Solbec psoriasis trial disappoints

By Graeme O'Neill
Wednesday, 30 March, 2005

Preliminary data from Solbec Pharmaceuticals' (ASX:SBP) Phase I/IIa clinical trial of its anti-psoriasis developmental drug Coramsine have confirmed that it is safe and well tolerated, but have not indicated any superiority to existing commercial treatments for psoriasis.

The Perth drug-discovery company's business development manager, Greg Barrington, said today the $1.7 million trial of the Coramsine cream formulation had met its primary endpoints, including indications of efficacy in human volunteers.

"The trial was not powered to demonstrate efficacy, and while we had some indication of efficacy, we would have liked to have had better results," Barrington said. "The results did not replicate what we saw in our initial proof-of-concept trial".

Coramsine - formerly known as SBP002 - had previously shown promising anti-inflammatory and anti-cancer activity in pre-clinical tests.

In January last year Solbec reported that SBP002 appeared to have systemic activity against psoriasis, after several AIDS and cancer patients treated with the drug as a last-resort therapy reported rapid, complete resolution of chronic psoriasis, a disorder that results in scaly, inflamed skin. The patients regrew healthy, pink skin within 30 days.

Asked whether the problem lay with the cream formulation or the drug itself, Barrington said the answer would not be clear until the company received a full analysis of the trial in psoriasis patients in about six weeks' time.

"We really can't draw any conclusions yet, but the Board felt it had to make an announcement because these preliminary results constitute material information for investors."

The company said it would need to do more work on the formulation before moving to larger phase II trials.

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