Exacerbation management

Why anti-inflammatories for cystic fibrosis need a new regulatory endpoint

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1.

The company is developing lenabasum, a synthetic cannabinoid receptor 2 (CB2; CNR2) agonist that acts as an anti-inflammatory agent. CB2 activation inhibits proinflammatory cytokine generation, suppresses leukocyte trafficking and stimulates synthesis of anti-inflammatory molecule lipoxin A4 (LXA4).

After a Phase II safety study showed the candidate did not improve forced expiratory volume over one second (FEV1) but did reduce the frequency of pulmonary exacerbations, the Cystic Fibrosis Foundation (CFF) suggested Corbus move forward with a larger study measuring exacerbations as the primary endpoint.

CFF has been advising the biotech and provided funding for both studies. During the time Corbus was running its Phase II study, an anti-inflammatory working group led by CFF had determined that exacerbations is the endpoint best suited for evaluating these candidates.

FEV1 is a direct measure of lung function and is the endpoint used for approved drugs. While inflammation

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