Clinical Trials

Date: 2018-06-29

Type of information: Completion of the trial

phase: 2b

Announcement: completion of the trial

Company: Innovation Pharmaceuticals (USA - MA)

Product: prurisol

Action mechanism:

Prurisol is a small molecule that acts through immune modulation and PRINS reduction. In laboratory studies, prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis as well as in a xenograft model using human psoriatic tissue. Prurisol eliminated virtually all signs of psoriasis with no reoccurrence of the lesions. Prurisol is synthesized through a five-step process using commercially available starting materials.

Disease: moderate-to-severe plaque psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country: USA

Trial details:

A total of 199 patients were randomized in the clinical trial , which included:
a screening period of up to 4 weeks;
a treatment period of 12 weeks;
and a follow-up visit after 4 weeks off-treatment.
The randomized, double-blind, parallel-group and placebo-controlled study increased the total daily oral dosing of prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated and demonstrated early efficacy, to include oral prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization). Efficacy evaluation includes the Psoriasis Area and Severity Index (PASI) and a Physician Global Assessment. (NCT02949388)

Latest news:

• On June 29, 2018, Innovation Pharmaceuticals announced database lock for its Phase 2b clinical trial of oral prurisol in moderate-to-severe chronic plaque psoriasis. A total of 199 patients were randomized in the clinical trial , which included: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit after 4 weeks off-treatment. The randomized, double-blind, parallel-group and placebo-controlled study increased the total daily oral dosing of prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated and demonstrated early efficacy, to include oral Prurisol 300 mg per day, oral prurisol 400 mg per day, and placebo (3:1:3 randomization). Efficacy evaluation includes the Psoriasis Area and Severity Index (PASI) and a Physician Global Assessment.
• On December 21, 2017, Innovation Pharmaceuticals announced all patient follow-up visits have been completed in its Phase 2b clinical study of oral prurisol in moderate-to-severe chronic plaque psoriasis. The company looks forward to seeing the unblinded study results. Topline data are anticipated to be released in 1Q2018.

• On November 30, 2017, Innovation Pharmaceuticals announced that the last patient has completed study treatment in the Phase 2b trial of prurisol for the treatment of psoriasis. A total of 199 patients were enrolled in the clinical trial.
• On August 28, 2017, Cellceutix, now Innovation Pharmaceuticals, announced that it has met the goal of 189 patients enrolled in its ongoingPhase 2b clinical study of Prurisol for the treatment of moderate-to-severe psoriasis. The final number of patients will be up to 199, including those awaiting final screening test results through the end of this week (September 1). Based upon the protocol for 12 weeks of Prurisol treatment and additional patient follow-up for 4 weeks, the study is expected to be completed in Q4 2017, with results to follow thereafter.

• On December 19, 2016, Cellceutix announced that 24 of the 25 (all US based) core Phase 2b clinical trial sites for oral prurisol in the treatment of moderate-to-severe psoriasis have now been initiated and are open for screening, with the last site anticipated to follow later this week. The availability of the additional sites beyond those that have already begun to treat active study participants is expected to greatly facilitate timely completion of full enrollment. Interim analysis of 6-week data with readout is anticipated in 2Q2017, with full study top-line results in 3Q2017.

• On October 31, 2016, Cellceutix announced that it has begun the screening of patients in its Phase 2b clinical trial of oral prurisol for the treatment of moderate-to-severe chronic plaque psoriasis. This clinical trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment groups include oral prurisol 300mg per day, oral Prurisol 400mg per day, and placebo (3:1:3 randomization, respectively). Duration of treatment is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment. The study is being conducted at approximately 30 sites throughout the United States. This Phase 2b study increases the total daily dosing of prurisol above 200mg, the maximum level used in our previously successful Phase 2 trial, which showed the drug candidate to be a promising treatment for psoriasis. Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs.

• On July 7, 2016, Cellceutix announced the next phases of clinical and corporate development following the recent appointment of Arthur P. Bertolino, as President and Chief Medical Officer. Since successfully completing the initial Phase 2 trial of oral prurisol for mild to moderate plaque psoriasis, the company has fielded inquiries from many interested parties about the compound and has evaluated several options for the next stage of development. After a detailed analysis, the data clearly show that the most robust response to prurisol was in patients with moderate psoriasis in the trial’s highest dosing arm (200mg), with no serious adverse events reported. Benefits were apparent by two weeks and showed further improvement by the end of the study at 12 weeks. Cellceutix has begun preparing for a Phase 2b trial of prurisol for patients with moderate to severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses. The company intends to increase the dosing beyond 200mg and evaluate patients using the Psoriasis Area and Severity Index (PASI) scoring method.