GlaxoSmithKline and Scynexis have announced an exclusive agreement to commercialize and further develop Brexafemme (ibrexafungerp tablets), a treatment for vulvovaginal candidiasis (VVC), commonly known as a vaginal yeast infection, and for the reduction in incidence of recurrent VVC (RVVC).
As part of the agreement, GSK will gain exclusive rights to commercialize Brexafemme globally, with the exception of the US, where Scynexis will retain commercialization rights. GSK will also hold the option to continue developing ibrexafungerp, which is currently in Phase III clinical trials for the potential treatment of invasive candidiasis.
GSK will provide Scynexis with an upfront payment of $90m (€83m), and a potential $503m in additional payments based on certain milestones, including regulatory approvals and sales targets.
Scynexis will retain its right to develop all other assets derived from enfumafungin, and GSK will have the right of first negotiation to these potential compounds.
According to the companies, VVC affects up to 75% of women at least once in their lifetime, with 40-45% having two or more episodes. They added that Brexafemme also has a distinct mode of action compared to other antifungals, as it actively kills the fungus, as opposed to inhibiting growth.
Further than this, the companies outlined that rates of resistance to other antifungals are also rising, and therefore the development of first-in-class therapy could provide an important new oral therapy.
Luke Miels, CCO of 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.”
GSK has increased its focus in recent years into the antibiotic space, particularly in areas where antimicrobial resistance is a developing issue, as Miels stated.
Last year, the company announced that it had stopped Phase III trials into an antibiotic treatment for urinary tract infection, as the efficacy of the treatment was recognized. As a result, the treatment is being put forward to regulators for approval and could become the first new oral antibiotic treatment for the condition in 20 years.
A few months prior to this news, GSK made the decision to purchase the licensing rights to Spero’s late-stage antibiotic also against urinary tract infections.