Lund, December 16, 2020: Gedea Biotech today announced that results from a recently published study show that their pHyph antibiotic-free treatment for bacterial vaginosis has a high cure rate and prevents recurrence of the infection.
Titled “A novel non-antimicrobial treatment of bacterial vaginosis: An open label two-private centre study” the results were published in peer-reviewed European Journal of Obstetrics & Gynaecology and Reproductive Biology. The clinical trial was run by Lund University Hospital, Sweden and the analysis of the data and the scientific writing has been done in collaboration with a research group at Nottingham University Hospital.
Taking advantage of new research technologies, follow-up investigation at the Karolinska Intitutet is now underway of microbiome samples collected during the study. This is expected to reveal additional insights into patient responses.
Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women, characterized by a dysbiosis or microbial imbalance of the vaginal microbiota. Signs and symptoms include an often profuse thin, white, “fishy” smelling vaginal discharge, in the absence of itching. Standard treatment consists of oral or topical vaginal antimicrobials, with cure rates of 80–90 % at 1 week, but recurrence rates of 15–30 % within 3 months. This results in women requiring repeated treatments, with a risk of developing antimicrobial resistance, and of disturbing the normal vaginal microbiota further. Antimicrobial resistance is one of the World Health Organization’s top ten threats to global health in 2019 and research into novel non-antimicrobial based treatments is timely.
The aim of this study was to investigate the clinical performance of pHyph, a new natural product-based treatment developed by Gedea, in an open label study for BV treatment and prevention of its recurrence.
Participants were adult women with confirmed BV according to fulfilment of at least three of the four Amsel’s criteria*. The primary outcome from the study was cure; defined as absence of the three, non-pH related Amsel criteria This is the most used and accepted definition of clinical cure for bacterial vaginosis.
28 patients were screened, 24 enrolled and treated. There were two withdrawals before data collection which leaves 22 patients who completed 7 days of treatment. Seven of the 22 patients suffered from recurrent BV defined as three or more infections in the past year. Women with recurrent BV had a higher cure rate of 86 % (6/7) than women with less than three episodes of BV in the past year.
This study has shown this novel BV treatment gives high short-term cures rates of 82 % (n = 18/22) at day 7, and low rates of recurrence at 14 days of 5.6 % (n = 1/18), with no additional recurrences reported at 35 days. The early cure rate is comparable with standard treatment cure rates of 80–90% at 7 days. Recurrence appears to be lower than standard of care at 5.6 % at one month compared to 15–30 % with standard of care at 3 months.
Dr Harriett Latham-Cork, Nottingham University, lead author of the study commented:
“The results are extremely promising and point towards this new treatment providing an effective alternative to current antibiotics. Of course,this would in turn contribute to fighting antibiotic resistance.”
Annette Säfholm CEO of Gedea Biotech added:
“Encouraged by these results we are now running a larger placebo-controlled, double-blind study with 150 patients in UK and Sweden and expect topline results in late 2021. In addition, we are taking advantage of exciting new advances in microbiome diagnostics to analyse samples from the study at the Karolinska Institutet in Stockholm.”
The clinical study included microbiome samples at day 0, 7 and 35 and they are being analysed by Karolinska Institutet:
Centre for Translational Microbiome Research (CTMR).
“The microbiome samples from this clinical trial add new data to the field of microbiome research,” says Ina Schuppe at KI. “At KI, we can make a comparison between the microbiomes from these patients with BV with microbiomes from healthy women. It will probably provide us with information about how the treatment impacts the microbiome and also the role of the microbiome in treating and preventing bacterial vaginosis.”
* Amsel criteria: Vaginal discharge, Clue cells, Fishy odour, pH above 4.5
Lund, Sweden, October 27, 2020. Gedea Biotech,today announces that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with 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 will be coordinated by Nottingham University NHS Hospitals Trust in the UK.
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 and is due to start in October 2020. The primary objective is to investigate clinical performance of pHyph – in a smaller study reported earlier this year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days. This corresponds to existing antibiotic-based treatment. After the first treatment period (day 0-7), patients that are cured 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 microbiome.
“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: “This larger trial will be pivotal in demonstrating that pHyph can provide an effective and longlasting 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
The ISO-certificate is a part of the company’s development towards a CE-marking of a product. Therefore, the ISO certificate is a very important step towards CE marking of pHyph, ensuring that Gedea´s quality management systems in design, development, marketing, distribution and production are sufficient.
