Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2b Study of Oral Prurisol for Psoriasis
November 30, 2017
Prurisol
BEVERLY, Mass., November 30, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that the last patient has completed study treatment in the Company’s Phase 2b trial of Prurisol for the treatment of psoriasis. Prurisol is being developed as a novel, nonbiologic, oral psoriasis drug candidate.
A total of 199 patients were enrolled in the clinical trial (see NCT02949388), which includes: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit at 4 weeks, post-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 to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization).
Primary efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs. In addition, multiple secondary endpoints will be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.
In a previous Phase 2 trial studying Prurisol in mild-to-moderate psoriasis (see NCT02494479), Prurisol demonstrated early efficacy and was shown to be well-tolerated. A summary of these Phase 2 study results, presented at the 14th Annual Discovery on Target Conference, which was held on September 19, 2016, can be accessed at the link below.
· “Prurisol: A New Small Molecule Under Investigation for the Treatment of Psoriasis”
http://www.ipharminc.com/s/Prurisol-Presentat...2016-u.pdf
“With all patients having received treatment, we look forward to wrapping up the Phase 2b Prurisol trial,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Only a handful of patient follow-up visits remain to be completed. A novel psoriasis drug, particularly one that is oral, safe and effective, would be well-received by clinical practitioners and patients alike, both looking for newer treatment options to help manage this debilitating skin disease.”
About Psoriasis
Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities.
Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
http://www.ipharminc.com/press-release/2017/1...-psoriasis
November 30, 2017
Prurisol
BEVERLY, Mass., November 30, 2017 (GLOBE NEWSWIRE) – Innovation Pharmaceuticals Inc., (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that the last patient has completed study treatment in the Company’s Phase 2b trial of Prurisol for the treatment of psoriasis. Prurisol is being developed as a novel, nonbiologic, oral psoriasis drug candidate.
A total of 199 patients were enrolled in the clinical trial (see NCT02949388), which includes: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit at 4 weeks, post-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 to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization).
Primary efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs. In addition, multiple secondary endpoints will be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.
In a previous Phase 2 trial studying Prurisol in mild-to-moderate psoriasis (see NCT02494479), Prurisol demonstrated early efficacy and was shown to be well-tolerated. A summary of these Phase 2 study results, presented at the 14th Annual Discovery on Target Conference, which was held on September 19, 2016, can be accessed at the link below.
· “Prurisol: A New Small Molecule Under Investigation for the Treatment of Psoriasis”
http://www.ipharminc.com/s/Prurisol-Presentat...2016-u.pdf
“With all patients having received treatment, we look forward to wrapping up the Phase 2b Prurisol trial,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Only a handful of patient follow-up visits remain to be completed. A novel psoriasis drug, particularly one that is oral, safe and effective, would be well-received by clinical practitioners and patients alike, both looking for newer treatment options to help manage this debilitating skin disease.”
About Psoriasis
Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities.
Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
http://www.ipharminc.com/press-release/2017/1...-psoriasis
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