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 Corbus, a tiny biopharmaceutical company, received $5 million from
the Cystic Fibrosis Foundation last month to develop the drug,
Resunab, and expects to begin a mid-stage study this quarter.
The company hopes Resunab will treat every patient suffering from
the disease, compared with Kalydeco, which has approval to treat a
small section of patients. The disease currently affects 70,000
people worldwide.
Kalydeco treats certain underlying genetic mutations behind cystic
fibrosis (CF), while Resunab aims to manage the inflammation the
disease causes.
"We're not focusing on a particular subset of patients, like
Vertex's drug," Chief Executive Yuval Cohen said.
Kalydeco, which was granted fast-track status by the U.S. Food and
Drug Administration, received approval in 2012, six years after the
company started an early stage trial.
Kalydeco, which had sales of about $464 million in 2014, is being
tested in combination with other drugs to expand its use.
It is expected to generate peak sales of $1.1 billion in 2020,
according to Thomson Reuters Cortellis.
Resunab could bring in more than $2 billion in U.S. sales treating
CF patients, Zacks Investment Research analyst Jason Napodano said.
Still, Corbus has a long way to go.
"It's too soon to know how significant Resunab will be ...," said a
CF Foundation spokeswoman.
CF is caused by a missing or defective gene that makes the body
produce a thick, sticky mucus resulting in inflammation and
bacterial infections.
This then causes "abnormal inflammation," which leads to fibrosis,
and, eventually, death.
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"Theoretically, we're targeting all CF patients, because the one
thing that all these mutations share is that every single one of
them exhibits abnormal inflammation," Cohen said.
Cohen had helped develop five anti-inflammatory drug candidates as
co-founder of Celsus Therapeutics Plc.
Since Resunab aims to bring down the abnormal inflammation by
mimicking a natural process, Cohen expects it will have a "good
safety profile". Existing anti-inflammatory drugs are typically
associated with serious side-effects and suppress the immune system.
Resunab is also being tested to treat scleroderma, an inflammatory
skin disorder. A scleroderma approval could add another $2 billion
in peak sales, Zacks' Napodano said.
Shares of the company, which has a market value of about $80
million, traded over the counter before listing on the Nasdaq in
April.
(Editing by Sayantani Ghosh and Sriraj Kalluvila)
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