Samcyprone™ is a proprietary topical formulation of diphenylcyclopropenone (DPCP), a small molecule that has been used since the late 1970’s to stimulate regrowth of hair in patients with alopecia areata. Recent publications have supported its use as an immunomodulator for the treatment of alopecia areata, warts and cutaneous metastases of malignant melanoma. Although it has been used by physicians for several decades, it has never been reviewed or approved by a regulatory authority as a drug. DPCP is a new chemical entity under a U.S. IND. Samcyprone™ is expected to achieve market exclusivity post approval. Efficacy with DPCP has been reported in peer-reviewed journals for the three target indications: warts, alopecia areata and cutaneous metastasis of melanoma. The combined market potential for a treatment for these diseases is estimated >$1B.
Licensed by RXi in 2014, Samcyprone™ is an immunomodulator that works by initiating a T-cell response. T-cells or T lymphocytes are a type of white blood cell that play a key role in cell-mediated immunity.3 The use of Samcyprone™ allows sensitization using much lower concentrations of DPCP than possible with existing DPCP solutions, avoiding hyper-sensitization to subsequent challenge doses. A Phase 2a clinical trial for the treatment of cutaneous warts with Samcyprone™ is underway. In March 2015, the Company was granted Orphan Drug Designation for Samcyprone™ by the U.S. Food and Drug Administration for the treatment of malignant melanoma stage IIb to IV.
The acquisition of this second Phase 2 development program increases the value proposition of the Company by expanding its clinical pipeline and positioning RXi strongly as a clinical development stage company. It is noteworthy that the mechanism of action of Samcyprone™ is linked to DPCP’s ability to alter the expression of multiple genes and miRNAs involved in the immune response. Our work with Samcyprone™ should allow us to discover specific targets for the potential treatment of immunological disorders that are relevant to the skin as well as various systemic diseases. This approach may result in the development of sd-rxRNA or other drugs that are more potent and selective for various indications, including the treatment of alopecia areata, warts or cutaneous metastases of malignant melanoma.