Ten years ago, the four founders of Gedea Biotech—Olov Sterner, Ulf Ellervik, Sophie Manner, and Helena Strevens—registered the company to develop an innovative treatment for vaginal infections. In 2016, Annette Säfholm was appointed CEO, the company was renamed Gedea, and its activities quickly gained momentum.

Since then, Gedea has conducted five clinical trials focused on bacterial vaginosis and vulvovaginal candidiasis, yielding convincing results. Over the years, we have won numerous prizes and awards, secured grants, and received remarkable support and trust from our shareholders.

Thank you all for support, collaboration and much fun!

 

Here's a celebration video . 

On Thursday November 28th, at the Nordic Mentor Network For Entrepreneurship - NOME annual meeting in Copenhagen, we were honored to receive the Arvind Hundal Scale-up Award for “showing inspirational growth.”
We are proud, humbled, and truly grateful for this recognition. Following in the footsteps of last year’s winner, Neola Medical, is a privilege and an inspiration.
As a NOME alumni, Gedea has benefited immensely from access to world-class mentors with deep expertise in international pharma and medtech. Their honest, insightful, and encouraging guidance provided a valuable outside-in perspective, helping us grow and refine our business.
We wholeheartedly recommend the NOME program to other companies looking to scale and thrive.

Annette Säfholm and Eva Norell received the award in Copenhagen and was joined for a picture by three of our NOME mentors Morten Faester, Søren Anker Nielsen and Kirsten Söndersted-Olsen.

Emilia Lahtinen is an industrial Ph.D. student at Gedea and at Karolinska Institutet. Her project has the title Bacterial vaginosis: Understanding the impact of antibiotic and antibiotic-free treatments on the vaginal microbiome and risk of recurrence. Please meet her in this short interview.

You have been an industrial Ph.D. student since 2022, a position shared between Gedea and Karolinska Institutet. Was this your dream project?

Yes, absolutely! I knew I wanted to work with bioinformatics, microbiome research, and be close to, or within the industry. As an industrial doctoral student, you can conduct research that is not only likely to be applied but also contributes to the general body of knowledge.

What is your affiliation at Karolinska Institutet?

I am located at the Centre for Translational Microbiome Research (CTMR). I am fortunate to have an excellent supervisory team guiding my research. My main supervisor, Ina Schuppe Koistinen, PhD, is based at CTMR, where two of my co-supervisors are also affiliated. Additionally, I am supervised by Helena Strevens, MD, PhD, from Gedea Biotech.

What difference can your research make to women or in the field of women’s health?
The research field is relatively new, as historically women’s health has been underrepresented in medical research, and there is much to learn. Expanding our knowledge about the vaginal microbiome will help us to understand the underlying causes of conditions like bacterial vaginosis and guide the development of more effective, targeted treatments.

What do we know about the vaginal microbiome to date? Is there a common understanding of what constitutes a healthy microbiome and what does not?

A clear causal link between specific microbiome composition  and the symptoms experienced by women has not yet been established. Historically, infections have been attributed to specific pathogenic microbes, with the assumption that eliminating them resolves the problem.  But it's not that simple. The microbiome’s function is influenced by the dynamic interactions within and between microbial communities. The vaginal microbiome also varies significantly across different stages of life. Factors, such as pregnancy, childbirth, menopause, and hormonal changes can all affect the microbiome. Ethnicity also plays a role in microbiome diversity, though it is unclear whether this is due to differences in lifestyle, genetics, or immune system responses. One established observation, however, is that a microbiome dominated by Lactobacillus crispatus is associated with good health while a microbiome with a high microbial diversity is associated with various gynecological conditions and adverse pregnancy outcomes.

The research field is relatively new. Why is it that this knowledge, which is important for women’s health, has not been explored earlier? Is it due to a lack of interest, resources, or access to the right technology?

Probably all three of them. We use shotgun sequencing to process large datasets, and advancements in sequencing technology have undoubtedly propelled microbiome research forward. Before this, methods like 16S rRNA sequencing were used to identify many microorganisms that couldn’t be cultivated in the lab, but they had limitations in resolution and scope. The development of sequencing technology has been essential for identifying and characterizing microorganisms on a large scale. Many areas of women’s health research  have struggled with the lack of resources and interest, which is why the research frontier is now advancing rapidly. It’s fantastic to be part of groundbreaking research!

What is your next milestone?