Annette Säfholm, Gedea Biotech’s CEO comments: “I am delighted that we have now reached this important milestone as planned. The certification is a major step forward towards CE marking and launch of our vaginal tablet, pHyph for treatment of bacterial vaginosis. Gedea plans to apply for CE marking of pHyph, according to MDR, during 2020.”
There is currently a noticeable shortage of notified bodies designated for the new EU regulation MDR (Medical Device Regulation) and many medical device companies are struggling to have their products approved in time. Gedea chose to work with Tüv Süd over two years ago, as Tüv Süd was one of the first notified bodies to become designated for MDR.
Lund, Sweden, March 11, 2020. Gedea Biotech, an innovative women’s health company today reported results from a clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). In this open-label, single-armed, multi-center study, 82% of the women were clinically cured after 7 days. The cure rate corresponds to existing antibiotic-based treatment. Bacterial vaginosis (BV) is the most common vaginal infection with a prevalence of 10–29% in the whole female population and rising up to 50% in pregnant women (1,2,3). The symptoms of BV include a vaginal discharge, a fishy odour and sometimes a burning pain. It can affect and limit many aspects of daily life. Gedea wishes to caution however, that whilst these results are highly promising, further studies are needed to confirm results. Larger studies including recurrence data are being planned.
The vaginal tablet, pHyph acts by restoring the patient’s pH to its normal level of pH 4,0 - 4,5 which is optimal for the protective lactobacilli pHyph also breaks down the biofilm formed during bacterial vaginosis in which the infectious bacteria begin to thrive. The naturally occurring active ingredient GDA 001 in pHyph has a well-documented safety profile and is already approved as a food additive.
The pHyph study* enrolled a total of 24 patients each of whom met at least three of the four Amsel criteria – a thin white yellow homogeneous discharge; clue cells on microscopy; a pH of vaginal fluid > 4.5 and release of a fishy odour on adding alkali. Patients were treated with pHyph for one week and primary endpoints were the clinical cure rate at Day 7 as well as safety and tolerability data. Patients were aged 18-49 and the median age was 33. In the Full Analysis Set (FAS, n=22) a total of 18 women (82%) were clinically cured, as defined by the absence of all the three Amsel criteria. Recurrence numbers at day 35 were found to be very low.
“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is need for new, effective treatments not involving antibiotics. The results of this study are promising and may lead to a much-needed treatment alternative”, says Dr. Monika Cardell, MD and senior consultant in obstetrics and gynecology at Skåne University Hospital, Lund. Dr. Monika Cardell was also the Principal Investigator of the clinical trial.
Annette Säfholm, Gedea Biotech’s CEO comments: “These results for pHyph are indeed highly promising, showing effectiveness equivalent to antibiotics in treating bacterial vaginosis. The cure rate and recurrence numbers gives us strong confidence to continue our pHyph program and to confirm the results in upcoming studies.”
*Details of the clinical trial can be found at here
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In 2019 Gedea gained good traction in media, both Swedish and international. Rapidus, BioStock, Life Science Sweden, Läkemedelsmarknaden and other Swedish business/medtech media published articles about us. American BioSpace published no less than three press items on Gedea. We are happy to now "be on their radar".
From BioSpace Dec 13, 2019:
Gedea Biotech – Gedea Biotech received €3 million from the EU program Fast Track to Innovation to fund completion of the clinical trial program and preparation work for market introduction of the company’s antibiotic-free treatment for vaginal infections. Vaginal infections are a common problem and current treatments such as antibiotics are not always effective. Collaboration partners for the work are the CRO company Link Medical from Norway with whom Gedea Biotech has a long-standing relationship and the University of Nottingham Hospitals, home to the lead clinic for the work.
We look forward to 2020 together!
Vaginal infections are a common problem, and current treatments such as antibiotics are not always effective. According to FTI, the justification to select Gedea Biotech as a recipient of the funding is based on, not only the significant medical need, but also on the resultant opportunity to replace current treatments involving antibiotics. Several strains of bacteria and fungi are already resistant to current treatments.
