LINK Medical and Medaffcon join forces in Real World Evidence (RWE) and Market Access

UPPSALA, Sweden, February 2, 2021 – LINK Medical, the Northern European clinical research
organization (CRO), and the Swedish women’s health company Gedea Biotech announced today that it has enrolled the first patient in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK and LINK Medical.

Bacterial vaginosis is a vaginal infection with a prevalence of 10-30% in adult women. The infection causes disturbing symptoms that affects daily life in many ways. NEFERTITI aims to recruit 150 adult women aged 18 or over with bacterial vaginosis diagnosed by Amsel’s* criteria. The primary objective is to investigate clinical performance of pHyph. After the first treatment period (day 0-7), patients that are cured (a high cure rate is expected based on a previous smaller study), will be randomized to preventive treatment, and given one tablet a week of pHyph or placebo, for four months. The follow up period will provide important data on pHyph´s impact on prevention of recurrent infections and the effect on the vaginal microbiome. Patients in the UK and in Sweden will be enrolled in the NEFERTITI study.

“LINK Medical is proud to be a strategic partner, supporting Gedea in improving their strategy which has helped with the planning of their clinical trials as well as to get funding from the EU program Fast Track to Innovation (FTI), part of Horizon 2020. Today we celebrate reaching another very important milestone after a year overcoming challenges with Covid-19. With 4 sites in the UK and 3 sites in Sweden we are ready to get this clinical trial running with a great team. We are looking forward to positive results in this transformational treatment for women” says Ola Gudmundsen.

“I am delighted to lead the NEFERTITI study as the Chief Investigator,” commented Dr Kate Walker, Clinical Associate Professor in Obstetrics, University of Nottingham. “Bacterial vaginosis is a very common vaginal infection, affecting 1-2 in every 10 women, caused by an overgrowth of unhealthy bacteria in the vagina.  We have standard antibiotic treatments which work really well in the short term, but there is a very high rate of recurrence.  This results in women having to take multiple courses of antibiotics which contributes to the global problem of bacteria becoming resistant to antibiotics.  It would be a major step forward to have a non-antibiotic treatment that cures women and prevents recurrence.  That’s why I’m so excited about the NEFERTITI trial as we may have found such a new treatment.  It’s really important to do the study properly and check the treatment is effective and acceptable to women.”

Annette Säfholm, Gedea Biotech’s CEO comments: “In a smaller study reported last year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days, thus corresponding to the outcome of existing antibiotic-based treatment. This larger trial will be pivotal in confirming that pHyph can provide an effective and long-lasting treatment alternative to antibiotics.”

*Diagnose of bacterial vaginosis according to Amsel criteria is at least three of the following criteria – thin white homogeneous discharge, clue cells on microscopy, pH of vaginal fluid above 4.5. and release of a “fishy” odor.

For further information, please contact:

Annette Säfholm,

CEO Gedea Biotech

Telephone: +46 708 – 91 86 81

Email: annette.safholm[@]gedeabiotech.com

 
Olov Sterner,

Chairman Gedea Biotech

Telephone: +46 705- 30 66 49

Email: olov.sterner[@]gedeabiotech.com