Hyloris Pharmaceuticals and Purna Female Healthcare have entered into a partnership to develop and commercialise a combination therapy for the treatment of severe and recurrent vulvovaginal candidiasis (rVVC).
PFH is a special purpose vehicle founded to exclusively develop a local topical combination formulation of the antifungal Miconazole with Domiphen Bromide (MCZ-DB). Under the terms of the agreement, Hyloris has committed to milestone related investments of up to $5.15 m in PFH (of which $1.52 m at signing) and will lead the commercialisation and out-licensing activities. Hyloris owns 20% of PFH and is eligible to receive up to a maximum of 45% of the net profits generated by PFH.
VVC is a vaginal fungal infection commonly caused by the yeast Candida albicans, affecting as many as one in every two women during their life, with about 175 million units sold per year globally. Up to 20% of VVC patients develop severe to recurrent VVC where reinfection occurs more than four times per year. These are long-term conditions that cause significant pain and distress.
Recent preclinical studies have demonstrated that the activity of Miconazole (MCZ), the current topical standard of care, when combined with the Miconazole potentiator Domiphen Bromide, can combat the occurrence and recurrence of mucosal biofilm-related vaginal Candida infections. MCZ and DB work synergistically where DB increases the permeability of the plasma membrane and the vacuolar membrane of Candida spp., and MCZ acting fungicidal, thereby effectively destroying fungal activity and preventing further fungal growth. The synergistic mode-of-action of topical MCZ-DB has the potential to be effective against azole-resistant infections, potentially addressing the high unmet needs in complicated and recurrent VVC.
Purna Female Healthcare has exclusively in-licensed MCZ-DB and associated IP owned by KU Leuven and the University of Antwerp (Belgium).
Stijn Van Rompay, CEO of Hyloris, commented: “Patients with severe and rVVC have limited effective treatment options and we believe that the novel MCZ-DB combination therapy has significant potential to help women manage this underserved condition. The strong scientific rationale and proven efficacy and safety profile of MCZ provide further upside and dramatically reduce potential development risk, time, and cost. We are very pleased to have entered into this agreement with Purna Female Healthcare to deliver a much-needed innovation in women’s health, demonstrating our ability to identify and reformulate known products to enhance current treatment practices.