Next year, my goal is to publish results related to Gedea’s CL3-study (NFERTITI) study, where I studied the changes in the vaginal microbiome of patients who were treated with pHyph. That’s exciting!

At CTMR, we also have a mission to engage with the public and share our knowledge. We have an Instagram account called @fembiome where we post “fact-based science about the vulva, vagina and their microbes”. Follow us to dive deeper into the world of microbes and their impact on women’s health!

Gedea Biotech AB carried out a rights issue of SEK 24.3 million during October. The interest from both existing owners and new investors exceeded the board’s mandate, and an extraordinary general meeting resolved a directed issue to include the oversubscription of SEK 13 million. In total, Gedea has after issue costs received SEK 34.8 million.

 Earlier this year, Gedea received a €2.5 million grant from the Horizon 2020 EIC program, which provided a EU quality stamp to our program efforts. Strengthened by this EU support, the company is now finalizing the CE marking process according to the Medical Device Regulation (MDR) for getting European approval for pHyph. Supporting the approval in Europe we will launch project activities to transfer our technology to commercial-scale production, as well as advancing partnership efforts for the development and commercialization of pHyph.

Based on clinical results from the European registration study for bacterial vaginosis together with a strong financial situation and a runway exceeding 24 months, Gedea´s position in the partnering process is strengthened. 

 Annette Säfholm, CEO of Gedea Biotech comments: “Gedea is making progress, and we are delighted by the support from both current owners and new investors. We are excited about the next steps in our journey and the potential impact pHyph can have on the lives of millions of women.”

 Chairman of the board Ton Berkien adds: “We have extended our runway beyond the CE-marking process, technology transfer and partnering process which gives us a very strong position to commercialize pHyph with the support of a partner. I congratulate Annette and her team for the tremendous efforts made and I would like to thank our present and new investors for their strong support in Gedea.”

For further information, please contact: 

Annette Säfholm, CEO Gedea Biotech 

Phone: +46 708 - 91 86 81 

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

 Ton Berkien, Chairman of the Board, Gedea Biotech 

Phone: +46 70- 791 49 54 

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

S.A.B Corporate Finance and Jensen Corporate Finance supported the capital raise which attracted several new strong investors, whereas we received continued support from existing investors; family offices and high net-worth individuals with track records in the life sciences. 

About Gedea Biotech 

Gedea Biotech develops pHyph, an antibiotic free vaginal tablet for the treatment and prevention of bacterial vaginosis, estimated to reach EU approval in 2025. Further development towards US approval as an Rx-treatment is planned to be initiated in partnership. Gedea also has a pipeline with indications for vulvovaginal candidiasis and prevention of pre-term birth.

Globally, over 300 million women experience an episode of bacterial vaginosis, every year. The prevalence is estimated to 23% to 29% in the female population in reproductive age. The most bothersome symptom is excessive discharge with fishy odour, which is extremely stressful and affects all aspects of life. Today, patients are treated with antibiotics which have a fairly high short-term cure rate but leads to recurrence for 23-46% of patients within 35 days from start of treatment. Treatment with antibiotics also leads to a secondary vaginal fungal infection for up to 17% of the patients within 30 days.

 Gedea Biotech was founded in 2015 in Lund, Sweden, by four researchers from Lund University and Skåne University Hospital.

 About pHyph

pHyph is a vaginal tablet for treatment of bacterial vaginosis. Treatment with pHyph has shown significant results in cure rate and symptom relief. The safety profile is excellent and the recurrence rate is much lower than for standard of care. As a modern treatment for bacterial vaginosis, pHyph strengthens the microbiome to treat the infection and to boost resilience to recurrent infections. Conventional antibiotic treatment for bacterial vaginosis (BV) negatively affects the vaginal microbiome, which reduces resilience to new infections. Two clinical trials have verified that pHyph meets pressing medical needs for women with BV; rapid relief of fishy smell, long-term effect with low risk of recurrence and no risk of secondary fungal vaginal infection. 

 

This project is supported by the European Innovation Council

The European Innovation Council is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations The EIC has been established under the EU Horizon Europe programme. It has a budget of €10.1 billion to support game changing innovations throughout the lifecycle from early stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs.