Annette Säfholm, CEO at Gedea Biotech, comments: “We believe that our new treatment, which has already shown promising results in a recently finalized clinical study in patients with bacterial vaginosis, will benefit both patients and healthcare. We are therefore delighted to have received this funding enabling us to launch the product earlier than otherwise would have been the case. We now look forward to initiating the work on our next clinical trial in Europe, together with our partners in Norway and the UK. We expect to launch our first product, that treats and prevents bacterial vaginosis in 2021.”
Collaboration partners for the work are the CRO company Link Medical from Norway with whom Gedea Biotech has a long-standing relationship and the University of Nottingham Hospitals, home to the lead clinic for the work.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 878775
The world urgently needs to change the way it prescribes and uses antibiotics. Even if new medicines are developed, without behaviour change, antibiotic resistance will remain a major threat. Behaviour changes must also include actions to reduce the spread of infections through vaccination, hand washing, practising safer sex, and good food hygiene.
All patients treated in Swedish women’s health company Gedea Biotech’s pHyph proof of concept study in women with bacterial vaginosis
Lund, Sweden, October 31, 2019. Gedea Biotech, an innovative women’s health company today reports that all 24 patients have been treated with its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis in a proof of concept clinical study. In this open-label, single-armed, multi-center study, promising results have been seen when it comes to clinical performance, tolerability, and safety. Final results of the trial are expected to be ready by the end of the year.
The vaginal tablet, pHyph acts by breaking down the biofilm formed during bacterial vaginosis under which the infectious bacteria begin to thrive. This restores the patient’s pH to its normal level of pH 4,5. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive.
“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is a need for new, effective treatments not involving antibiotics. The results of this study are promising and may lead to a much-needed treatment alternative”, says Dr. Monika Cardell, MD and senior consultant in obstetrics and gynecology at Lund University Hospital. Dr. Monika Cardell is also the Principal Investigator of the clinical trial.
Annette Säfholm, Gedea CEO comments: “We are delighted to report that we already see promising results when it comes to efficacy of this treatment for which we have a use patent, of bacterial vaginosis intended to be curative. Furthermore, tolerability and safety were both excellent. We now look forward to analyzing and reporting the results later this year.”
Details of the clinical trial involving 24 patients at two sites in Sweden can be found here
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
About bacterial vaginosis
Bacterial vaginosis is the most common vaginal infection in women of reproductive age and is a disease of the vagina caused by excessive growth of bacteria producing an imbalance of the naturally occurring bacteria in the vagina. The condition is treated with antibiotics and/or antiseptic treatment products. Recurring bacterial vaginosis is common.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, an antibiotic free and effective treatment of bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. In addition to developing a treatment of bacterial vaginosis, Gedea Biotech is currently also pursuing a clinical trial with pHyph in patients suffering from fungal vaginal infection. Gedea Biotech was founded in 2015 in Lund, Sweden.
Gedea Biotech will participate in RCOG's World Congress in London, June 17-19. Marketing Manager Eva Norell will participate and she is responsible for Gedea´s market insight:
- We keep up-to-date with both the medical development in vaginal infections and we listen to what doctors and patients really need. A large congress, like this. gives opportunities to meet doctors from many different countries and different health care systems, says Eva Norell.
Gedea Biotech is currently closing two clinical studies on bacterial vaginosis and vaginal candidiasis. The next step is a CE marking of the product pHyph and then launch in Europe.
- It is important that of doctors, nurses and midwives feel confident about the effect of pHyph and the mechanism of action of the product when it is used, says Eva Norell.
Gedea has received SEK 3 million Swelife and MedTech4Health. Gedea applied for the grant to verify, in collaboration with Region Skåne, the effect of pHyph in a larger placebo-controlled clinical trial for a market launch in Europe. Swelife and MedTech4Health are part of Vinnova, the Swedish Energy Agency and Forma's joint venture on strategic innovation programs.
Read full article here
Gedea Biotech works for women's health through the treatment of pelvic infections. We want an openness about this health problem at the health seeker, at workplaces or among family and friends. Most people know someone who suffers from a pelvic infection and wants to be able to support their loved ones in a good way.
Read the full article from WHO Celebrating Women
Gedea Biotech won the prize money of € 10,000 for the third prize and received € 10,000 for being chosen for the audience's favorite, thus winning as much as the first prize winner, a total of € 20,000. The audience award became a landslide victory for Gedea. There was only one award for all the categories and Annette Säfholm and Gedea won by far over the other 11 companies. 350 people out of 400 participated in the voting and Gedea won.
