Gedea Biotech granted European Patent for its treatment pHyph for women with vaginal fungal infections

PRESS RELEASE 

Lund, Sweden, October 25, 2021. 

Patent now valid in two of the world’s largest markets, Europe and USA until 2037

Swedish women’s health company Gedea Biotech today announced that the company has been granted a patent from the European Patent Office, covering the treatment of fungal infections with compound glucono-δ-lactone (GDL). The patent numbered EP 3 439 633 is valid in 36 European countries and can be kept in force until the 6th of April 2037. This follows previously announced patent rights valid in United States. Gedea Biotech has previously announced that the corresponding patent is approved in the USA. Both patents comprise the use of the ingredient GDL in pHyph. GDL is a well-documented substance with a low risk of developing resistance.

Half way into Gedea Biotech’s NEFERTITI clinical trial of pHyph antibiotic-free treatment of bacterial vaginosis 

Nefertiti logo liten Lund, Sweden, September 8, 2021, 2021. Swedish women’s health company Gedea Biotech today announced that it has enrolled more than 50% of patients 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 the safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK.

Bacterial vaginosis is the most common vaginal infection and affects around 10-30% of women of reproductive age. It is a condition of the vagina caused by excessive growth of bacteria, resulting in an imbalance of the naturally occurring bacteria in the vagina and disturbing symptoms that affect daily life in many ways. The condition is treated with antibiotics and/or antiseptic treatment products but recurring bacterial vaginosis is common. Approximately 8 million prescriptions of antibiotics are currently issued each year for BV in the US and in the EU combined.

“The team of investigators are putting tremendous effort into recruiting patients, and I am delighted to see the progress we are making,” says Dr Kate Walker, Clinical Associate Professor in Obstetrics, University of Nottingham and principal investigator for the study. “We have standard antibiotic treatments for bacterial vaginosis which work 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 antibiotic resistance. A non-antibiotic treatment that prevents recurrence would therefore be a major step forward.”

Annette Säfholm, Gedea Biotech’s CEO comments: “We are conducting the NEFERTITI study to confirm the previous positive results of pHyph in the treatment of bacterial vaginosis and to evaluate the long-term effect of pHyph. Thanks to superb efforts by investigators in Sweden and England, we have come halfway into the study, despite the very difficult conditions for recruiting patients for studies right now.”

Gedea Biotech granted US patent for its antibiotic-free treatment pHyph for women with vaginal fungal infections

Lund, Sweden, August 31, 2021. Swedish women’s health company Gedea Biotech today announced that it has been granted a patent (US 10,993,907) by the United States Patent and Trademark Office (USPTO) for thetreatment of fungal infections by the company’s compound glucono-δ-lactone (GDL). The patent can be kept in force until 2037.

Progress in the clinical trial for bacterial vaginosis

Martin StjernquistNow, 57 patients, patients have been enrolled in the NEFERTITI clinical trial. Thanks to persistent and inventive investigators, in Sweden and in England, the study progresses at a steady pace. The NEFERTITI study examines the clinical effect of Gedea's treatment of pHyph in bacterial vaginosis, both as a treatment and prevention of recurrent infections. 150 patients will be included and 25% of them will receive placebo treatment during the first 7 days of the study. After 7 days, patients who have been cured will be re-randomized to a follow-up period of 18 weeks where 50% will receive placebo and 50% will receive pHyph, 1 tablet per week.
 
Martin Stjernquist is a gynecologist at a clinic in Malmö and investigator in the study:
- Many women have problems with bacterial vaginosis, which often involves foul-smelling discharge. It is a major problem for those affected and the infection often reoccurs. This study is important because it can lead to new treatment options that reduce the risk of recurring symptoms.

Sten Kornfält, clinical project manager at Gedea, says that the investigators in the NEFERTITI study show great commitment:
- We see that the investigators care very much for their patients and want to contribute to developing a new treatment of vaginal infections.
 
The clinic in Malmö has so far recruited the most patients for the study and Martin Stjernquist believes that the clinic's teamwork is a success factor:
- The study nurse calls the patients before the visit and asks some questions to ensura that the study is right for the patient.
Women who are interested in participating in the study can register their interest via this link https://www.link2trials.se/forsoksperson-kliniska-studier/klinisk-studie-for-bakteriell-vaginos/show/730

First patient enrolled in Gedea Biotech’s NEFERTITI Clinical Trial of pHyph for antibiotic-free treatment of women with bacterial vaginosis

PRESS RELEASE 2021-02-01

Lund, Sweden, February 2nd, 2021. Swedish women’s health company Gedea Biotech today announced 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. The NEFERTITI study is financed by the EU program Horizon 2020 and run by the consortium partners Nottingham University NHS Hospitals Trust, LINK Medical and Gedea Biotech.