 

We are pleased to announce that Per-Ola Forsberg has been appointed as the new CFO of Gedea since April 20th. Per-Ola holds a degree in business adminsitration from Lund University and has over 25 years of experience in the life science industry. His previous roles include CFO positions at Pharmiva AB, WntResearch AB, Idogen AB, LIDDS AB, Lund University Bioscience, and Probi AB. At Probi, he served as Vice President for the last two years, overseeing the company's business operations. Together with his wife Karin, Per-Ola also runs Rapidsrock, a show jumping stable where they breed and train horses at an international level.

 -When working in life science, one has the privilege of taking products from development to the pharmacy shelf, improving health and quality of life for people, says Per-Ola Forsberg. I am always engaged in the company's operations and business development, not just accounting and financing. There are many factors that contribute to a company's value. Building a strong brand is extremely important, for example.

 -What is known as femtech is very hot internationally, and I also find it to be an exciting area. Gedea is an interesting femtech company with great commercial potential. Annette Säfholm is doing a very good job with Gedea, and I look forward to working with her.

 -Per-Ola Forsberg has solid experience in life science and in many aspects of the business; business development, financing, and production, to name a few. I am really looking forward to working with Per-Ola," says Annette Säfholm, CEO of Gedea.

PRESS RELEASE

Yesterday, the EIC announced that Gedea Biotech has been selected for the €2.5M EIC Accelerator grant for the continued development and commercialization of pHyph, an antibiotic free treatment for vaginal infections. The funding will accelerate the development of pHyph, bringing this treatment earlier to patients in need.

• EIC Accelerator is the most competitive program of its kind in Europe – for the November 2023 cutoff only 42 out of 1083 (~4%) applicants were selected for funding.
• The final decision was taken by a highly experienced jury who verified the uniqueness and commercial potential of pHyph.

 

Gedea applied for the EIC grant to accelerate the development of Gedea’s lead product pHyph via clinical validation and regulatory approval process – together with initial go-to-market steps. The formal EU Grant Agreement preparation process has already been initiated.

pHyph is a global breakthrough antibiotic-free treatment for both bacterial and fungal vaginal infections that affect >400 million women every year. Current treatments have numerous side effects, high risk of recurrence and can lead to development of antimicrobial resistance. pHyph has shown a clinical cure rate for bacterial vaginosis in line with antibiotics on the market, with a superior safety profile and without causing secondary VVC infections, a common side effect of antibiotics. The results for fungal vaginal infections are promising.

“Being selected in this highly competitive EIC Accelerator process is yet another proof of the importance of supporting women’s health and a quality stamp of our work in developing antibiotic-free treatment options for common female infections”, says Annette Säfholm, CEO of Gedea Biotech. The funding will strengthen Gedea and allow us to support our “go-to-market" efforts in all aspects of pHyph development.” says Annette Säfholm.

“Today, I am extremely proud of the team, the support from our investors and of our achievements and I am particularly grateful that the EIC has recognized Gedea’s ability to support the development of an antibiotic-free treatment option  ̵  thereby fighting overall antimicrobial resistance (AMR).” says Ton Berkien, Chairman of the Board.

 ·      The study aims to confirm the safety and efficacy of pHyph in the treatment of vaginal yeast infection (VVC).

·      The study includes 26 patients, all of whom have now commenced treatment with pHyph.

·      Results from the study are expected in the second quarter of 2024.

Lund, Sweden, February 8, 2024

The Swedish femtech company Gedea Biotech, which is developing an antibiotic-free treatment for vaginal infections, today announced that all patients in the EpHect study have been included and commenced treatment with pHyph. Results from the study are expected in the second quarter of this year.

Vaginal yeast infection affects 75% of all women at some point in their lives. Treatment is usually an over-the-counter cream or suppositories, and if symptoms are severe or recurrent, prescription per oral treatment is available. Globally, there are signs of and concerns about resistance developing against available treatments. Self-diagnose is difficult and studies show that a majority of women who purchase over-the-counter products for the treatment of vaginal yeast infection do not actually have a yeast infection. This leads to over-treatment and the risk of resistance developing.

The EpHect study has been conducted at four clinics in Sweden, with a total of 26 patients participating. Patients have been treated with pHyph for six days using vaginal tablets at home. After the treatment period, patients were followed up for 25 days to evaluate treatment effectiveness and whether the infection recurs. The clinics have used internationally applicable criteria for diagnosis and evaluation.

"Vaginal fungal infection is very common, and some women suffer from prolonged, recurrent symptoms. The drugs available usually work well, but relapses are common, and there is concern about resistance developing in the future. More treatment options are needed for this patient group," says Helena Kopp-Kallner, Chief Physician in Gynecology, Ph.D., at the Women's Health Clinic at Danderyd Hospital, Stockholm, Sweden, who is the responsible physician for the EpHect study.

