Corbus Pharmaceuticals has secured a development award of up to $25m from Cystic Fibrosis Foundation to support its Phase llb study of lenabasum to treat people with cystic fibrosis (CF).
The multicentre, double-blinded, randomised, placebo-controlled trial will enrol 415 people with CF who are at least 12 years of age and at increased risk for pulmonary exacerbations (PEx), which are severe inflammatory events from the condition.
The six-month trial’s primary efficacy endpoint includes the event rate of pulmonary exacerbations.
Its secondary efficacy outcomes feature other measures of pulmonary exacerbations, change in cystic fibrosis questionnaire-revised respiratory domain score and change in forced expiratory volume in one second (FEV1).
The trial will be carried out in around 100 sites across North America, Europe, Israel and Australia. Patients will be centrally randomised to one of three cohorts to either receive lenabasum 20mg twice a day, lenabasum 5mg twice a day, or placebo twice a day for 28 weeks, with four weeks follow-up off active treatment.
Study co-principal investigator James Chmiel said: “People with CF and their physicians understand the need to reduce pulmonary exacerbations, a major driver of disease burden.
“New treatments are essential, given most adolescent and adult patients have at least one episode per year.
“Lenabasum showed promising efficacy against pulmonary exacerbations in a previous 85-subject Phase II study and we look forward to getting a more definitive answer about lenabasum’s beneficial impact on reducing pulmonary exacerbations in high-risk patients in the upcoming study.”
The Phase llb CF study trial expects to start dosing patients in this quarter and is expected to be completed by the end of next year.