Immtech Announces Results of DB289 Formulation Trial
Immtech International has announced the results of the safety trial comparing three different formulations of DB289, the company's first oral drug candidate.
One of the tablet formulations has been selected for use in the pivotal Phase III studies in Trypanosomiasis and Pneumocystis pneumonia (PCP), as well as for commercialization. The study's objective was to compare the bioavailability of the current capsule formulation to two new formulations in pressed tablets.
The results showed that the pressed tablets produced similar blood concentrations when compared to the capsule formulation and that the tablet formulations yielded more consistent blood levels of the active drug that is formed in the body from DB289. The study, conducted in in 42 healthy volunteers, required each volunteer to take a single oral dose of DB289 in each of the three formulations, with a seven-day period between each dose. Blood was collected at regular intervals from each volunteer to determine the level of DB289 in the blood.
The advantage of the pressed tablet is that it is less expensive to manufacture and more stable in conditions with high temperatures and humidity, such as those found in certain countries in sub-Sahara Africa, South America and Asia.