Per-Ola Forsberg new CFO at Gedea

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.

Gedea Biotech selected for prestigious grant funding from the European Innovation Council, EIC

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 Swedish femtech company Gedea Biotech completes important clinical trial on vaginal fungal infection

 ·      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

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. 

Gedea Biotech receives approval to initiate the pivotal NEFERTITI-2 clinical study documenting the performance of pHyph for treatment of bacterial vaginosis

  • 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

Gedea Biotech granted European Patent for the formulation of its vaginal pHyph tablet for women with vaginal infections

  • 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.

 

Making a difference to women worldwide

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.

Gedea Biotech secures 1.3 MEuros (14 MSEK) to advance its antibiotic-free vaginal infection treatment pHyph towards market launch

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.

Gedea Biotech initiates EpHect Clinical Trial for Antibiotic-free Treatment of Women with Vulvo Vaginal Candidiasis

 

  • 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.

Gedea Biotech obtains US-patent covering pHyph for antibiotic-free treatment and prevention of bacterial vaginosis

  • 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

Gedea Biotech appoints Anna-Karin Areskog as QA Director and receives ISO13485 certification

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.

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). 

Two mentions and one article in three publications during end of November

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/

Gedea Biotech reports results from placebo-controlled clinical trial of pHyph, an antibiotic-free treatment for bacterial vaginosis

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).

Gedea Biotech to Start EpHect Clinical Trial for Antibiotic-free Treatment of Women with Vulvo Vaginal Candidiasis

 

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.

Gedea Biotech wins the "Rapidus company of the year" award

PRESS RELEASEArets Rapidusforetag

Gedea Biotech has been awarded the prestigious award "Rapidus Company of the Year". The ceremony was held at Rapidus annual "birthday party", Thursday April 28th. This title has been awarded annually since 2001 and companies such as Cellavision, FlatFrog, QlikTech and Camurus have all been awarded. Rapidus awards companies that are the “Big Industries” of the future, i.e. small companies with potential, according to their harsh criteria.

Read  more: https://rapidus.se/referat-en-fodelsedag-i-venus-tecken/

Gedea Biotech has completed the recruitment for NEFERTITI clinical trial of pHyph antibiotic-free treatment of bacterial vaginosis

PRESS RELEASE

Lund, Sweden, February 08, 2022. Swedish women’s health company Gedea Biotech today announced that despite the COVID-19 pandemic it has successfully completed recruitment 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 across 6 UK and 4 Swedish sites. Results from the first treatment period (day 0-7) are expected in Q2 and for the follow-up period in Q3. This would put the company in a strong position to achieve CE-marking by the end of the year. 

Gedea Biotech - Top 20 European Biotech Companies to Watch in 2022

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 20 European Biotech Companies to Watch in 2022". 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 receives funding for microbiome research project with Centre for Translational Microbiome Research at Karolinska Institutet

PRESS RELEASE 

Lund, Sweden, December 21, 2021. Swedish women’s health company Gedea Biotech today announced that it has received funding for a research project with the Centre for Translational Microbiome Research at Karolinska Institutet (KI), for its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The project goal is to 
better understand the microbial etiology of bacterial vaginosis (BV) and factors associated with successful, antibiotic-free treatment with pHyph.

New Chairman of the board

Ton Berkien 2021 mediumLund December 1, 2021. Femtech start-up Biotech today announces that Ton Berkien has been elected Chairman of the Board of Directors of Gedea Biotech. He replaces Olov Sterner, one of the founders of Gedea who continues as a board member.
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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