Vulvovaginal candidiasis affects around three in four women at least once during their lifetime, while an estimated 140 million women worldwide experience recurrent infections. Although existing antifungal therapies can treat an acute episode, they do not always provide lasting protection against recurrence. Increasing antifungal resistance further highlights the need for new, complementary approaches.

Fempharma’s development pipeline includes a zinc-enabled vaginal gel designed to address recurrent vulvovaginal candidiasis from a different perspective. The project is investigating whether controlled local zinc delivery can complement standard antifungal treatment by modulating the interaction between Candida albicans, the vaginal mucosa and the body’s inflammatory response.

The scientific rationale

Research led by the University of Exeter’s MRC Centre for Medical Mycology identified the fungal zinc-binding protein Pra1 as a potential driver of inflammation in vaginal candidiasis. Preclinical research suggests that carefully controlled zinc availability may suppress Pra1 production and reduce the inflammatory response associated with symptoms such as itching and burning. The findings were published in Science Translational Medicine.

These findings provide a promising scientific basis for the development of locally delivered zinc formulations. However, translating this mechanism into a clinically validated treatment requires further formulation development, mechanistic research and controlled clinical evaluation.

From early clinical evidence to a new product candidate

Fempharma has completed an initial randomized clinical study evaluating a zinc-containing vaginal gel used after standard oral fluconazole treatment. The study generated important preliminary clinical and biological data and helped establish the feasibility of this therapeutic concept.

Building on these findings, Fempharma is developing a next-generation product candidate specifically intended for recurrent vulvovaginal candidiasis. The ongoing project focuses on:

• optimizing the formulation and zinc-delivery profile;
• confirming the proposed mechanism of action;
• identifying the most appropriate treatment regimen;
• developing a scalable and reproducible manufacturing process;
• generating robust clinical evidence on recurrence, durability and safety; and
• establishing the appropriate regulatory pathway.

The objective is to progress from an encouraging early clinical signal to a fully characterized and clinically validated therapeutic solution capable of addressing the underlying drivers of recurrence.

“Our ambition is to move beyond repeatedly treating individual infections. We are developing a scientifically grounded approach that could help prevent recurrence while supporting recovery of the vaginal environment.”
— Peter Takacs, PhD, CSO of Fempharma

The product candidate described above remains under development and has not yet been approved for the prevention or treatment of recurrent vulvovaginal candidiasis.