Hyloris and Purna Female Healthcare announce a partnership to develop the new women’s health product Novel, dual mode-of-action combination product for the treatment of severe and recurrent vulvovaginal candidiasis (rVVC). Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), an innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals, and Purna Female Healthcare (“PFH”), a spin-off founded by Purna Pharmaceuticals NV and Creafund NV, today announce that they have entered into a partnership to develop and commercialise an innovative 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 well-known antifungal Miconazole with Domiphen Bromide (MCZ-DB). Under the terms of the agreement, Hyloris has committed to milestone related investments of up to EUR 4.3m in PFH (of which EUR 1.27m 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, resulting in 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, with an estimated economic burden from lost productivity of up to $14.39 billion annually by 2030. There is a high unmet need for novel treatment options in severe and rVVC as current standard of care treatments have significant drawbacks, including lack of efficacy, the development of drug resistance due to continued use and liver toxicity. 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, possibly addressing the high unmet needs in complicated and recurrent VVC.