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Avexa completes six months of dosing in AVX754 HIV trial, prepares for phase 3 studies
By E. Janene Geiss
Philadelphia, March 15 - Avexa Ltd. said Wednesday that its ongoing phase 2b trial evaluating the safety and efficacy of AVX754 to treat drug-resistant HIV infection has completed six months of dosing with no adverse events or patients withdrawing from the study.
The company also said it is ramping up preparations for phase 3 development, according to a news release.
Although recruitment of patients in the phase 2b study has been slower than anticipated, Avexa said it has implemented actions to speed enrollment and boost the clinical trial process.
In the first quarter of this year, Avexa said it doubled the number of clinical trial sites involved in the study. The company said it also has increased its clinical trial presence in Argentina to expedite recruitment.
"The slower than expected recruitment has for the most part been due to the very strict criteria set for this important investigation into the antiviral activity against drug-resistant HIV," Julian Chick, chief executive officer, said in the release.
The primary endpoint of the trial is the reduction in the amount of virus in the blood after three weeks of treatment. Avexa said it is aiming to complete enrollment by mid-year.
The company also said it is increasing phase 3 preparations, including the scale-up of manufacturing capabilities, production of sufficient quantities of the study drug and preparation of regulatory requirements needed to begin the trial.
Avexa is a Melbourne, Australia, biotechnology company with a focus on research and development of anti-infectives. The company is developing drugs for the treatment of infectious diseases.
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