Phase 2b Trial of Psoriasis Therapy Prurisol Reaches 70% of Participant Target

Phase 2b Trial of Psoriasis Therapy Prurisol Reaches 70% of Participant Target

An already started Phase 2b clinical trial of Prurisol as a treatment for moderate-to-severe chronic plaque psoriasis has recruited more than 70 percent of the 189 participants that researchers hoped for.

The therapy’s developer, Cellceutix Corporation, said it expects to release the trial’s initial results during the third quarter of 2017.

Prurisol is an oral immunomodulatory therapy that reduces the expression of an RNA molecule called PRINS whose function has yet to be determined. PRINS stands for Psoriasis susceptibility-related RNA Gene Induced by Stress. Expression is the process by which information from a gene is used to create a functional product like a protein.

Cellceutix is following a regulatory path that it hopes can accelerate Prurisol’s U.S. approval. The Federal Drug Administration allows a company to use long-term safety results of an approved drug that is similar to its own when it seeks its candidate’s approval. In this case, the drug is a Prurisol bioequivalent called Ziagen.

Researchers have completed a 12-week Phase 2 clinical trial (NCT02494479) of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Two Prurisol doses were tested, with the study showing that the higher one improved patients’ psoriasis. The therapy was also well tolerated, the trial showed.

The Phase 2b trial that Cellceutix is now conducting (NCT02949388) is randomized, double-blind, parallel-group and placebo-controlled. It is assessing the drug’s effectiveness at doses higher than the 200 mg per day that researchers found to be successful in the previous trial.

Researchers are testing doses of 300 and 400 mg per day in the new trial. Patients who are already enrolled are already receiving one of the two.

The team is using patients’ Psoriasis Area and Severity Index (PASI) scores at the start and finish of the 12-week testing period to evaluate Prurisol’s effectiveness.

The trial’s primary goal is a 75% reduction in PASI scores over the 12 weeks. An interim analysis of effectiveness will be done after six weeks.

The effectiveness of current psoriasis treatments diminishes over time, and the therapies have side effects.

Cellceutix expects Prurisol to prove safe and effective not only for chronic plaque psoriasis but also for psoriatic arthritis, rheumatoid arthritis and other conditions.

4 comments

  1. Luladey says:

    I’ve used about everything on the market and love dermalmd psoriasis serum. When it came out recently I bought it at Walgreens and then couldn’t get it again as it was out of stock. So, Amazon to the rescue again and at a cheaper price! Psoriasis is very complicated, what works for one person may very well not work for another. I’ve spent much more on other products that did absolutely nothing, this worked for me, thank goodness.

  2. Georgejjl says:

    Prurisol sounds amazing for a oral pill taken every 12 hours.

    “…Among patients with the severest form of psoriasis in study, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46% of patients who received 200 mg per day. These data were derived from analyses of all patients….”

    Subjects in the current trial are getting either 400 mg/day, 300 mg/day or a placebo.

    See pages 10 through 29 at the following link

    https://static1.squarespace.com/static/5715352e20c647639137f992/t/5865318920099e2bc425d577/1483026833173/Cellceutix_Corporate_Slide+Deck_DERMATOLOGY_November+2016+Website+Vers.pdf

    The Prurisol Phase 2b trial is currently ongoing and still recruiting patients at 29 sites across the USA.

    https://clinicaltrials.gov/ct2/show/NCT02949388?term=NCT02949388&rank=1

    Good luck and GOD bless,

    George

  3. Donna Moore says:

    They need to figure out a way to send the researchers to the patient instead of the patient to the researchers.
    I have both psoriasis and psoriatic arthritis but live in the sticks.

    • Georgejjl says:

      Donna,

      I hope that you find a good treatment.

      Do you live near any of the 29 trial sites that are currently recruiting for the Prurisol trial?

      Locations
      United States, Arizona
      Study Site Recruiting
      Glendale, Arizona, United States, 85308

      Clinical Study Site Recruiting
      Rogers, Arizona, United States, 72758

      United States, Arkansas
      Study Center Recruiting
      Hot Springs, Arkansas, United States, 71913

      United States, California
      Clinical Study Site Recruiting
      Murrieta, California, United States, 92562

      Clinical Study Site Recruiting
      Oceanside, California, United States, 92056

      Study Site Recruiting
      Sherman Oaks, California, United States, 91403

      United States, Colorado
      Study Site Recruiting
      Denver, Colorado, United States, 80209

      Clinical Study Site Recruiting
      Denver, Colorado, United States, 80210

      United States, Florida
      Study Site Recruiting
      Port Orange, Florida, United States, 32127

      Clinical Study Site Recruiting
      Tampa, Florida, United States, 33609

      United States, Illinois
      Study Center Recruiting
      Arlington Heights, Illinois, United States, 60005

      United States, Indiana
      Clinical Study Site Recruiting
      South Bend, Indiana, United States, 46617

      United States, Kansas
      Study Center Recruiting
      Overland Park, Kansas, United States, 66215

      United States, Kentucky
      Study Site Recruiting
      Louisville, Kentucky, United States, 40217

      United States, Michigan
      Clinical Study Site Recruiting
      Clarkston, Michigan, United States, 48346

      Clinical Study Site Recruiting
      Clinton, Michigan, United States, 48038

      United States, Missouri
      Clinical Study Site Recruiting
      Saint Louis, Missouri, United States, 63117

      United States, New Hampshire
      Clinical Study Site Recruiting
      Portsmouth, New Hampshire, United States, 03801

      United States, New Jersey
      Clinical Study Site Recruiting
      Berlin, New Jersey, United States, 08009

      United States, New York
      Clinical Study Site Recruiting
      New York, New York, United States, 10012

      United States, Oregon
      Clinical Study Site Recruiting
      Portland, Oregon, United States, 97210

      United States, Rhode Island
      Study Site Recruiting
      Johnston, Rhode Island, United States, 02919

      United States, Texas
      Study Center Recruiting
      Austin, Texas, United States, 78759

      Clinical Study Site Recruiting
      Houston, Texas, United States, 77004

      Clinical Study Site Recruiting
      Pflugerville, Texas, United States, 78660

      Clinical Study Site Recruiting
      San Antonio, Texas, United States, 78213

      Clinical Study Site Recruiting
      San Antonio, Texas, United States, 78229

      Study Site Recruiting
      San Antonio, Texas, United States, 78229

      United States, Virginia
      Study Center Recruiting
      Charlottesville, Virginia, United States, 22911

      https://clinicaltrials.gov/ct2/show/NCT02949388?term=NCT02949388&rank=1

      Good luck and GOD bless,

      George

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