The Cystic Fibrosis Foundation has awarded Corbus Pharmaceuticals up to $25 million to develop a potential anti-inflammatory drug that aims to reduce the frequency of pulmonary exacerbations for people with CF.
The synthetic drug lenabasum (formerly known as anabasum) showed encouraging results in an earlier, smaller Phase 2 trial, demonstrating that it reduced signs of inflammation, including inflammatory cells and mediators (chemicals that trigger an exaggerated immune response) in individuals with CF. In addition, the drug does not appear to suppress the body's natural immune response, a problem that has arisen with other potential anti-inflammatories.
The funding will enable Corbus to proceed with a second, larger Phase 2 study of the drug to determine whether it reduces the number of pulmonary exacerbations, a sudden worsening of respiratory symptoms that often requires intravenous (IV) antibiotic treatment in people with CF. In the previous Phase 2 trial, the data indicated that treatment with lenabasum was associated with a decreased proportion of participants with pulmonary exacerbations compared to placebo. Lenabasum also delayed the onset of the first exacerbation for some participants during the trial.
Reducing exacerbations in CF is important because they can cause permanent lung damage and decrease lung function, increasing the risk of dying. People with CF experience this sudden worsening of symptoms because they have an exaggerated immune response to infections, which causes excessive inflammation that not only kills the germs causing the infection, but also healthy lung tissue. The goal of lenabasum is to help the body resolve the immune system response before permanent lung damage can occur.
Because of the detrimental role inflammation plays in CF, the Foundation is committed to supporting the development of new anti-inflammatories and new anti-infectives -- therapies that can help all people with CF regardless of their type of mutation.
Corbus plans to enroll approximately 415 people with CF ages 12 and older who have an increased risk of exacerbations. The study is open to patients on CFTR modulators, including individuals currently on ivacaftor (Kalydeco®) or ivacaftor/lumacaftor (Orkambi®). The Foundation previously awarded Corbus $5 million to complete an earlier clinical trial in CF.