Response score changes at each visit from Day 1 pre-treatment.
    • Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.

Phase 2b Clinical Trial

  • The Phase 2b study was completed in April 2010. There were 30 subjects treated in the completed Phase II study, and an additional 6 subjects were treated in an earlier study that was terminated in favor of an increased dosing frequency.
  • In December 2009, preliminary data for the Phase 2b study was released. 79% of the first 29 subjects to complete the trial demonstrated improvement in the Psoriasis Scoring Index (PSI). 83% of the subjects reported no or only mild pruritus (itching). There were no significant safety issues noted.
  • In October 2009, patient enrollment was completed for the 30 subject study that began in July 2009.
  • A second clinical site, International Dermatology Research in Miami, began patient enrollment in July 2009.
  • In July 2009 a Phase 2b study was initiated, supplanting the earlier study that was terminated in June 2009. Preliminary analysis of the data from the first 6 subjects to complete the earlier study, along with the data from an on-going Phase II study of PH-10 for atopic dermatitis, showed that an increased dosing frequency was both safe and appropriate. The new study changed the dosing frequency to daily for 28 days, rather than twice weekly for 12 weeks.
  • In June 2009, the Phase 2 study that was initiated in November 2007 was terminated in favor of a new Phase 2b study using an increased dosing schedule.
  • Patient enrollment began in November 2007 at the Mount Sinai School of Medicine in New York.
  • A Phase 2 study of PH-10 for the treatment of plaque psoriasis was initiated in November 2007. This is an open label, single center, controlled study. For each subject, three distinct plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one untreated plaque area. One treatment area will receive PH-10 with ambient light exposure, and the other treatment area will receive PH-10 with 10 J/cm2 of 544 nm LED light exposure. The untreated third plaque area will serve as an internal control. Both treatment areas will receive treatment twice weekly for up to 12 weeks.

    Primary Outcome Measures:

    • Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.

    Secondary Outcome Measures

    • Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.
    • Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area.
    • Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.
    • Adverse Experience.

Phase 1 Clinical Trial

  • A total of 40 subjects were treated in this Phase 1 study. No pain, significant side effects, or evidence of "rebound" were observed in any of the treated plaque areas. Follow-up examinations showed an average reduction in the thickness of treated plaque areas of 59% at 30 days post-treatment, and further response was noted atthe final follow-up examination at 90 days post-treatment.
  • A Phase 1 study of PH-10 for the treatment of psoriasis was initiated in April 2001. This study evaluated the safety of three different doses of PH-10 in separate patient treatment groups. Subjects in the study each received a single dose of PH-10 followed by administration of green light on psoriatic plaques. Subjects were examined post-treatment, with a final follow-up examination at 90 days.
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