- Vaginal infections are painful and there is a huge need for new, modern solutions. I think the audience voted for us because our product, pHyph, solves a problem that is urgent for many people, says Annette Säfholm.
-Participation in EIT Health Catapult has given us in valuable contacts with investors, entrepreneurs and partners that we will benefit greatly from in the future," says Annette Säfholm
Gedea Biotech is based on research at Lund University of Olov Sterner, Sophie Manner and Ulf Ellervik at Chemistry Center together with Helena Strevens, senior doctor in gynaecology/obstetrics at the Women's Clinic at SUS. The first two clinical studies are ongoing in patients with vaginal fungal infection and bacterial vaginosis.
About EIT Health: Together for healthy living in Europe
Gedea has been granted SEK 500,000 in appropriations from the SME Instrument phase 1 program within the EU Horizon 2020 framework program. The Horizon 2020 program is competitive and only a few percent of all grant applications are granted.
- The grant from Horizon 2020 is both an important funding that enables us to maintain momentum and also an acknowledgement of the qualities of the company. We are very proud to receive the grant in such tough competition, says CEO Annette Säfholm.
Horizon 2020 is the EU's largest research and innovation program with nearly 80 billion euros in funding, available for 7 years (2014-2020). The program emphasizes high-quality science, industrial management and meeting social challenges. The goal is to ensure that Europe produces world-class science, removes barriers to innovation and facilitates the public and private sector to work together for innovation.
Last week, the Medical Products Agency and Ethics Committee announced that they approved Gedea's first clinical study. The study is an important step towards CE marking of pHyph, which is a completely new type of treatment of vaginal infections. pHyph is expected to to treat both vaginal fungal infection and bacterial vaginosis and to become the first product on the market for the treatment of both infections.
In the study, patients with vaginal fungal infection will be treated with vaginal tablets of pHyph. The study is expected to start in late October. The aim of the study is to investigate the clinical effect of pHyph on the infection and to ensure that patients experience the treatment as user-friendly.
Today's treatments are often insufficient as they are either insufficiently effective or inadequate treatment, since the symptoms of bacterial and fungal infection may be similar.
- The study is a very important milestone for Gedea. We are very pleased that we can start the study as planned, says CEO Annette Säfholm. There are many, both within Gedea and our partners who have worked hard to get started with the study. It has been an extensive work.
Clinical results will form the basis for a CE marking later on.
The study is conducted at two gynecologist receptions in Skåne: Hoftekliniken in Helsingborg and Annerokliniken in Hofterup. Patients who have vaginal fungal infection will be asked if they want to participate in the study and try a new treatment. The study is estimated to last for three months and 24 patients will be included in the study. The study is conducted in cooperation with the Region Skåne and the Clinical Examination Unit at Lund University Hospital.
Later this fall, Gedea plans a further clinical study in which patients with bacterial vaginosis will be treated with pHyph.
- pHyph is expected to treat both vaginal fungal infection and bacterial vaginosis and thus becomes the first product on the market for the treatment of both infections. This reduces the risk that patients choose the wrong treatment for their infection, says Annette Säfholm.
About Smile Incubator
Gedea Biotech is a company in SmiLe Incubator, a business incubator in life science that helps entrepreneurs to commercialize their ideas, offering business advice, well-equipped laboratories and a large network.
Gedea Biotech has reached the final at European Health Catapult, a European startup competition. In tough competition by really strong companies, Gedea went on to the final in Lodz in December. Out of the 14 who reached to the semifinal, seven went on and Gedea is one of them. Another company from Smile Incubator; Sinntaxis also reached the final.
- Reaching the final shows that Gedea is a company with a really good idea and great potential. We are close to market and that is probably an advantage for us in the competition, says Annette Säfholm, CEO of Gedea.
The competition is organized by the EU to find the best European innovations in health, and support them in their commercialization. In the finals there are investment events and prize money.
Last Wednesday, Gedea Biotech won a shared first place and Akuru Pharma a third, in the pitch competition "Startup Challenge" at NLSDays, the Nordic region's largest partnering fair in life science. It is the second consecutive year that SmiLe companies take top positions in the competition.
Read full article here
Read full article here.
Serendipty Challenge web site.