Encouraging Ph IIa data for Alizyme's ALT-104

Cambridge, UK-based drugmaker Alizyme has reported encouraging preliminary results from a Phase IIa clinical trial of ATL-104, its treatment candidate for mucositis.

The multicenter, randomized, double-blind, placebo-controlled, 64-patient trial is a pilot proof-of-concept study, was designed to determine the effect of ATL-104, administered as a swallowable mouth wash, on a number of parameters associated with chemotherapy-induced mucositis, including duration, as well as safety and tolerability.

The duration of the condition was consistently reduced across all actively-treated groups. World Health Organization grade 2-4 mucositis patients on ATL-104 showed a shorter mean duration across all doses of the agent (50mg/day, 100mg/day, 150mg/day, at 3.5, 4.5, 3.2 days, respectively) compared to placebo (5.9 days). In those with grade 3 or 4 severity, the mean was 2.4, 2.8, 3.1 days for the ATL-104 groups, and 5.4 days for placebo. The duration of oral ulceration and pain was also lower compared to placebo, across all three dosages, as was the number of days when a patient was unable to take solids by mouth.