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Surprise discovery leads to treatment for common infection

Image: Istock
Image: Istock

Each year, one in four women suffers from bacterial vaginosis, something that is currently treated with antibiotics. However, recently a gentler, antibiotic-free alternative has been authorised for sale in the EU. The chance discovery behind the innovation was made by a group of researchers from Lund University in Sweden.

Stinging, itching and odorous vaginal discharge is a common and a stigmatised condition that may be due to an imbalance in the vaginal bacterial flora, a yeast infection or both. Bacterial vaginosis is currently treated with antibiotics or antiseptic medicines. They kill all bacteria in the genital area effectively but mercilessly. 

An antibiotic-free alternative will soon be available in pharmacies. It is a vaginal suppository, the active ingredient of which lowers pH and promotes natural lactobacilli – beneficial for women affected by bacterial vaginosis, and often yeast infections, since they can occur simultaneously. 

Clinical trials show that half of the patients experience symptom relief after just 24 hours and 70 per cent are completely symptom-free after six days. The risk of relapse is also low compared to antibiotics.

It was ten years ago that you discovered, by chance, that you were on to something. Tell us, how did it happen?

Ulf Ellervik, Professor of Chemistry: “We were working on producing a product containing lactic acid, which is naturally present in the vagina and keeps the environment acidic and pathogen-free. However, making medicines from lactic acid is not easy. We therefore looked at ways of binding it to other molecules, including an oxidised form of glucose, gluconodelta-lactone (GDL), which is also used in food. 

When we did more thorough tests, we realised that we didn't actually need the lactic acid. The results were actually better with pure GDL, which was unexpected. Because GDL, unlike lactic acid, is a solid, it is also easy to press into suppositories.”

What did this mean to you? 

“Coming up with a chemical idea that can then be used by patients is incredibly pleasing, it's a fantastic boost. Added to that is the fact that we have managed to navigate the tricky journey from patents, through clinical trials and now to CE marking. This project has been a happy marriage between chemistry and medicine, where we stumbled over surprising and useful discoveries along the way.”

How do women know whether they have a yeast or bacterial infection in the genital area?

Consultant Obstetrician and Gynaecologist Helena Strevens: “That can actually be quite difficult for an individual patient to determine. The conditions have similar symptoms. Bacterial vaginosis causes odorous discharge, while yeast infections often cause intense itching. Mixed infections are common.”

Is it possible to avoid the problem?

“We don't really know why some people are affected and others are not. Hereditary factors and different types of bacterial flora may play a role. Prolonged bleeding reduces the acidity of the genital tract and negatively affects the bacterial flora. But it is not due to poor hygiene, as many believe – a misconception that contributes to the stigmatisation of the condition. Indeed, washing the mucous membranes of the genital area with soap or showering the vagina internally is certainly not recommended. Soap should only be used on the skin.”

Today, bacterial vaginosis is mainly treated with antibiotics. What is different about your product?

“Antibiotics are a very effective treatment, precisely because they kill all bacteria. However, because they also kill good bacteria, antibiotics can cause side effects in the form of secondary yeast infections and fairly rapid recurrence of symptoms, as well as stomach problems if taken orally. Our product lowers the pH and encourages the growth of favourable bacteria, which keeps the unfavourable bacteria and fungi at bay, even in the long term. 

And, since it will be available without a prescription, there will be no need to see a gynaecologist before starting treatment. And, last but not least, this product does not lead to antibiotic resistance amongst the bacteria in question or in general.”

Background:

Gedea, the spin-off company that developed the pHyph innovation, recently cleared the final hurdle when the product received a CE mark from the EU. This means that it can be sold in Europe, and several retailers have shown interest.

The company was founded by Consultant Obstetrician and Gynaecologist Helena Strevens, Researcher in Chemistry Sophie Manner, Professor of Chemistry Ulf Ellervik, and the late Professor of Chemistry Olov Sterner, (who died earlier this year).

Next steps:
A CE marking means that the product is authorised to go on sale. However, for it to be sold to consumers, companies must buy the right to sell the product within a particular region. Several have already shown interest. The company is in active dialogue with established pharmaceutical companies about launching the product on the European market.

CE marking:
The product pHyph is classified as a medical device and not a medicine because, unlike medicines, it does not attack the pathogens directly. Instead, pHyph reinforces the original healthy environment in the genital area. pHyph is CE marked according to the Medical Device Regulation (MDR), which means that the product has been assessed as both safe and effective. The MDR replaces the previous Medical Devices Directive (MDD) and sets higher requirements for clinical documentation than most products currently on the market. 

Funding:
Investment from LU Ventures and several grants from Vinnova and Swelife, as well as from Fast-Track-To-Innovation (Horizon) and EIC Horizon Accelerator.