GSK plc and SCYNEXIS, Inc. announced they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.
Infectious diseases and HIV represent around two-thirds of GSK’s pipeline. Brexafemme complements GSK’s first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI).
Luke Miels, Chief Commercial Officer, GSK said: “The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics.”
VVC affects up to 75% of women at least once, with 40-45% having two or more episodes1. Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals which inhibit fungal growth. It is the only oral antifungal US FDA-approved treatment for VVC and reduction of RVVC. With rates of resistance to other antifungal treatments rising,Brexafemme addresses a clear unmet need for new oral treatments.
David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS said: “This agreement represents a major milestone for SCYNEXIS, maximising Brexafemme’s commercial potential in VVC and further validating our vision of the critical role for this first-in-class antifungal in invasive infections. We are thrilled to partner with GSK on this high-potential asset and will continue progressing ibrexafungerp’s phase III programme in invasive candidiasis (IC).”
IC is a life-threatening infection that affects the blood or internal organs. There are around 750,000 cases of IC every year worldwide.2 In the US, it is one of the most common causes of bloodstream infections in hospitalised patients and can lead to more extended hospital stays and higher associated costs.