- Positive data from three consecutive Phase 2 studies in rare and serious chronic inflammatory and fibrotic diseases provides validation of anabasum’s unique activity of resolving inflammation and halting fibrosis without immunosuppression
- Company on track to commence Phase 3 study in systemic sclerosis, Phase 2b study in cystic fibrosis and Phase 2 study in systemic lupus erythematosus before year end
- Recent public offering completed raising approximately $32.5 million in gross proceeds extends expected cash runway into Q4 2019
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 its financial results for the third quarter ended September 30, 2017.
The Company also provided an update on its corporate progress, clinical status and anticipated milestones for anabasum, its novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis in rare autoimmune inflammatory diseases.
Recent Clinical and Corporate Achievements
- Reported positive, statistically significant 6-month clinical data from the ongoing open-label extension (“OLE”) study in systemic sclerosis (“SSc”) which is a continuation of the positive double-blind placebo-controlled Phase 2 study reported in November 2016;
- Reported positive, statistically significant Phase 2 results from the double-blind, randomized, placebo-controlled trial in dermatomyositis (“DM”), a rare autoimmune disease;
- Raised $32.5 million in gross proceeds from a secondary public offering;
- Appointed Mr. Paris Panayiotopoulos to Board of Directors; and
- Awarded U.S. Patent covering the use of pharmaceutical compositions comprising anabasum for treatment of rare autoimmune, inflammatory diseases through 2034.
“We are very proud that in less than four years we have successfully executed our clinical development and corporate strategy enabling us to be in position to launch our first Phase 3 late-stage study. Over the past 12 months, we have reported positive Phase 2 clinical data in succession in three distinct rare diseases with significant morbidity and mortality and that, combined, affect over 200,000 individuals in the US and EU,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “This important progress has positioned us for the solid implementation and execution of our four clinical studies in systemic sclerosis, cystic fibrosis, dermatomyositis and lupus. We are looking ahead to an exciting 2018.”
Systemic Sclerosis Clinical Program Update
On November 5, 2017 at the American College of Rheumatology (“ACR”) Annual Meeting, Corbus presented 6-month data from the on-going OLE study in systemic sclerosis. Thirty-six subjects are participating in the ongoing OLE which followed the conclusion of the 16-week double blind placebo controlled study. Subjects continued to improve in multiple clinical endpoints including a mean improvement in the modified Rodnan Skin Score (mRSS) of -8.4 points (p < 0.0001) from baseline at the start of the Phase 2 double blind placebo controlled portion of the study. 75% of subjects achieved a degree of improvement in mRSS (reduction ≥ 5 points and > 25% baseline) that has been associated with improved survival and exceeds that previously reported in other clinical trials or registries in systemic sclerosis. A third of the subjects reached a low mRSS ≤ 10 points. The ACR Composite Response Index in diffuse cutaneous systemic sclerosis score (ACR CRISS) continued to increase steadily with anabasum treatment and reached 71% (median) from study start. The speed and degree of improvement in multiple efficacy outcomes exceeds that previously reported in other clinical studies or registries in systemic sclerosis. To access the open label data and other five posters presented at ACR please click here.
Corbus is on track to commence a Phase 3 study of anabasum for the treatment of systemic sclerosis with the mRSS as the primary endpoint before year end and expects to report topline results before the end of 2019.
Systemic sclerosis is a chronic, systemic autoimmune rheumatic rare disease with an unclear etiology that affects approximately 90,000 people in the United States and Europe, with disease onset typically in mid-life and lung fibrosis resulting in a 10-year mortality rate of 40-60%. Currently, there are no FDA-approved treatments specifically indicated for the treatment of SSc, other than pulmonary artery hypertension secondary to connective tissue diseases such as SSc.
Anabasum has been granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the FDA and Orphan Designation from the EMA.
Expected Near-Term Milestones:
- Commence Phase 3 systemic sclerosis study by end of 2017; and
- Report 12-month data from the on-going OLE study in mid-2018.
Cystic Fibrosis (“CF”) Clinical Program Update
In March 2017, Corbus reported positive topline data from the double-blind, randomized, placebo-controlled Phase 2 study of anabasum for the treatment of CF showing that anabasum, compared to placebo, reduced the rate of pulmonary exacerbations, reduced multiple inflammatory biomarkers and had an acceptable safety and tolerability profile. The 16-week study was an international, multi-center study supported by a $5 million Development Award from Cystic Fibrosis Foundation Therapeutics, Inc. Data from this study was presented at the European Cystic Fibrosis Society (“ECFS”) conference in June 2017 and was also recently presented at the North American Cystic Fibrosis Conference (“NACFC”). To access the posters presented at NACFC, please click here.