DRUG DEVELOPMENT group AGI Therapeutics expects to have top-line data on its key irritable bowel syndrome (IBS) therapy by the end of June.
Company chief executive John Devane acknowledges that the company’s immediate future will be determined by the initial results of the Phase III trial of the efficacy of the drug, Rezular, in treating patients with a diarrhoea-predominant form of the condition.
A positive result would see the company securing a partner for the further development and manufacture of the drug on a commercial basis. Dr Devane said the company had concentrated its financial resources last year on its “more advanced programmes” , particularly Rezular as uncertainties in the markets “restrict the ability of development-stage companies such as ours to access further funds at a price acceptable to existing shareholders”.
“We never expected to find ourselves in this market when we decided to fund the Phase III programme ourselves,” Dr Devane said yesterday, although he insisted that the company had sufficient reserves to fund its operations for the next 12 to 18 months.
AGI yesterday reported full-year figures for 2008 that showed reduced losses of $18.2 million compared with $20.7 million in 2007 on flat turnover of $577,000.
The companies cash and short-term deposits fell to $23.6 million from $45.5 million a year previously while spending on research and development was reduced to $15.9 million compared to $19.4 million in 2007. The loss per share was 27 cents compared with 30.7 cents in the earlier period.
Rezular is the first drug brought to Phase III by AGI, which specialises in developing therapies for gastrointestinal illnesses.
“We believe we have the ability to introduce the first new therapy for the treatment of IBS-D in the US in almost 10 years,” said Dr Devane, citing significant unmet medical need.
Aside from the Phase III efficacy trial, the company yesterday announced that it had concluded enrolment for a separate follow-on safety trial of the drug. AGI expects to have figures from this trial in the first quarter of 2010.
AGI Therapeutics
Turnover:$577,000 (+0%)
Profit/Loss:-$18.2 million
EPS:-27 cent
