BBI-2000 is a first-in-class, novel, anti-inflammatory small peptide, that recently completed testing in a proof-of-concept (POC) clinical study for the prevention and treatment of allergic contact dermatitis. The POC study examined the safety and efficacy of a topical formulation of BBI-2000 in preventing a primary hypersensitivity reaction (“PHR”) and in treating the inflammation associated with a secondary hypersensitivity reaction (“SHR”) due to a known sensitizer. BBI-2000 was found to be safe and well tolerated, and positive data was observed indicating its potential efficacy in dampening both PHR and SHR reactions. In order to more fully elucidate BBI-2000’s potential efficacy, we intend to conduct a second POC study in late 2018 to investigate the influence of dose and duration of therapy in preventing the occurrence and recurrence of contact hypersensitivity dermatitis.

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, it is expected that a mechanism that limits the hyperreactivity to external triggers would have a beneficial effect in both preventing and treating contact dermatitis. Based on this, we believe BBI-2000 has the possibility to be a safe and effective preventive and treatment alternative for subjects with contact dermatitis, suitable for chronic use.