Annette Säfholm, CEO of Gedea Biotech, comments:

"The clinics that have participated in the study have done a fantastic job of including patients and conducting the study. We are also extremely grateful to the patients who have participated and contributed to important research. The purpose of the EpHect study is to confirm the safety and efficacy of pHyph in the treatment of vaginal yeast infection. A product with dual effect in the treatment of bacterial vaginosis and yeast infections would be an ideal treatment for all the women who are unsure of the type of infection causing their symptoms."

The EpHect study is supported by Swelife and MedTech 4 Health. 

 

For more information

For further information, please contact:

Annette Säfholm, CEO Gedea Biotech

Phone: +46 708 - 91 86 81

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

 

Ton Berkien, Chairman of the Board, Gedea Biotech

Phone: +46 70- 791 49 54

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

 

About the EpHect study

An open-labelled study to evaluate Clinical Performance of the Gedea Pessary (pHyph) in Adult Women with Vulvovaginal Candidiasis:

26 women of menstruating age over 18 years with a VVC diagnosis are treated for 6 days (day 0 to day 5) and undergo follow-up visits until day 25. More information about the study can be found here: https://clinicaltrials.gov/ct2/show/NCT05507333?spons=Gedea+Biotech&draw=2&rank=1

About pHyph

pHyph is being developed as a vaginal tablet to treat and prevent both vaginal yeast infection and bacterial vaginosis. pHyph has no antimicrobial properties but affects the vaginal environment by lowering pH and dissolving biofilm so that the presence of yeast and bacteria develops in a healthy manner. With the dual effect against both yeast and bacterial infection, the chance of correct self-care increases, leading to reduced use of antimicrobial products and thus reduced resistance development. The naturally occurring active ingredient GDA 001 in pHyph is well-documented and is already approved as a food additive. A clinical healing rate for BV comparable to antibiotics on the market has been shown in two phase 2 studies but with a higher safety profile and without causing secondary VVC infections that occur with antibiotics.

 

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   

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.

 

Gedea Biotech raises 1.5 MEUR (16.5 MSEK) in oversubscribed rights issue as registration CL3-2 trial begins 

Lund, Sweden, November 15, 2023: Gedea Biotech today announced that it has raised 1.5 MEUR (16,5 MSEK) to initiate and accelerate clinical trial activities supporting pHyph™ applicable for antibiotic free treatment of vaginal infections. The funds will be used to: 

• Initiate patient recruitment in the recently approved registration CL3-2-study. 
• Reach upcoming data readout from the CL4 -study to obtain pHyph proof-of-concept for treating vaginal fungal infections.  
• Perform microbiome analysis from the CL3-study. 
  Read more ...

• This pivotal study aims to confirm the safety and efficacy of pHyph in treating and preventing BV recurrence
• Patient recruitment will now be initiated and 5 Swedish clinics are planned to attend
• Previous studies in BV have demonstrated pHyph to have a BV cure rate in line with antibiotics on the market, with superior safety profile and without causing the secondary candida infections and the high recurrence seen when treating BV with antibiotics

• Further strengthens Gedea Biotech’s broad patent portfolio
• pHyph has demonstrated a superior safety profile, a cure rate in line with antibiotics and a lower infection recurrence rate
• Additionally, unlike antibiotics, pHyph will not promote antimicrobial resistance    

Lund, Sweden, September 13, 2023. Swedish women’s health company Gedea Biotech announced today that the European Patent Office (EPO) has granted the company´s patent application no. 20715885.8 for the formulation of the active ingredient, Glucone-delta lactone (GDL) in pHyph™, the company’s vaginal tablet for treatment of vaginal infections. The patent number is 3976000 and the patent runs until 2040. Glucono-delta lactone (GDL) in pHyph™ is a well-documented substance with a low risk for contributing to antimicrobial resistance.

 

Gedea Biotech has developed the world’s first antibiotic-free treatment to both treat and prevent bacterial vaginosis. The treatment is called pHyph, and is a vaginal tablet that has shown a medical effectiveness in treating bacterial vaginosis in line with antibiotics on the market, but with a superior safety profile and lower risk of recurrence.

Read the entire article published in Näringsliv Life Science, here.

