Ardelyx's constipation drug succeeds in late-stage trial
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[October 12, 2017] By
(Reuters) - Ardelyx Inc said a second
late-stage trial of its drug for irritable bowel syndrome with
constipation (IBS-C) met the main goal of reducing abdominal pain and
increasing bowel movement, sending its shares up sharply in extended
The company's shares, which jumped nearly 60 percent, were up 33.3
percent at $7.20 on Wednesday.
IBS-C, which affects more than 11 million in the United States, is a
type of irritable bowel syndrome in which patients experience
abdominal pain and severe constipation.
The drug developer said on Wednesday it intends to file for
marketing approval for the drug tenapanor with the U.S. Food and
Drug Administration in the second half of 2018.
The study showed abdominal pain in tenapanor-treated patients
reduced by at least 30 percent with more frequent bowel movement,
when compared to a placebo group.
The trial results come five months after the company reported data
from the first of its two late-stage studies, which failed to
Cantor Fitzgerald analyst Mara Goldstein said investors are likely
to re-evaluate tenapanor as a viable commercial drug for IBS-C after
the positive data.
The occurrence of diarrhea was 16 percent for tenapanor-treated
patients, slightly higher than the previous trial.
However, this is not high enough to make the drug commercially
unsuccessful, according to Goldstein.
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Tenapanor is likely to compete with Ironwood Pharmaceuticals Inc's
Synergy Pharmaceuticals Inc's Trulance, which was approved for
chronic idiopathic constipation in January, is also being tested in
patients with IBS-C.
"The IBS-C market, in spite of new drugs, is still underserved and
we believe tenapanor will be able to gain share," Goldstein said.
Tenapanor is also being tested as a treatment for elevated levels of
phosphorus in the blood in patients suffering from end stage renal
disease, Ardelyx said on a conference call.
(Reporting by Tamara Mathias in Bengaluru; Editing by Shounak
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