Gets a Second Chance
Avexa announced that has reached an agreement with
the FDA to complete testing of its experimental
is an experimental nucleoside reverse transcriptase inhibitor
(NRTI) that has shown generally good safety and efficacy in
clinical trials to date. But it has not been able to demonstrate
better performance than other highly effective drugs on the
market, and it may require too high a dose to be taken once-daily
or included in coformulations to reduce pill burden.
2009 Avexa halted a Phase 3 study of apricitabine ahead of
schedule, and in May 2010 it announced it would end
development of the drug after failing to find a partner
with the resources to complete the clinical trials process.
last week the company announced that it has reached an agreement
with the U.S. Food and Drug Administration (FDA) about a regulatory
pathway to final approval.
is an edited excerpt from an Avexa press release describing
the recent developments.
and FDA Agree on Path Forward for Apricitabine
Australia -- Monday 28th March, 2011 -- Australian biotechnology
company Avexa Limited (ASX:AVX) today announced that it has
successfully completed a comprehensive and highly productive
meeting with the U.S. Food and Drug Administration (FDA) in
which the remaining regulatory pathway to final approval for
the company's key anti-HIV drug apricitabine (ATC) has been
Most importantly, the FDA has recognized and given credit
for the significant amount of previous ATC clinical studies
conducted by Avexa, in particular the latest ATC study AVX-301.
As a consequence, the remaining regulatory requirements for
an ATC approval are considerably less complicated and less
extensive than previously assumed and less than that required
for other recently approved drugs.
In summary Avexa can now expect:
simpler, and faster regulatory path forward to approval;
"risk of failure" mitigation;
less cost resulting in better economics for ATC;
immediate Phase III [trial] with near term approval
to be far more attractive economically to potential
Initially ATC will be developed for HIV patients who have
developed resistance to multi-drug therapy. ATC has shown
great potential as a therapy in the fight against multi-drug
resistant HIV. As a twice-a-day dosed drug, ATC, with its
recognized excellent safety profile, complements the new generation
of anti-HIV drugs such as Isentress [raltegravir], Merck's
HIV integrase inhibitor, which are also dosed twice daily.
As a novel nucleoside, a class which is well known to be a
vital component of anti-HIV therapy, ATC offers a new extension
to existing therapies in the treatment of HIV especially for
those patients with limited remaining therapeutic options.
"The meeting with the FDA has provided a clear and expeditious
regulatory pathway for ATC. This is a significant milestone
for Avexa and its shareholders," said Dr Jonathan Coates,
Interim CEO. "We can now plan the next regulatory steps
for the program with confidence and secure the commercialization
of this very valuable anti-HIV drug."
Limited is a Melbourne-based biotechnology company with
a focus on discovery, development and commercialization
of small molecules for the treatment of infectious diseases.
Avexa's key projects include apricitabine (ATC) for the
treatment of drug-resistant HIV, an HIV integrase program
and an antibiotic program for antibiotic-resistant bacterial
infections. For more information, visit www.avexa.com.au.
Limited. Avexa and FDA Agree on Path Forward for Apricitabine.
Press release. March 28, 2011.