Study demonstrates that the new capsule improves drug levels of lead antiviral
drug BIT225 by over 160%
Capsule formulation to be used in Phase 2b HCV trial 2H 2013
Biotron Limited (ASX: BIT) has successfully developed a capsule formulation of its lead HCV and
HIV drug candidate BIT225.
A Phase 1 study of the new formulation, developed in collaboration with a specialist US formulation
company, has demonstrated that the capsule administered drug is associated with reproducible
absorption and a relative bioavailability more than 1.6 times greater than the previous powder
formulation.
Biotron Managing Director Dr Michelle Miller said the new capsule formulation has the potential to
further enhance the already positive safety profile of BIT225, and will facilitate extended trials in
larger patient populations.
"In essence, this trial has demonstrated we can use lower doses of BIT225 to achieve higher blood
levels of the compound in patients safely and efficiently," she said.
"This is an important milestone as we progress commercialisation of this first in class drug. These
results bolster BIT225’s overall data package and increase its appeal to potential licensing partners."
The single-dose, two phase, cross-over study in healthy volunteers was conducted at an Australian
clinical trial site. Fourteen participants were randomised to receive 400 mg of BIT225 as a single
dose of either the new capsule or the existing powder formulation. They were then subject to
extensive blood sampling over a 96 hour period.
Two weeks later, participants received the alternate formulation and further blood samples were
taken over the same period.
Bioanalysis of these samples demonstrated that blood levels of BIT225 were more than 1.6 times
higher following capsule delivery. This means that in future trials, lower doses of drug can be
delivered by capsule than have been used in previous trials.
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