BBI-2000, a first-in-class, novel anti-inflammatory small peptide, is currently in the pre-clinical stage of development (IND-enabling studies complete) with clinical trials planned to commence during the first half of 2017.
The development of this novel therapeutic approach was triggered by the discovery that a naturally occurring redox-regulating protein that scavenges reactive oxygen species also exhibits an inhibitory effect over Langerhans' cell (LC) migration. Extensive research was conducted to identify a smaller sequence of the parent molecule that retained the anti-inflammatory activity and was suitable for topical administration, particularly relevant to skin conditions involving Langerhans' cells mobilization in their physiopathology (e.g. contact and atopic dermatitis).
The ability to inhibit LC mobilization in a hyperreactive skin setting, such as the one observed in contact dermatitis, would be expected to limit the inflammatory response that follows skin injury in this disease. Although contact dermatitis is a complex condition and to date, there is no product that has that same mechanistic approach as that of BBI-2000, considering the pathophysiology of this disease it is expected that a mechanism that limits the hyperreactivity to external triggers would have beneficial effect.
Additionally, Brickell has conducted pre-clinical pharmacology studies where BBI-2000 has consistently demonstrated a substantial anti-inflammatory effect in multiple contact hypersensitivity animal studies, along with the evidence of inhibition of LC migration in repeated pharmacology investigations.
Considering the nature of BBI-2000, as a small peptide whose sequence is part of a naturally occurring protein and its predicted metabolism via peptidase degradation into naturally occurring amino acids, BBI-2000 has the possibility to be a safe and effective preventive and treatment alternative for subjects with contact dermatitis, suitable for chronic use.