Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) reported that its drug, Lenabasum did not meet its primary efficacy endpoint of reducing the rate of PEx. Lenabasum is a novel, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and resolves inflammation and limits fibrosis in animal and human models of disease. CB2 is preferentially expressed on activated immune cells and on fibroblasts, muscle cells, and endothelial cells.
“While I am disappointed that the study did not achieve its primary endpoint, I am encouraged by findings of potential reduction in exacerbation rates in subjects with similar lung function and treatment with CFTR-modulators,” said James Chmiel, M.D., MPH, Principal Investigator of CF-002. “I look forward to further analyses of the data, because they may confirm the initial clinical rationale to continue development of lenabasum for treatment of pulmonary exacerbations in people with CF. This was the first interventional study in CF to select for patients who have high rates of pulmonary exacerbations and one of the largest CF studies to date. The negative impact of recurrent pulmonary exacerbations on the health and quality of life of people with CF cannot be overstated, nor can the need to find non-immunosuppressive treatments to control the lung inflammation that causes these events.”
The company announced the presentation of the preliminary data from its 28-week Phase 2b study of lenabasum in patients with cystic fibrosis (CF) at the North American Cystic Fibrosis Conference (NACFC) held online, Oct 7-23, 2020. The data are being presented in poster number 817 titled: “CB2 Agonist, Lenabasum, for the Treatment of Pulmonary Exacerbations in Cystic Fibrosis.” These data can be found at the following link: NACFC Poster #817
CF-002 was a multinational Phase 2b study evaluating the efficacy and safety of lenabasum in CF. This was a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day for 28 weeks, with 4 weeks safety follow-up off active treatment. The primary efficacy endpoint was the event rate of new PEx per subject per 28 weeks, when the primary definition of new PEx was physician diagnosis of PEx, prescription of new antibiotics for that PEx starting more than 28 days after completion of the last antibiotic course for any previous PEx, with 4 out of 12 Fuch’s criteria present in the subject. The Phase 2b CF study was funded in part by a Therapeutic Development Award for up to $25 Million from the Cystic Fibrosis Foundation.
A few weeks ago, Corbus said it would reallocate resources towards its lenabasum clinical development program in dermatomyositis and systemic lupus erythematosus and its pipeline of other novel ECS-targeting drug candidates. The pipeline includes cannabinoid receptor type 1 (CB1) inverse agonists, follow-on cannabinoid receptor type 2 (CB2) agonists, as well as other programs with their own unique mechanism of action in the ECS field. The Company is allocating resources and implementing cost reductions designed with the objective of extending its cash runway to mid-2022. Corbus recorded cash and cash equivalents of approximately $83 million at September 30, 2020.