(Adds details, CEO comment, shares)
By Natalie Grover
April 5 The U.S. Food and Drug Administration
needs Corbus Pharmaceuticals to show positive data from
only one late-stage study on its experimental treatment for
scleroderma to support a marketing application, the company
Corbus said on Wednesday it expects to start the study on
270 patients in the fourth quarter and that it was in talks with
the European health regulator to wrangle a similar deal for the
The earliest the drug, anabasum, could win U.S. approval to
treat scleroderma is in the latter half of 2020, if all went
well, Chief Executive Yuval Cohen told Reuters.
The company's stock rose about 3.7 percent to $8.35 in early
Scleroderma comes from the Greek words for "hard skin" and
mostly affects women. It is a chronic, rheumatic disease that
affects about 90,000 people in the United States and Europe.
Anabasum aims to mimic a natural process to "turn off"
chronic inflammation and scarring, without causing
The drug is also being tested to treat other inflammatory
disorders, including cystic fibrosis (CF) and lupus.
Corbus last week announced positive data from a study
testing anabasum's safety and tolerability as an add-on therapy
for CF, a genetic disorder characterized by a progressive loss
of lung function.
The company said the results showed anabasum has an
acceptable safety profile and potential clinical benefit in
reducing acute pulmonary exacerbations.
However, noted TheStreet columnist Adam Feuerstein accused
Corbus of "cherry-picking" trial data to mislead investors,
allegations that Cohen vehemently denied in an interview with
Reuters on Wednesday. (bit.ly/2o2fQO2)
Cohen however said he expects Corbus would have to conduct
multiple studies on anabasum in CF patients before applying for
(Reporting by Natalie Grover in Bengaluru; Editing by Martina
D'Couto and Savio D'Souza)