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We are of course delighted to complete an oversubscribed funding round in the current climate, and I would like to thank our investors both new and old for their tremendous support. It comes just as we have received approval to initiate our registration CL3-2 study, which is vital for receiving European approval for pHyph in treating and preventing bacterial vaginosis recurrence. It also allows us to support the preparations for pivotal phase 3 studies for FDA drug approval.
Annette Säfholm, Gedea Biotech’s CEO
The oversubscription has the additional benefit of enabling us to extend the runway for the CL3-2 study and thus prepare us for the next funding stage which could lead us through pHyph approval. 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.
Chairman of the board Ton Berkien
Bacterial vaginosis is a very common vaginal infection caused by an overgrowth of unhealthy bacteria in the vagina and affecting 1-2 in every 10 women. While standard antibiotic treatments work well in the short term, there is a very high rate of recurrence and as antibiotic resistance grow, we should avoid prescribing antibiotics if there are alternatives. There is therefore a need for an effective antibiotic-free product which can treat BV and prevent recurrence.
Coordinating Investigator Aino Fianu Jonasson, MD, PhD and specialist in Urogynecology at the Womens Health Department, Karolinska University Hospital, Huddinge, Sweden.
In previous studies, pHyph has shown a good effect in treating BV in line with antibiotics on the market, but with superior safety profile and without causing the secondary candida infections and the high recurrence seen when treating BV with antibiotics. This pivotal study constitutes a vital component to receive European approval for pHyph™ in treating and preventing bacterial vaginosis recurrence as well as to prepare for pivotal phase 3 US studies.
Annette Säfholm, Gedea Biotech’s CEO
The new patent strengthens Gedea’s patent protection in Europe, expected to be the first market for launch, and with granted patents for treatment of vaginal fungal infections in all major markets and for treatment of and protection against bacterial vaginosis in USA, we are approaching a very strong patent protection position. We are also planning additional clinical studies to support our up-coming application for CE-marking in Europe.
Annette Säfholm, Gedea Biotech’s CEO
We are delighted to have succeeded in raising more funds for our additional clinical documentation of pHyph and also to investigate its wider impact on the vaginal microbiome. We particularly welcome the engagement by the new shareholders. The commitment from new, experienced life science investors to support our journey validates the trust in our company and our plans for the further development of pHyph.
Annette Säfholm, CEO of Gedea Biotech
In the current, rather harsh climate for investments, it is quite an achievement to raise funds within life sciences, and I would like to express my thanks to both current and new investors and welcome them warmly to be part of the exciting Gedea journey.
Chairman of the board Ton Berkien
In previous studies, pHyph has shown a good effect in treating BV in line with antibiotics on the market, but with superior safety profile and without causing the secondary candida infections and the high recurrence seen when treating BV with antibiotics. pHyph has furthermore in previous clinical studies been shown to restore the beneficial vaginal microbiome, important also for treating and preventing vaginal candida infections. The aim of this study is to confirm the safety and efficacy of pHyph in treating VVC. A product with dual effect in treating bacterial vaginosis and vaginal candidiasis would be an ideal treatment for the large group of women who are uncertain of which type of infection that causes their symptoms.
Annette Säfholm, CEO of Gedea Biotech
Vaginal Candida infection, or vaginal yeast infection, is a common concern for women. A fungal infection can, for example, be caused by antibiotic treatment for urinary tract infections or throat infections. An antibiotic treatment also kills the protective bacteria that counteract other infections and fungi and allows the fungus to establish itself. Today, fungi are treated with so-called antifungal drugs that can lead to the development of resistance. Since the fungal problem often returns, women often need repeated treatments. Hence, there is therefore a need for an effective product which can prevent the problem with returning fungal infections or a product void of antifungals which can be applied several times such as Gedea's product.
Helena Kopp Kallner, chief physician at Danderyd Hospital Clinical Sciences Obstetrics and Gynecology and principal investigator in the study.
The US patent covering treatment and prevention of vaginal bacterial infections by GDL, or pHyph, strengthens Gedea’s position in one of the largest markets for treatment of these conditions. pHyph has the potential to replace a substantial share of the antimicrobials used for vaginal infections today.
Annette Säfholm, CEO Gedea Biotech
I am passionate about contributing to small innovative companies like Gedea with my experience. Realizing the large unmet need for Gedea’s product pHyph for relieving symptoms and preventing recurrence of bacterial vaginosis, I am so proud to be part of the development work.
Anna-Karin Areskog, QA Director, Gedea Biotech
We are delighted to receive this grant from SWElife and MedTech4Health, an investment that is particularly welcome given that women's health is a neglected area. The study, which aims to confirm the safety and efficacy of pHyph in the treatment of vulvovaginal candidiasis (VVC), also focuses on analyzing how the vaginal microbiome - believed to play a key role in preventing recurrence - is affected by the treatment.
Annette Säfholm, CEO of Gedea Biotech.
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