Lund, Sweden, May 24, 2023: Gedea Biotech today announced that it has raised 1.3 MEuros (14 MSEK) for additional development activities of their product pHyph for antibiotic free treatment of vaginal infections. The funds will be used for:

• An ongoing proof-of-concept study for the treatment of Vulvo Vaginal Candidiasis (VVC) with pHyph, partially financed by a recent grant from Swelife and Medtech4Health
• Investigating how the vaginal microbiome changes during short- and long-term treatment with pHyph in patients with bacterial vaginosis
• Preparation of an additional clinical study for the treatment of bacterial vaginosis, planned to start after the summer.

Current as well as new shareholders from Family Offices and Business Angels with a track record as life science investors participated in the funding round.

 

• Up to 75% of all women are affected by vaginal infection in their lifes
• Self-diagnoses leads often to unnecessary and inappropriate treatment use
• This study aims to confirm the safety and efficacy of pHyph in VVC

Lund, Sweden, May 2, 2023. Gedea Biotech today announces that the treatment of the first patients with its lead product, pHyph, a vaginal tablet for topical treatment, has begun. The open-labelled study is designed to confirm the safety and efficacy of pHyph in treating adult women with confirmed Vulvo Vaginal Candidiasis (VVC) and in restoring a beneficial vaginal microbiome to prevent recurrence of the infection. The study is being conducted at four Swedish gynecological clinics.

• Important expansion of patent estate in the largest market for vaginal bacterial infections
• pHyph has shown superior safety profile, a cure rate in line with antibiotics and a lower infection recurrence rate

Lund, Sweden April 12, 2023: Gedea Biotech announces today that Anna-Karin Areskog has been appointed QA Director and that their ISO13485* re-certification has been approved. Both the announcement and the approved certification are important milestones for achieving CE marking for pHyph, the company’s antibiotic-free treatment for bacterial vaginosis.

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). 

News

The results from the NEFERTITI-study have received much attention since they were first published in a press release from October 11th. During the last week of November, there were no less than three publications that mentioned Gedea and were spread through e.g., Twitter and LinkedIn.

First out was Biose with an article about the drug landscape targeting health issues within the women’s health area, covering Bacterial Vaginosis, Vulvovaginal Candidiasis, Urinary tract infections and HIV, and also included a summary of facts on the vaginal microbiome. Among the companies mentioned besides Gedea was Ferring, Rebiotix and MyBiotics’ collaboration project on live microbiota formulations to address BV.

Citation: “Gedea Biotech aims to develop “the first antibiotic-free treatment” for BV prevention. Citing the growing public health threat of antibiotic resistance as a driver, Gedea’s BV candidate, pHyph, hopes to address an unmet medical need. Founded in 2015, Gedea have conducted multiple studies to validate their product and will be embarking on a study into VVC soon.”

• https://www.biose.com/2022/11/23/targeting-the-vaginal-microbiome-to-develop-novel-therapeutics/

Uppdated 2022-11-14

- Symptom reduction was seen in 90% of patients and absence of symptoms was noted in 70% of patients
- Clinical cure rate was 50,4% in the pHyph group, which is in line with many antibiotic treatments on the market
- The rate of recurrence of BV was substantially lower at day 35 with pHyph, 13.9%, compared to placebo, 27%, and throughout the 4 months¹

Lund, Sweden, October 11th, 2022. Gedea Biotech, an innovative women’s health company today reported top-line results from a clinical study, NEFERTITI, of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). NEFERTITI is a placebo-controlled, double blind clinical trial performed in Sweden and UK in 150 patients. The treatment is a vaginal tablet taken once daily for 6 days at home. Already on the first day after pHyph treatment, a pronounced reduction of fishy smell, which is the most disturbing symptom of BV was observed, and after treatment, 70% of patients were completely free of the symptom and 90% of patients experienced alleviation. pHyph treatment resulted in 50.4% cure rate after 6 days, (n=115).

 

PRESS RELEASE

Gedea Biotech today announces that it has received regulatory approval from the Ethics Committee and the Swedish Medical Products Agency and will start the EpHect clinical study of its lead product, pHyph, a vaginal tablet for topical treatment. The open-labelled study is designed to confirm the safety and efficacy of pHyph in treating adult women with confirmed Vulvo Vaginal Candidiasis (VVC) and in restoring a beneficial vaginal microbiome to prevent recurrence of the infection. The study will be conducted at four Swedish clinics and at a clinic in United Kingdom.