Galleon Pharmaceuticals, a leader in the development of novel medicines
to treat breathing control disorders, today announced that results from
a second Phase I clinical study of its investigational drug GAL-021
confirmed previous findings that the drug has dose-dependent effects on
respiration. The purpose of the new study was to evaluate higher doses
of GAL-021 to determine an appropriate dose range for future studies,
including an upcoming Phase I proof-of-concept study utilizing
conditions simulating post-operative patients who have impaired
respiration.
The new study evaluated a single dose of GAL-021 in 18 healthy
volunteers using higher doses of GAL-021 than the previous Phase I
trial. The placebo-controlled, double-blind, crossover study confirmed
the drug's positive effects, including improved minute ventilation (a
capacity measure of air supplied to the lungs) and decreased end-tidal
carbon dioxide levels (a measure of the effectiveness of alveolar gas
exchange), demonstrating a clear dose response on these respiratory
parameters. Side effects of the drug were generally mild to moderate. At
the highest dose in some subjects, the improved lung ventilation was
sufficient to increase in minute ventilation by more than 50% and in
parallel lower CO2 levels more than 25%.