BBI-3000 is a highly selective, potentially safer and potent RXR retinoid currently under development for retinoid responsive skin conditions. While we believe there are several skin indications where a novel RXR retinoid agonist could be developed, we are currently focusing our development of BBI-3000 as a potential oral treatment for subjects with cutaneous t-cell lymphoma (CTCL), and are targeting the submission of an investigational new drug (IND) application in 2018, followed by a proof-of-concept study.

Retinoids are derivatives of vitamin A that play a pivotal role in a diverse group of biologic processes including, but not limited to, cellular proliferation, differentiation, apoptosis, and development. The biological activity of the retinoid depends in part on the binding availability to RAR and RXR receptors. There are several topical retinoids currently on the market that primarily bind to RARs and have shown efficacy in the treatment of several skin conditions, including acne and psoriasis (e.g., tazarotene, adapalene and tretinoin). Additionally, bexarotene, an RXR retinoid, is commercially available as a treatment option for subjects with CTCL, however, a common adverse reaction with its use is hyperlipidemia, resulting in abnormally elevated levels of lipids in the blood.

BBI-3000 is currently being tested by the National Cancer Institute (NCI) in Phase 1 clinical studies as a chronic, orally administered chemoprevention of breast cancer. The product has been well tolerated in the NCI investigations conducted to date, providing a potential indication of the overall favorable systemic safety profile of BBI-3000.