Avexa to discuss HIV drug with FDA

Beleaguered Australian HIV drug developer Avexa announced this week that it has booked time with the FDA to discuss opportunities for its ATC (apricitibane) program.

“This meeting with the FDA marks a very important opportunity for Avexa and ATC,” said Avexa chairman Joe Baini. “We will be able to present the most recent data from our Phase II/III to the Agency and discuss possible paths forward for ATC.”

ATC is an anti-HIV nucleoside reverse transcriptase inhibitor (NRTI), which has demonstrated a number of positive clinical characteristics including 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.

Avexa’s current board succeeded in ousting its predecessors in June after they decided to discontinue the ATC program, citing lack of interest from major pharmaceutical companies as well as a number of clinical uncertainties.

This was despite the fact that ATC had also shown positive Phase III results.

In June, the AIDS Treatment Activists Coalition and European AIDS Treatment Group sent an open letter to the then board pleading that the company not axe the ATC program, stressing that the drug is one on only a handful showing promise for the treatment of the growing number of drug-resistant patients.