Corbus Pharma outlines US approval path for lead drug
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 said.
Corbus said 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 drug's approval.
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 trading.
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 immuno-suppression.
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 The Street columnist Adam Feuerstein accused Corbus of "cherry-picking" trial data to mislead investors, allegations that Cohen vehemently denied in an interview with Reuters.
Cohen however said he expects Corbus would have to conduct multiple studies on anabasum in CF patients before applying for approval.