Irish-based gastro-intestinal drugs development firm AGI Therapeutics hailed positive results in a phase II proof of concept study of a new product designed to ease the side effects of cancer chemotherapy.
The company said it had positive results from a Phase II proof of concept study for AGI-004 in the control of chemotherapy-induced diarrhoea (CID). AGI-004 is a once-daily controlled release transdermal patch which contains contains the nicotinic antagonist mecamylamine.
The phase II study was conducted in 64 patients across seven sites in Europe and evaluated two doses of AGI-004 compared to placebo.
The results showed a statistically significant difference in the primary endpoint of reducing the incidence of patient-recorded diarrhoea. Non-significant benefit in the primary endpoint was also observed with the lower dose and, when diarrhoea was rated by the physician using the National Cancer Institute (NCI) grading system, both doses demonstrated positive improvements. Similarly, positive trends were also observed for the higher dose in the co-primary endpoint of reducing the number of bowel movements per day.
AGI-004 treatment was well tolerated across both doses and there were no drug-related serious adverse events, the company said.
"We are pleased with the outcome of this study which we believe supports the continued development of AGI-004 as a novel anti-diarrhoeal agent," said Dr John Devane, CEO of AGI Therapeutics.
"Although designed as an exploratory study, we observed a strong signal of efficacy for AGI-004 across multiple measurements of diarrhoea, in particular with the higher dose used in the study. The development of AGI-004 in a convenient transdermal patch, which can reduce the occurrence of diarrhoea in chemotherapy patients, offers a significant therapeutic advantage over current standard of care," he added.
