Solbec wins ethics approval for psoriasis trial

The Royal Adelaide Hospital’s human ethics committee has approved an application by Perth biotech Solbec Pharmaceuticals (ASX:SBP) to conduct a Phase I clinical trial of the company’s lead anti-cancer compound, SBP002, as a potential treatment for the painful skin disorder psoriasis.

The company will begin enrolling its first psoriasis patients in the trial early next month – the trial is being run by Adelaide-based clinical trials specialist CMAX, the clinical division of IDT Australia.

The trial will test whether a skin-cream formulation of SBP002 is safe and well tolerated.

The same compound – a mixture of two alkaloids from the prickly weed Solanum linneaum – has shown high promise as an anti-tumour agent in a number of cancer patients with late-stage sarcoma, mesothelioma, melanoma, and breast cancer.

Research has shown that, in addition to killing cancerous cells, SBP002 blocks the inflammatory activity of the cytokine interleukin-6, which is known to have a role in auto-immune disorders like psoriasis.

The company said it has manufactured the skin cream and placebo for the three-phase psoriasis trial. The first phase will involve a one-day treatment for healthy volunteers, to test the drug’s tolerability, followed by another five-day trial, again in healthy volunteers.

The third phase will be a 56-day trial in volunteer patients with mild to moderate psoriasis. Their responses will be compared with those of two control groups – one on a placebo treatment, the other on a standard psoriasis drug.

Between 3 and 5 per cent of the population suffers mild to severe psoriasis, and the potential global market for a new and effective therapy has been estimated at $3 to $6 billion.