Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) has completed patient enrolment paving the way for commencement of Phase 2 study of its candidate drug, Resunab. The clinical stage drug under development targets rare chronic, serious inflammatory and fibrotic diseases. The primary goal of the study is to evaluate the drug’s safety tolerability and efficacy in adults with Cystic fibrosis.
Resunab Phase 2 Study
Enrolled patients will be treated with Resunab for a period of 84 days followed by a follow-up period of 28 days. The study will analyze lung function as measured by forced expiratory volume in one second as well as Resunab’s impact on sputum microbiota and biomarkers of inflammation in sputum.
Corbus Pharmaceutical expects top-line results from the study as early as the first quarter of 2017. The Cystic Fibrosis Foundation has donated $5 million to the company for the phase 2 study. During the second quarter, the company completed a $15 million direct offering, which provides it additional financial power to support such trials.
“Moving forward, we remain committed to building on the solid foundation we have created for Corbus and advance Resunab as an important potential therapy for individuals with serious inflammatory and fibrotic diseases,” said CEO Yuval Cohen.
Resunab has already received Orphan Drug and Fast Track status from the FDA. Positive results from the phase 2 study should set it on the path to regulatory approval both in the US and abroad.
Emerging Risks
The clinical stage pharmaceutical company is fresh from posting a second net loss of $4.189 million and in dire need of positive news from clinical trials to provide support to the stock. Net loss for the first six months of the year soared to highs of $7.1 million from $4.1 million as of last year same period. Corbus Pharmaceutical attributes the increased net loss to increased spending on clinical studies for cystic fibrosis and systemic sclerosis as well as increased staffing costs.
Getting it right on clinical trials is thus essential for Corbus Pharmaceuticals Holdings Inc(NASDAQ:CRBP) if it is to avoid backlash from the street given its declining cash balance and soaring net loss.
