Antisense psoriasis cream to undergo clincial study

Antisense Therapeutics has announced plans to conduct a pre-Phase I proof-of-concept clinical study to confirm that its antisense psoriasis treatment ATL1101 shows activity.

The company has developed a topical cream containing ATL1101, which has been demonstrated in laboratory studies to penetrate human psoriasis skin biopsies and silence the target gene insulin-like growth factor-1 receptor (IGF-1r).

According to Antisense development director Dr Jega Iswaran, there is no animal model for psoriasis making it difficult to test for therapeutic activity. The proposed proof -of-concept study, known as a Small Plaque Assay (SPA), would allow the company to assess whether ATL1101 showed adequate penetration of psoriatic lesions and knockdown of the target gene under tightly controlled conditions in a limited number of patients.

The study would not be used to demonstrate efficacy, Iswaran said.

Positive results would provide Antisense with increased confidence in the prospects for successful commercial development of the drug and would boost opportunities for early partnering and investment in the project.

But before the study can take place, the company has to finish the pre-clinical development, including manufacturing and formulation as well as formal toxicology studies. The manufacturer of ATL1101 has been selected, according to the announcement, as has a contract research organisation to conduct the SPA study.

Iswaran said pre-clinical development would be completed in the first half of next year, and after approval, the SPA study would be likely to start mid-2004, with results from the short term study expected toward the end of 2004. Antisense received a AUD$1.1 million R&D Start grant earlier this year to develop the psoriasis treatment.

The company's share price (ASX: ANP) rose by almost 10 per cent to AUD$0.115 on Thursday after the announcement.