The PanACEA Executive group has returned to Amsterdam on the 26th of September to meet with representatives from South Africa, Tanzania, the UK, Germany and the Netherlands. PanACEA II has started its first trial, HIGHRIF, and is moving towards the phase IIA study; an excellent moment to discuss the latest developments in a face-to-face meeting.
In September HIGHRIF continued recruitment in Cape Town, South Africa. Previously we evaluated doses up to 40 mg/kg, and currently we are assessing the safety and efficacy profile of a 50 mg/kg dosage. First results can be expected early next year.
Furthermore, we talked extensively about the set-up and conduct of our upcoming trials. More specifically, we discussed what kind of efficacy, safety, and pharmacokinetic data from a phase IIa study could best feed the dose selection and study design of PanACEA’s STEP IIc trial, omitting the need of an intermediate phase IIb trial.