Halcygen completes first pivotal SUBA-itraconaole trial

Melbourne, Australia-based HalcyGen Pharmaceuticals says it has successfully completed the first of three pivotal pharmacokinetic studies scheduled under its Investigational New Drug application recently approved by the US Food and Drug Administration. The study has demonstrated that SUBA-itraconazole in a "half-dose" format gives comparable pharmacokinetic levels to Sporanox (itraconazole).

The registration strategy for SUBA-itraconazole is designed to compare HalcyGen's product with the market's leading brand Sporanox. HalcyGen's chief executive, Roger Aston, said: "this is a very pleasing result from our first clinical trial, our SUBA-itraconazole shows promise as a half-dose alternative to the higher dose Sporanox. We expect to have all three pharmacokinetic studies completed by Christmas prior to seeking further guidance from the FDA."

HalcyGen has clinically evaluated SUBA-itraconazole, a patented formulation, in five successful pharmacokinetic studies in Australia. These have demonstrated that it has significantly improved bioavailability (absorption by the gastrointestinal tract) compared with the market leader, enabling the use of a lower dose of the drug. HalcyGen's formulation also provides for more stable blood levels compared to Sporanox.