News - Gedea Biotech

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

05 December 2022

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

11 October 2022

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

18 May 2022

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

02 May 2022

PRESS RELEASE

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

08 February 2022

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

07 February 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

21 December 2021

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

01 December 2021

Lund 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.

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

25 October 2021

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

24 September 2021

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

03 September 2021

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

14 June 2021

Now, 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

03 February 2021

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

14 January 2021

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

18 December 2020

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

30 November 2020

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

07 April 2020

Lund, 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

11 March 2020

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

06 March 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

10 January 2020

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:

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.

%MCEPASTEBIN%