– Company continues to make consistent progress in the clinical development programs of lenabasum, in rare, chronic and serious inflammatory and fibrotic diseases –
Corbus Pharmaceuticals Holdings, Inc. (CRBP) (“Corbus” or the “Company”), a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases, announced today its financial results for the first quarter ended March 31, 2018.
The Company also provided an update on its corporate progress, clinical status and anticipated milestones for lenabasum, its novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and halt fibrosis in rare autoimmune and inflammatory diseases.
Recent Clinical and Corporate Highlights
- Commenced patient dosing in Phase 3 study in systemic sclerosis;
- Received a Development Award for up to $25 million from the Cystic Fibrosis Foundation to support the Phase 2b study in cystic fibrosis;
- Commenced patient dosing following agreement with FDA on a Phase 2b cystic fibrosis study design with pulmonary exacerbations as sole primary endpoint;
- Commenced patient dosing in 100-patient Phase 2 clinical study in systemic lupus erythematosus, which is being conducted and funded by the NIH;
- Publication of clinical data demonstrating mechanism of action of lenabasum in human blister model; and
- Ended the first quarter of 2018 with approximately $71 million in cash and cash equivalents, an increase of $8.4 million from the start of the year.
“We continued to make progress in the first quarter of 2018 in all four of our clinical programs: systemic sclerosis, cystic fibrosis, dermatomyositis and lupus. We look forward to achieving a number of additional important milestones this year,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.
Systemic Sclerosis Clinical Program Update
Systemic sclerosis is a serious autoimmune disease affecting approximately 90,000 people in the US and Europe and is associated with significant morbidity and up to 60% 10-year mortality. There are currently no drugs specifically approved by the FDA for treatment of systemic sclerosis.
Patient dosing is ongoing in the Phase 3 (“RESOLVE-1”) study of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (“systemic sclerosis”). The international, multicenter Phase 3 RESOLVE-1 study is a double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of systemic sclerosis. The study will enroll approximately 354 subjects at 70 sites in North America, Europe, Israel, Japan, South Korea and Australia. The planned duration of treatment with study drug is 52 weeks. Subjects are randomized 1:1:1 to receive lenabasum 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day.
The primary efficacy outcome of the RESOLVE-1 study will be change from baseline in modified Rodnan Skin Score (“mRSS”), a measure of skin fibrosis and a standard clinical trial outcome in systemic sclerosis. Secondary outcomes of the RESOLVE-1 study include patient- and physician-reported outcomes, forced vital capacity, the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (“ACR CRISS”) score, a novel composite measure of clinical improvement from baseline that incorporates change from baseline in mRSS, and lung function. These same outcomes were measured in the Phase 2 study as well as the follow-on open-label extension study for which the 28-week results in all of these efficacy measures were presented in November 2017 at the American College of Rheumatology conference. For more information on the Phase 3 study, please visit ClinicalTrials.gov and reference Identifier NCT03398837.
Corbus expects to report topline results from the Phase 3 RESOLVE-1 study in the first half of 2020 and will provide regular updates from the ongoing open-label extension study.
Lenabasum has been granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the FDA and Orphan Designation from the European Medicines Agency (“EMA”).
Cystic Fibrosis (“CF”) Clinical Program Update
Cystic fibrosis is a chronic, life-threatening, genetic rare disease, characterized by chronic lung inflammation that leads to lung damage and fibrosis that affects approximately 30,000 patients in the U.S and 75,000 patients worldwide. The current average life expectancy for CF patients is 40 years. The harmful inflammation and accompanying fibrosis in CF damages multiple organs, impairs organ function, reduces health-related quality of life, and is the most common cause of mortality. There remains a recognized unmet need for safe and effective drugs that target chronic inflammation and fibrosis for the treatment of CF on top of standard of care but without the risk of immunosuppression currently associated with existing anti-inflammatory drugs.