Corbus Eyes Restructuring Process as Lenabasum Continues to Fall Short

Corbus Pharmaceuticals announced today that it intends to restructure its workforce and reallocate capital toward specific clinical and preclinical programs. Specifically, resources will be put toward its lenabasum clinical development program in dermatomyositis (DM) and systemic lupus erythematosus (SLE). Funds will also be utilized to enhance Corbus’ pipeline of novel endocannabinoid system-targeting drug candidates, and the company’s workforce will be reduced by up to 54%.

Lenabasum, the novel, oral, small molecule that selectively binds as an agonist to cannabinoid receptor type 2 (CB2), has demonstrated acceptable safety and tolerability profiles in clinical studies to date.

“I want to thank our employees for their invaluable contributions to Corbus and the commitment they have shown to improving lives of people with rare inflammatory diseases,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “We believe that reorganizing the business is critical to our success. We will continue to focus our strategy on the potential for lenabasum in serious autoimmune diseases, including through the completion of our Phase III clinical trial in DM with an expected data readout in Q4 of next year, and leveraging our preclinical pipeline.”

Corbus recently released topline results from a 28-week Phase IIb trial looking into lenabasum for the treatment of cystic fibrosis (CF). The data showed that the product did not reduce the rate of new pulmonary exacerbations compared with placebo.

Researchers initially thought that lenabasum could potentially reduce CF-related pulmonary exacerbations, a common symptom in patients.

“We are very disappointed that the study did not meet the primary endpoint. We look forward to providing more details of study results starting tomorrow at NACFC,” said Barbara White, M.D., Chief Medical Officer and Head of Research of Corbus. “We thank the participants, the staff at study sites, the Cystic Fibrosis Foundation and the European Cystic Fibrosis Society Clinical Trials for their support and partnership throughout this study.”

In September, lenabasum also did not perform well in Corbus’ Phase III RESOLVE-1 trial looking into the potential treatment of diffuse cutaneous systemic sclerosis (SSc). According to data from the study, there were no significant differences in primary and secondary endpoints compared to a placebo. At the time, the company stated that it would continue to analyze its data.

“We are surprised and deeply disappointed that the RESOLVE-1 trial did not meet its primary endpoint,” Cohen said at the time of the announcement. “I would like to extend my gratitude to the participants in the study and the clinical staff at the study studies, as well as to the Corbus employees, for their hard work and dedication. We now look forward to upcoming topline results from our study of lenabasum in patients with cystic fibrosis.”

Previously, lenabasum had shown promise in Phase II studies looking into the treatment of diffuse cutaneous SSc.  

“Whilst the immediate study results are disappointing, RESOLVE-1 provides a rich dataset to understand for the first time how to better target treatments for SSc based upon clinical parameters and concomitant treatment,” said Christopher Denton, co-principal investigator of RESOLVE-1 and professor of Experimental Rheumatology at UCL Medical School and consultant rheumatologist and joint director of the Centre for Rheumatology, Royal Free Hospital, London. “We are already querying the data to understand the natural history of early diffuse cutaneous SSc and the potential benefits of lenabasum in these subjects.”