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Gedea Biotech

gedeabiotech.com

Founded Year

2015

Stage

Grant | Alive

Total Raised

$290K

Last Raised

$50K | 4 yrs ago

About Gedea Biotech

Gedea Biotech is developing a new treatment method for vaginal infections.

Headquarters Location

Scheelevägen 2

Lund, 223 63,

Sweden

+46 (0) 708 - 91 86 81

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Expert Collections containing Gedea Biotech

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Gedea Biotech is included in 2 Expert Collections, including Women's Health & Wellness.

W

Women's Health & Wellness

1,482 items

Startups focused on providing products and services catering to women's health and wellbeing.

B

Biopharma Tech

15,535 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

Gedea Biotech Patents

Gedea Biotech has filed 1 patent.

The 3 most popular patent topics include:

  • Animal fungal diseases
  • Bacteriology
  • Microbiology
patents chart

Application Date

Grant Date

Title

Related Topics

Status

4/6/2017

5/4/2021

Dosage forms, Drug delivery devices, Animal fungal diseases, Glucocorticoids, Vagina

Grant

Application Date

4/6/2017

Grant Date

5/4/2021

Title

Related Topics

Dosage forms, Drug delivery devices, Animal fungal diseases, Glucocorticoids, Vagina

Status

Grant

Latest Gedea Biotech News

Gedea Biotech reports results from bacterial vaginosis trial

Oct 11, 2022

Photo/Shutterstock Gedea Biotech has 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. Treatment details The treatment is a vaginal tablet taken once daily for six 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 a 50.4% cure rate after six days. The placebo treatment reduced BV symptoms, although later and to a lower degree than pHyph. The cure rate for the placebo treatment was 46.6% (n=30) and it was impacted by an unexpected effect of the placebo (tablet) filling material in promoting the growth of lactobacilli, subsequently causing a pH reduction, and relieving the BV symptoms, a finding that led to a new patent filing. Also, pHyph treatment showed a considerably lower recurrence rate compared to placebo, though not statistically significant, both at day 35 (pHyph: 13.9%, placebo: 27% and among patients having taken Metronidazole (antibiotics) as rescue treatment: 47.5%) and throughout the four-month study period. Further analysis on occurrence of vaginal dysbiosis is planned as well as a scientific article on the full analysis results. No patient on pHyph treatment experienced secondary vulvovaginal candidiasis infections during the follow-up period while one patient was diagnosed in the placebo group and at least three patients among those given rescue antibiotic treatment, even though adverse event reporting wasn’t required for this group. There were no serious adverse events observed among patients receiving pHyph treatment, and no safety concerns. Content continues below Related Content Based on these results the company now continues the process for European CE mark approval of pHyph and further on, plans to initiate phase 3 trials for subsequent FDA approval in the U.S. About bacterial vaginosis 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 including a vaginal discharge, a fishy odor and sometimes a burning pain. The condition is treated with antibiotics and/or antiseptic treatment products but recurring bacterial vaginosis is common and treatment with antibiotics often induce vulvovaginal candidiasis. Approximately 8 million prescriptions of antibiotics are currently issued each year for BV in the U.S. and in the EU combined. Antibiotic resistance “We do have standard antibiotic treatments for bacterial vaginosis, which usually work quite well in the short term, but there is a very high rate of recurrence. Women often have to take multiple courses of antibiotics to keep symptoms away. This of course contributes to the global problem of antibiotic resistance,” said Helena Strevens, senior consultant, associate professor, Dept of Obstetrics and Gynecology, Skåne University Hospital. “A non-antibiotic treatment preventing recurrence would be a major step forward. The fact that pHyph relieves symptoms almost immediately is very appreciated among patients.” Several advantages Annette Säfholm, Gedea Biotech’s CEO, said:  “We are happy to finally report the results from the NEFERTITI study and to take the next important step towards making pHyph available for women in the world. The NEFERTITI trial was conducted during the challenging times of Covid-19 and I´m impressed by the dedicated work of the investigators and their teams in managing to complete the study. Content continues below Related Content “The data confirms that treatment with pHyph has several advantages compared to current treatment options; the rapid and high degree of symptom reduction, lower recurrence rates and that it does not induce secondary fungal infection. We strongly believe that pHyph will replace antibiotics as the first in line treatment for bacterial vaginosis for many patients. “The finding that the cure rate in the placebo group was higher than ever previously observed in a published placebo-controlled BV-trial was intriguing and led us to some interesting results. Consequently, we have filed a new patent application for the use of active substance contained in the placebo.”  Further analysis of the data will follow including analysis of the vaginal microbiome (in cooperation with Karolinska Institutet) regarding presence of Candida and the effect on lactobacilli and pathogenic bacteria. Explore Related Topics:

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Gedea Biotech Frequently Asked Questions (FAQ)

  • When was Gedea Biotech founded?

    Gedea Biotech was founded in 2015.

  • Where is Gedea Biotech's headquarters?

    Gedea Biotech's headquarters is located at Scheelevägen 2, Lund.

  • What is Gedea Biotech's latest funding round?

    Gedea Biotech's latest funding round is Grant.

  • How much did Gedea Biotech raise?

    Gedea Biotech raised a total of $290K.

  • Who are the investors of Gedea Biotech?

    Investors of Gedea Biotech include Horizon 2020, Almi Invest and Port-Monnaie Venture.

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