Transforming treatment globally for intimate infections and STIs
Lund-based Pharmiva, founded in 2015, is based around delivery technology developed at the topical CRO Zelmic. The company has a joint focus: improving women's health by transforming the treatment of intimate and sexually transmitted infections, whilst tackling the challenge of antimicrobial resistance.
Antimicrobial resistance is a growing challenge around the world. This is a particular concern for sexually transmitted and intimate infections, where there are emerging cases of infections resistant to frontline antibiotics.
"Pharmiva's vision is to transform treatment and relieve problems related with STIs and intimate infections," said Anna Holmberg, managing director.
Pharmiva's management team has over 40 years' experience in developing medical products, and brings specialist skills in dermatology and drug delivery. The company closed new financing in June, raising SEK14 million, and plans an initial public offering in one or two years' time.
Bringing antibiotic-free treatment to women's health
Pharmiva's technology platform is based around a combination of naturally-occurring compounds known as HPLA, which have potential for non-antibiotic treatment of intimate infections, STIs, as well as relieving symptoms and reinforcing the body’s natural defences.
The company's lead product is an over-the-counter antibiotic-free vaginal mousse developed to treat and prevent bacterial vaginosis. The infection affects 300 million women worldwide. It is mainly treated with antibiotics, and the recurrence rate is between 30% and 50%.
The mousse contains lactic acids, hydrogen peroxide, lipid crystals and oxygen. The lipid crystals prevent autooxidation of hydrogen peroxide and increases efficacy and duration of the antimicrobial effect. It is delivered in a single-use canister and applicator created by Swedish company Zelmic that is designed to deliver a foam that expands and fills the vaginal cavity, covering the whole vaginal surface. The product is a medical device
Pharmiva's mousse does not trigger antimicrobial resistance, and also has potential in the treatment and prevention of vaginal fungal infections. It also restores vaginal pH, reinforces natural defences, reduces pathogens, and increases lactobacilli, restoring the vaginal microbiota.
In a phase I/II clinical study in 30 women with severe bacterial vaginosis, the product provided an immediate clearance of bacterial vaginosis and a long-lasting effect on malodour and vaginal discharge. The effect was clinically proven with a 100% improvement of malodour within one week and a 50% improvement about one month after applying the product once.
"We are targeting women who want to be antibiotic-free," said Holmberg. "Manufacturing is already set up, and we expect to launch in early 2019 in Europe, and then expand to Asia and the US. We will seek distributors and sales partners in some regions. We estimate the global market for our lead bacterial vaginosis product to be well in excess of $1 billion"
Moving into prescription medications
The next step for Pharmiva is to develop a prescription-only product for the treatment of gonorrhoea. This STI affects around 100 million people worldwide, and rates are increasing by around 10% each year. Gonorrhoea levels reached a record high in the US in 2017, and antibiotic-resistant strains are emerging.
"We are planning a clinical program for our gonorrhoea therapeutic, which is based on the same technology as the mousse for bacterial vaginosis. We already have safety data and hope to move directly into a phase II/III trial. We predict that we could submit this for approval around 2022," said Holmberg.