Experimental HIV Drugs Safety Monitoring Board Says Phase 3 Trial of Experimental NRTI Apricitabine Can Go Forward Using Lower Dose
Safety Monitoring Board Says Phase 3 Trial of Experimental NRTI Apricitabine Can Go Forward Using Lower Dose
- Details
- Category: Experimental HIV Drugs
- Published on Tuesday, 16 June 2009 14:12
- Written by Liz Highleyman
A Data and Safety Monitoring Board (DSMB) has approved the continuation of a Phase 3 clinical trial of the experimental nucleoside reverse transcriptase inhibitor (NRTI) apricitabine, according to Avexa Limited, the company developing the drug.
Earlier this year, Avexa reported promising 96-week findings from a Phase 2b study of apricitabine, showing good HIV suppression with no drug-related adverse events.
The recent announcement does not indicate exactly why higher doses of apricitabine were dropped, but this often suggests safety concerns. The company did indicate that the lower dose is better suited for fixed-dose combination pills, which appear to be future direction of combination antiretroviral therapy.
Below is an excerpt from the Avexa press release describing the DSMB findings.
- DSMB recommends continuation of the ATC Phase III Trial after review of the data
- Lower, 800 mg dose selected to use going forward
- 800 mg dose more conducive to fixed dose combinations
Melbourne, Australia -- June 4, 2009 -- Avexa Limited (ASX:AVX) announced that the Data Safety Monitoring Board (DSMB) met today to review the 16 week data from Avexa's apricitabine (ATC) Phase III clinical trial. The DSMB reviewed the data and recommended continuation of the study with the 800 mg dose. Patients taking the 1200 mg dose will be transitioned to the optimum 800 mg dose to continue their therapy.
"We are delighted with the recommendation by the DSMB for the continuation of the Phase III trial," said Dr. Julian Chick, Avexa's Chief Executive Officer. "The 800 mg dose is considerably easier to formulate into fixed dose combinations, thus increasing the commercial potential for ATC. Given ATC's excellent safety and activity profile, these results allow us to move forward with increased confidence in ATC as a treatment option for HIV patients."
Avexa's Phase III trial compares ATC to 3TC [lamivudine; Epivir] in drug-resistant HIV patients. The 16 Week component had three arms comparing doses of ATC at 800 mg and 1200 mg to the 3TC control arm. A minimum of 50 patients were enrolled in each arm. In all three arms, patients received either ATC or 3TC as part of an optimized background regimen. The trial will continue with two arms comparing the 800 mg ATC dose to 3TC. The Phase III trial is being conducted with more than 130 sites worldwide.
Patients from the earlier Phase IIb study, which used the 800 mg ATC dose, have been successfully treated with ATC for up to three years. This provides further evidence of the safety, efficacy, and durability of 800 mg ATC for the treatment of HIV.
About Apricitabine (ATC)
Apricitabine (ATC) is an anti-HIV nucleoside reverse transcriptase inhibitor. ATC is Avexa's lead program and has successfully completed the 96 week dosing of its Phase IIb clinical trial and commenced its Phase III trials worldwide in January 2008 in HIV patients with NRTI resistance. In clinical trials to date, ATC has shown the following characteristics: a unique resistance profile over 96 weeks of treatment, continued efficacy beyond two years of treatment, an excellent safety profile, and an ongoing immunological benefit. Dr Jonathan Coates, Avexa's Chief Scientific Officer, is a former Project Leader for multiple anti-viral programs at GlaxoSmithKline and a co-inventor of anti-viral drug 3TC, one of the best selling anti-HIV drugs in history with over USD $8 billion in global sales to date. ATC targets a current unmet medical need that has earned the compound Fast Track status with the U.S. Food and Drug Administration.
About the Data Safety Monitoring Board (DSMB)
The Data Safety Monitoring Board (DSMB) for Avexa is a group of international experts that reviews, on a regular basis, accumulating data from ATC's ongoing Phase 3 clinical trial. The DSMB advises Avexa regarding the continuing safety of trial subjects, as well as the continuing validity and scientific merit of the trial.
6/16/09
Source
Avexa, Ltd. Positive Outcome Reached at 16 Weeks for Avexa's ATC Phase III Trial. Press release. June 4, 2009.
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