| |
|
|
BIOWORLD
TODAY– OCTOBER
5, 2007
APT Targeting Lung
Transplant, Disease With $22M Financing
By Jennifer Boggs
APT Pharmaceuticals Inc., which secured
rights to a late-stage, orphan product for lung transplant
rejection from Novartis AG earlier this year, is ramping
up for a large Phase III study next year, thanks to $22 million
private financing.
The company's Series A-2 round
was led by Menlo Park, Calif.-based Versant Ventures and
Greenwich, Conn.-based Great Point Partners and included
existing investors Vivo Ventures and Charter Life Sciences,
both of Palo Alto. To date, APT has pulled in about $30 million
to support its strategy of "low-risk drug development," while
creating products for areas of unmet need, such as lung transplant
rejection and lung diseases, said Stephen Dilly, president
and CEO.
"There's
a very small number of clinical centers [that conduct] lung
transplants," he told BioWorld Today, "and those
centers also treat diseases that lead to lung transplants.
So our business plan is to really focus on that niche market
and develop multiple molecules for that market."
To
that end, APT picked up rights in May to Pulminiq, an inhaled
cyclosporine aimed at increasing survival and preventing
chronic rejection in combination with standard immunosuppressive
therapy following lung transplant. That product previously
had been in the hands of Emeryville, Calif.-based Chiron
Corp., where Dilly had served as chief medical officer -
two other AP T executives, Chief Operating Officer Howie
Raff and Gregory Baigent, vice president of its pulmonary
transplant program, also are Chiron alums - until Novartis
reacquired the program in 2006 through its $5 billion buy-out
of Chiron. While part of Chiron's development program, Pulminiq
was deemed approvable by the FDA, though the agency requested
additional clinical efficacy data.
Between the familiarity with the product
and the FDA's requirements contained in the approvable letter, "we
know exactly what we need to do" to get Pulminiq across
the finish line, Dilly said. "We're preparing to go
into our Phase III study in the first quarter of 2008." That
study is expected to involve several hundred newly transplanted
patients and will compare Pulminiq to placebo, with patients
in both groups also receiving best standard of care. Data
is anticipated in a "three-
to four-year time horizon," and pending success, APT
expects the drug "to reach market fairly
soon after that," he added.
Money from the Series A-2
round should "comfortably
sustain us for two years," Dilly said, and, by that
time, the Pulminiq trial is expected to be fully enrolled,
or close to it, and APT hopes to have data for its inhaled
antibiotic program. In short, the firm was "trying
to build a big enough war chest to take our assets through
a value infection before we go out to raise more money."
APT
aims to build a pipeline of repositioned drugs, including
molecules that have gained approval outside the U.S. The
company also is looking to move existing molecules into inhalable
formulations and looking for new indications for approved
drugs. Part of its approach includes taking existing antibiotics,
which are administered either intravenously or orally, and
reformulate them to be administered directly into the lungs
for treating strains of bacteria in diseases such as cystic
fibrosis and bronchiectasis and in lung transplants patients.
Those should "follow on nicely behind Pulminiq," Dilly
said. He added that clinical efficacy data from those programs
are expected in 12 to 18 months.
Along with the financing,
APT named Camille Samuels, of Versant Ventures, and David
Kroin, of Great Point Partners to its board. The company
also recently appointed Ralph Niven chief technology officer.
|
|
