Dermipsor Reports Positive Phase 2b Results Showing Efficacy and Synergy of its Leading Product DPS-101
03-Nov-2008
- Israel
Dermipsor Ltd reported 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).
According to the company, 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.
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