Corbus Takes On New Cystic Fibrosis Endpoint With Lenabasum
The US FDA has agreed to Corbus' plan to use pulmonary exacerbations as the only primary endpoint in a new large Phase II study, which is powered to serve as a registrational study.
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Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.