Corbus’ anabasum meets safety and tolerability goals in cystic fibrosis study

A phase 2 trial evaluating Corbus Pharmaceuticals’ multiple doses of anabasum (Resunab) has met its primary objective in patients with cystic fibrosis, demonstrating an acceptable safety and tolerability profile with no severe adverse events.

The study’s primary objective was to test safety and tolerability of anabasum in adults with CF who had FEV1 ≥ 40% predicted and remained on background CF medications, including prophylactic antibiotics.

Corbus had recruited 85 adult CF patients with baseline forced expiratory volume in 1 second (FEV1) percent predicted ≥ 40% in 16-week study to assess the anabasum.

Anabasum cohorts demonstrated a dose-dependent reduction in multiple acute pulmonary exacerbations. In this type of cohorts, intravenous (IV) antibiotics will be compared against placebo.

In addition, anabasum showed a uniform reduction in a number of inflammatory cell types in sputum, including total leukocytes, neutrophils, eosinophils, and macrophages.

Inflammatory mediators such as interleukin-8, neutrophil elastase, and immunoglobulin G have been reduced in sputum by anabasum in a dose-dependent manner.

The trial is an international, multi-center, double-blinded, randomized and placebo-controlled phase 2 study, which was supported by $5m development grant from Cystic Fibrosis Foundation Therapeutics (CFFT).

Corbus Pharmaceuticals CEO Yuval Cohen said: "These positive results coincide with our third anniversary as a company and come on the heels of positive data from our Phase 2 study in systemic sclerosis.

“We are very grateful to all the patients, investigators and clinical staff who participated in this study and to Cystic Fibrosis Foundation Therapeutics for their support."