Tests of a non-steroid therapy for plaque psoriasis went well, drug-development startup Dermipsor says.
Psoriasis is incurable: Dermipsor's drug, DPS-101, is designed to alleviate the symptoms, explains CEO Zeev Even-Chen. "Steroids have a whole list of side effects in the short and long run," he said. "There is one other non-steroid drug based on vitamin D, but its efficacy is low," he added. "Our product's efficiency is of the same amplitude as a steroid drug."
The Phase IIb test of DPS-101 was carried out over 12 weeks in several centers in Europe, and looked at a range of doses. It demonstrated statistically significant efficacy, Dermipsor says. The Rehovot-based startup, founded in 2004, expects to initiate a Phase 3 study in 2009, it says.
The drug was applied to 168 people - but treated each side of their body separately, so, as Dermipsor points out, it effectively had 336 test subjects.
Its goal was to evaluate the effectiveness of a range of different doses of nicotinamide, combined with a fixed concentration of calcipotriol, the two active ingredients.
Analysis of the results showed that half the patients receiving the highest dose of DPS-101 achieved a state of "clear to almost clear" at the end of the 12-week study, Dermipsor says.
It also found that high-doses of DPS-101 showed statistically significant efficacy relative to placebo.
The market for topical psoriasis treatments is worth more than a billion dollars a year, the company says: The condition affects between 2%-3% of the world's population.
Originally Dermipsor hoped its drug would reach the market in 2011. Now, given the meltdown of the financial systems, the launch will probably be delayed by a year, says Even-Chen.
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