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Obesity Co. Harkness Awaits Fate Following Clinical
Trial
VentureWire
By Brian Gormley
Thursday, September 6, 2007
Harkness Pharmaceuticals Inc., a virtual company bankrolled by
Sanderling Ventures to develop an appetite-suppressing treatment
for obesity, has completed a Phase I/II clinical trial that will
determine its fate.
The San Diego company, which has raised $5 million from Sanderling
since forming in 2003, the most recent a $1 million financing done
in the first quarter, completed dosing last month and expects to
have data by year's end, said Sanderling Principal Peter C.M. McWilliams,
a member of the Harkness board.
After seeing results, Harkness will choose from among several options,
which include building up further, licensing out its lead compound
and selling the company. Managing Director Timothy J. Wollaeger
serves as chief executive.
Harkness's lead drug candidate is enterostatin, one of several
natural agents that promote a feeling of satiety after eating. Unlike
other agents in this pathway, enterostatin can be taken orally.
The Phase I/II trial started early this year and encompassed about
20 obese but otherwise healthy adults. Though its primary endpoints
are safety and tolerability, the firm also expects the study to
yield insight into the drug's ability to suppress appetite, McWilliams
said.
Because enterostatin is natural, it is likely to be safe, McWilliams
said. In addition, there may be ways to determine which patients
are best suited to the drug, he said, though he declined to elaborate.
About a third of U.S. adults are obese, according to the 2003-2004
National Health and Nutrition Examination Survey. One benefit Sanderling
sees to Harkness's approach: medications such as Meridia, sold by
Abbott Laboratories, have proven that appetite control can work.
Meridia blocks the re-uptake of the neurotransmitters serotonin
and norepinephrine, which help regulate sense of fullness, according
to Abbott.
The market for appetite-controlling drugs is likely to grow more
competitive. Orexigen Therapeutics Inc., which went public in April
after raising capital from Scale Venture Partners, Sofinnova Ventures
Inc., Domain Associates LLC and others, is developing two such products
in late-stage trials: Contrave, now in Phase III, and Empatic, which
is in a Phase IIb trial. Each is designed to act on specific neurons
of the central nervous system to achieve appetite control and sustained
weight loss, according to Orexigen.
Medical device investors also see potential in appetite control.
In April Latterell Venture Partners led a tranched $20 million Series
C for Leptos Biomedical Inc., a Brooklyn Center, Minn., developer
of an implantable device that stimulates the sympathetic nervous
system to suppress appetite, reduce hunger and trigger the burning
of fat, for example.
Another device company, EnteroMedics Inc., of St. Paul, Minn.,
raised venture backing from MPM Capital LP and others before filing
to go public in May. EnteroMedics is developing an implantable device
that uses high-frequency, low-energy electrical impulses to intermittently
block the vagus nerve, which controls much of the activity of the
stomach, intestines and pancreas, and plays a role in food processing.
EnteroMedics's Maestro system, which uses this vagus-blocking approach,
is designed to limit stomach expansion, reduce frequency of stomach
contractions and produce a feeling of early and prolonged fullness,
according to information in its registration statement.

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