Innovation Pharmaceuticals Inc (IPIX)

[DesireToLearn]

Prurisol. I took some snippets from the announcements back in May. Shows why such high confidence in Phase 2b.

 Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.
It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development
May 24, 2016

Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint

- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment

Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.
May 24, 2016

Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint

Prurisol

- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm
- Compound shown to be safe and well-tolerated with a dose-related response
- Oral delivery often preferred among patients, increasing adherence to treatment
- Additional studies planned in moderate-to-severe psoriasis and eczema

BEVERLY, MA–(Marketwired – May 24, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to inform shareholders that topline data from the Company’s Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis.

Study Background

Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.

For more information comparing the IGA and the PASI psoriasis scoring systems, please see the link immediately below. Two additional links have been provided summarizing recent dermatological studies by Regeneron and Anacor that used the IGA scale.

            http://www.ncbi.nlm.nih.gov/pubmed/24354461

            http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=963078

            http://investor.anacor.com/releasedetail.cfm?releaseid=921668

Entry criteria for the study required: a total Body Surface Area (BSA) affected by plaque psoriasis of 10 percent to 20 percent; a baseline IGA score of 2 (“mild”) or 3 (“moderate”); and the identification of a target psoriatic lesion with a score greater than or equal to 3 based on a different (than the IGA) lesion-specific 5-point scoring scale. Clinical signs that psoriasis is clearing typically are more noticeable in patients with a greater severity of symptoms. This translated into a rigorous and aggressive study design for the Prurisol trial.

The primary endpoint assessed was the percentage of patients achieving at least a 2-point improvement from baseline on the IGA 5-point scale as measured by visual inspection of patient lesions at the end of the 84-day (12-week) treatment period. In effect, given the entry criteria, participants had to at least obtain an IGA score of “clear” or “almost clear” skin, dropping to 0 or 1 after starting from a baseline of 2 or 3. Secondary endpoints included additional improvement measures tied to degree of patient response at various time intervals.

Results Summary

The Phase 2 Prurisol trial, while not powered to demonstrate statistical significance, was conducted to inform any future fully-powered Phase 3 trial(s) that might be merited. As a result, the study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.

Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.

Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.

            http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/

For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.

            http://investor.anacor.com/releasedetail.cfm?releaseid=587511

Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.

Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional.