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12-04-2008, 04:10 PM
Non- Steroidal Combination Drug To Treat Psoriasis - Positive Phase 2b Results Showing Efficacy And Synergy DPS-101




Dermipsor Ltd, a leading clinical-stage drug development company focusing on novel therapies for the dermatology market, reports detailed analysis of the Phase 2b clinical trial results for its lead product DPS-101 in psoriasis patients. DPS-101 is a novel topical non-steroidal combination of 2 active ingredients - calcipotriol and nicotinamide - for the treatment of plaque psoriasis.

The Phase 2b dose-ranging study was a randomized, double-blind, placebo-controlled, 12 week, 7 arm study, conducted in several centers in Europe. The study included 168 bilateral patients in which each side of their body was treated separately, so that the total number of "test subjects" was 336. The goal was to evaluate the efficacy of various doses of DPS-101 (calcipotriol concentration fixed at 0.005%, nicotinamide concentration varying from 0.05% to 1.4%)

The detailed analysis of the results show that 50% of patients receiving the highest dose of DPS-101 achieved a state of "clear to almost clear" at the end of the 12 week study. Furthermore, despite the small size of the groups (48 "test subjects" per group), high dose DPS-101 showed statistically significant efficacy relative to placebo (p=0.002), statistically significant efficacy relative to nicotinamide monotherapy (p=0.02), and a trend towards statistical significance vs. calcipotriol monotherapy (p=0.096).

The study results also demonstrate the synergy between DPS-101's two active ingredients, such that the net efficacy of the drug (highest dose DPS-101 at the end of the study) is in fact greater than the sum of the efficacies of its two components - calcipotriol and nicotinamide - when administered separately.

"We are very encouraged by the efficacy of our non-steroid DPS-101 topical treatment, as demonstrated by 50% of the patients that achieved a state of 'clear to almost clear' in this study. This efficacy is equivalent to the efficacy of some of the most potent steroid containing topical treatments available today for psoriasis," said Dr. Zeev Even-Chen, Dermipsor's CEO. "We are also excited by the synergistic effect of DPS-101 in psoriasis patients, which agrees with the synergy that we have seen in animal models and tissue cultures."

DPS-101 was very well tolerated at all its doses, with no serious adverse events at any treatment arm. The rate of probably drug related mild and moderate adverse events for the highest dose DPS-101 was similar to that of placebo.

Based on these results the company expects to initiate a pivotal Phase 3 study with DPS-101 in 2009.

Trial Design and Results

This dose-ranging Phase 2b clinical trial was a multicenter, double-blind, randomized, 7-arm bilateral comparison-controlled trial. Patients were treated for 12 weeks twice daily. The study was conducted across 4 European sites and included 168 bilateral patients in which each side is treated separately, so that the total number of "test subjects" was 336, i.e. 48 test subjects per treatment arm. The 7 treatment arms were: placebo, calcipotriol 0.005%, nicotinamide 1.4%, and 4 DPS-101 arms with varying doses of nicotinamide (0.05%, 0.1%, 0.7%, 1.4%) and a fixed dose of calcipotriol 0.005%. Efficacy endpoint was defined by the percent of patients achieving a state of "Clear to Almost Clear" at the end of the study as measured on the 13-point TLPSS scale.

The primary goal of this dose-ranging study was to find an optimal dose. It was not powered to demonstrate statistical significance because of the small numbers of patients and large numbers of study arms.

The final clinical report was written by two world leading experts: Prof. Mark Lebwohl, Chairman Dept of Dermatology, Mount Sinai School of Medicine, and Prof. Alice Gottlieb, Dermatologist-in-Chief, Tufts Medical Center.

Key trial findings include:

-- The highest dose of DPS-101 showed robust and statistically significant efficacy vs. placebo (p=0.002)

-- The highest dose of DPS-101 showed robust and statistically significant efficacy vs. nicotinamide monotherapy (p=0.02)

-- The highest dose of DPS-101 showed a trend towards statistically significant efficacy vs. calcipotriol monotherapy (p=0.096)

-- 50% of patients receiving the highest dose of DPS-101 reached a state of "clear to almost clear" at the end of the study

-- The efficacy of DPS-101 increased steadily from week 4 to week 12, and remained on an upward slope at the end of the 12 week study. In contrast, neutralizing the placebo response, the efficacy of both calcipotriol monotherapy and nicotinamide monotherapy reached a maximum at 6 weeks and remained at that level till the end of the study.

-- The study demonstrated the synergy of DPS-101's two components in humans. The net efficacy of highest dose DPS-101 (neutralizing placebo effect)) at the end of the study was greater than the sum of the efficacy of both monotherapies.

-- There were no noteworthy severe adverse events. The frequency of mild or moderate adverse events which were probably drug related were similar between placebo (8%) and the highest dose of DPS-101 (8%). All adverse events were mild or moderate and did not result in discontinuation of the study medication.

About Dermipsor

Dermipsor is an advanced clinical stage drug development company focusing on novel therapies for the dermatology market. The annual world market for dermatology drugs is $8.3B, forecasted to reach $10B in 2009. Dermipsor's lead product, DPS-101, is a novel non-steroidal synergistic combination topical treatment for mild to moderate Psoriasis. DPS-101 has successfully completed an FDA regulated phase IIb dose ranging study in psoriasis patients, demonstrating efficacy and excellent safety. DPS-101 is scheduled to enter a Pivotal Phase III study in 2009. DPS-101 addresses the more than $1B annual market of topical psoriasis treatments, offering a highly desirable safe and efficacious solution to the more than 100 million psoriasis patients worldwide. Dermipsor's second product, DPS-102 for the treatment of scalp psoriasis, will start Phase II clinical studies in 2008. Dermipsor' pipeline includes additional products in earlier stages of development. Dermipsor recently signed strategic drug development collaboration with VA Boston Research Institute which covers Phase 2 and Phase 3 clinical trials.

The Company was founded in 2004 by Dr. Avikam Harel and Dr. Olga Bloch. The company's CEO, Dr. Zeev Even-Chen, leads the clinical development of its pipeline. Until October 2007 the company operated in the Meytag High Tech Incubator, which is part of the Capital Point group. Dr.Oren Becker joined the company as active chairman in December 2007.

http://www.dermi-psor.com (http://www.dermi-psor.com/)