Gedea on Top 21 list

Labiotech.eu is the leading online media for the biotech industry in Europe. Gedea Biotech is the only Swedish company on Labiotech's annual list  "The 21 European Biotech Companies to Watch in 2021". Labiotech has run articles about Gedea several times, focusing on our ambition to develop a treatment that not only treats but also prevents recurrence of bacterial vaginosis and provides a true alternative to antibiotics.

Gedea’s pHyph antibiotic-free treatment shows high cure rate and low risk of recurrence in bacterial vaginosis in published study

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Follow-up study of Microbiome samples now underway at Karolinska to provide further insights

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.

Gedea Biotech receives MHRA approval to initiate NEFERTITI Clinical Trial in the UK of pHyph for antibiotic-free treatment of women with bacterial vaginosis

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

Gedea Biotech gains ISO 13485: 2016 certification in preparation for CE marking and launch of antibiotic-free bacterial vaginosis treatment

ENISO 13485 Q 3D NLund, Sweden, April 7, 2020. Gedea Biotech, an innovative women’s health company today received its certificate in accordance with ISO 13485: 2016 (Medical devices - Quality management system - Requirements for regulatory purposes). The scope of the certificate includes design, development,marketing, distribution and production of antibiotic-free vaginal tablets intended to treat bacterial vaginosis. The certificate has been issued by TÜV SÜD, an accredited notified body.
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.

82 % clinically cured in antibiotic-free treatment trial in women with bacterial vaginosis

PRESS RELEASE

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

International Women´s Day 2020

This year´s International Womon´s Day, Gedea wants to support UN Women´s campaign “I am Generation Equality: Realizing Women’s Rights”.
The Generation Equality campaign is bringing together people of every gender, age, ethnicity, race, religion and country, to drive actions that will create the gender-equal world we all deserve.

One of Gedea´s  Sustainable Development Goals is Equality. Good Health improves  women and girl´s possibilities to participate in society.

Read more about UN Women here


Intl womens day 2020 UN Women

Media coverage 2019

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".

 

Here is a selection of press items

BioSpace Dec 13, 2019 read
BioSpace Dec 26, 2019 read
BioStock Dec 19, 2019 read

From BioSpace Dec 13, 2019:

BioSpaceGedea 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.

 

 

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Merry Christmas

In 2019, we conducted two clinical studies, developed the quality system, moved into new premises, received grants from SweLife and as a fantastic end to the year we could tell that we were granted 3 million Euro by the EU Horizon 2020. 

We look forward to 2020 together!
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Swedish women’s health company Gedea Biotech awarded €3 M by EU’s Horizon 2020 to accelerate introduction of antibiotic-free treatment for vaginal infections

EU emblem HRGedea Biotech today announced that it has received €3 M from the EU program Fast Track to Innovation (FTI), part of Horizon 2020. The grant will fund completion of the clinical trial program and preparation work for market introduction of the company’s antibiotic-free 
treatment for vaginal infections. Partners in the program are Link Medical Research in Norway and Nottingham University Hospitals in the UK.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.

For further information This email address is being protected from spambots. You need JavaScript enabled to view it., CEO Gedea Biotech
This project has received funding from the  European Union’s Horizon 2020 research and innovation programme  under grant agreement No 878775



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Antibiotic Awareness Week 2019

Gedea is spreading the message from the WHO:s Antibiotic Awareness Week 2019. 

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 proof of concept study in women with bacterial vaginosis


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
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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. 

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www.smileincubator.life   www.innovation.lu.se

Gedea attends Royal College of Gynecology and Obstetrics World Congress

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.

For further information, please contact Eva Norell at This email address is being protected from spambots. You need JavaScript enabled to view it.

Gedea receives SEK 3 million in Vinnova grants

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
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International Womens Day

Women's health is both a health issue and a gender issue. At the International Women's Day, WHO draws attention to important efforts in research and health, for and by women. Health issues have a huge impact on women´s possibilities to patyiciapte in sociaty and working life. 

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 third prize in European competition

Gedea Biotech won third prize in the European Final of the EIT European Health Catapult, in the category of Biotech. Gedea also won the Crowd Award! This means that the company is one of Europe's absolute best start-up companies in the health sector. After months of a preparations and competitions, the final took place on December 4 at the EIT Health Summit in Poland Lodz.

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
EIT Health is a European network with over 140 qualified partners from industry, academia and healthcare professionals in Europe. Region Skåne is one of the main partners since 2018, which allows companies with relationships with the regional innovation system to seek funding for international growth. Innovation Skåne coordinates the program in the region. For more information, see eithealth.eu or contact This email address is being protected from spambots. You need JavaScript enabled to view it.
kartaGedea Biotech AB
Medicon Village
Scheeletorget 1
223 81 Lund
Sweden
Annette Säfholm, CEO
annette.safholm@gedeabiotech.com
+46 (0) 708 - 91 86 81

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