- Award will support ~415-patient, 6-month Phase 2b study designed to provide clear evidence of clinical benefit for people with CF
- Event rate of pulmonary exacerbations is sole primary efficacy endpoint of study
- Pulmonary exacerbations in CF are associated with reduced survival, lung function, and patient quality of life and increased health-care burden
- Management to host conference call and webcast today at 10:30 a.m. EST
Corbus Pharmaceuticals Holdings, Inc. (CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today that it has received a Development Award for up to $25 million from the Cystic Fibrosis Foundation. The Development Award enables the Company to execute its Phase 2b study of its novel, oral, pro-resolving drug lenabasum (formerly known as anabasum) in approximately 415 people with cystic fibrosis (“CF”) who are 12 years and older and at increased risk for pulmonary exacerbations (“PEx”). Pulmonary exacerbations are severe inflammatory events in CF which are associated with acute worsening of respiratory signs and symptoms and sometimes irreversible loss of lung function.
“We believe this award highlights the potential for lenabasum to serve as an important therapy for people living with CF by targeting a critical unmet need in all CF patients. We are grateful to the CF Foundation for expanding its support for our CF clinical program, including our Phase 2b clinical development program in which the event rate of pulmonary exacerbations will be the primary efficacy endpoint,” commented Yuval Cohen, Ph.D., CEO of Corbus.
Lenabasum is a unique investigational drug specifically designed to trigger the resolution of inflammation without immunosuppression. In March 2017, data from an 85-subject double-blind, randomized, placebo-controlled Phase 2 study showed lenabasum treatment was associated with a decreased proportion of CF subjects with pulmonary exacerbations, longer time to first pulmonary exacerbation during the trial, and reduced inflammatory cells and mediators in sputum. The Company’s prior Phase 2 study was supported by the CF Foundation through a $5 million Development Award.
“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 2 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,” added James Chmiel, M.D., M.P.H., co-principal investigator of the Phase 2b study and specialist in pediatric pulmonary diseases in the Division of Pediatric Pulmonology, Allergy, Immunology and Sleep Medicine and Associate Director of the LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies & Children’s Hospital.
As previously announced, the Company’s Phase 2b multicenter, double-blinded, randomized, placebo-controlled study will enroll approximately 415 subjects with CF who are at least 12 years of age and at increased risk for pulmonary exacerbations. Secondary efficacy outcomes include other measures of pulmonary exacerbations, change in Cystic Fibrosis Questionnaire-Revised Respiratory domain score and change in forced expiratory volume in 1 second (FEV1), % predicted. The study will be conducted in approximately 100 sites across North America, Europe, Israel and Australia. Subjects will be centrally randomized to one of three cohorts to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day for 28 weeks, with 4 weeks follow-up off active treatment. This Phase 2b CF study was designed with input from the Therapeutic Development Network of the Cystic Fibrosis Foundation and the European Cystic Fibrosis Society Clinical Trials Network. Patient dosing of this Phase 2b study is expected to commence this quarter and the Company expects to compete the study by the end of 2019.
Lenabasum was granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA in 2015 and Orphan Drug Status from the European Medicines Agency (EMA) in 2016.
Conference Call and Webcast Information
As previously announced, Corbus management will host a conference call for investors, analysts and other interested parties today at 10:30 a.m. EST to discuss the Company’s upcoming Phase 2b study evaluating lenabasum for the treatment of CF.