Gedea Biotech awarded SEK 3M from SWElife and MedTech4Health for groundbreaking antibiotic free women’s health trial
Impact on microbiome could be key to preventing vulvovaginal infection recurrence
Lund, Sweden, April 4, 2023: Gedea Biotech today announced it has been awarded SEK 3M grant from the Swedish innovation programs, SWElife and MedTech4Health in a collaboration with Danderyd hospital, Huddinge hospital and Karolinska Institute, to fund a further clinical trial of its antibiotic free treatment pHyph for the treatment of vulvovaginal candida infections (VVC).
Vaginal infections affect at least 400 million women worldwide every year, but with current treatments, the risk of recurrence is substantial as antimicrobial resistance also rapidly increases. pHyph has shown a clinical cure rate for bacterial vaginosis on par with antibiotics on the market, - with a superior safety profile and without causing secondary VVC infections as is the case with antibiotics. The new study, involving 26 patients with VVC to be recruited at four clinics in Sweden, will also analyse the impact the treatment has on the vaginal microbiome which is believed to play a key role in how pHyph treats and prevents recurrence of vaginal infections. Results are expected during the autumn 2023.
"We are delighted to receive this grant from SWElife and MedTech4Health, an investment that is particularly welcome given that women's health is a neglected area," says Annette Säfholm, CEO of Gedea Biotech. "The study, which aims to confirm the safety and efficacy of pHyph in the treatment of vulvovaginal candidiasis (VVC), also focuses on analyzing how the vaginal microbiome - believed to play a key role in preventing recurrence - is affected by the treatment".
For more information
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com
Ton Berkien, Chairman, Gedea Biotech
Telephone: +46 70- 791 49 54
Email: ton.berkien@gedeabiotech.com
About pHyph
The vaginal tablet, pHyph will treat bacterial vaginosis (BV) and prevent recurrence by promoting a healthy vaginal microbiome, restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during BV under which the infectious bacteria begin to thrive. These mechanisms of actions, together provide a beneficial environment for the healthy vaginal microbiome. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive. A clinical cure rate for BV on par with antibiotics on the market, has been proven in two phase 2 trials, with a superior safety profile and without causing secondary VVC infections as antibiotics do.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that will both treat and prevent bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. Gedea Biotech was founded in 2015 in Lund, Sweden. https://gedeabiotech.com/
Medtech4Health
Medtech4Health strive to increase the number and quality of new innovative products and services within medtech. In collaboration with patients, healthcare, academia, and business, we contribute to increasing value for people affected by disease in their everyday lives. Medtech4Health is funded by the Swedish government through the Swedish innovation authority Vinnova, Swedish Energy Agency and Swedish Research Council for Sustainable Development Formas, and by the programme’s partners. www.medtech4health.se
#innovation #medtech #medicinteknik #hälsa #health @medtech4health @swelife @vinnova
Swelife
Swelife – For a competitive life science ecosystem in Sweden
Swelife is a strategic innovation programme, funded by the Swedish Government via the Swedish innovation authority Vinnova, Swedish Energy Agency and Swedish Research Council for Sustainable Development Formas, and by the programme’s partners, and by the programme’s partners. We support collaboration within academia, industry, and healthcare, with the goal to strengthen Life Science in Sweden and to improve public health. www.swelife.se.
