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Hyloris Announces Start of Phase 2 Study of Miconazole-Domiphen Bromide Vaginal Cream in Vulvovaginal Candidiasis

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  • Miconazole-Domiphen Bromide (MCZ-DB) vaginal cream is a candidate product for the treatment of recurring vulvovaginal candidiasis (rVVC), which affects 10% of all women globally

  • Topline results anticipated in H2 2022

Liège, Belgium – 2 November 2021 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that the first patient has been enrolled in the Phase 2 dose-finding study of Miconazole-Domiphen Bromide (MCZ-DB), a novel dual-mode-of-action vaginal cream for the treatment of recurring vulvovaginal candidiasis (rVCC) that is being developed in partnership with Purna Female Health. Recurring VVC is also known as chronic yeast infection and is defined as four or more symptomatic acute episodes of yeast infection per year.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: We are pleased that the first subject has been dosed in the Phase 2 study of our novel, dual mode-of-action candidate product, which combines miconazole nitrate 2% cream, a currently available vaginal cream used to treat acute VVC, with domiphen bromide, a medicinal ingredient with anti-septic properties. MCZ-DB is a locally applied vaginal cream, and based on promising results from preclinical studies, we believe that it could have significant potential in recurring VVC infections, an underserved condition for which there are no locally administered topical therapies currently available. We look forward to reporting the topline results, which are anticipated during the second half of 2022.

Miconazole-Domiphen Bromide is being developed in partnership with Purna Female Health (PFH). Under the terms of the agreement announced in February 2021, Hyloris has committed to milestone related investments of up to €4.3 million in PFH (of which €1.27 million paid at signing) and will lead the commercialisation and out-licensing activities. The European patent entitled “Compositions against Candida Infections” was granted in July 2021.

About the Phase 2 study
The Phase 2 study is a multi-centre, randomised, double-blind, active-controlled study (3 study arms), which is expected to enrol up to 90 female subjects with confirmed acute VVC, aged 18-50 years. The primary objectives at Day 15 include the efficacy and safety of two different doses of MCZ nitrate 2% + DB (MCZ-DB), administered once per day for 7 days, as compared to MCZ nitrate 2% (Gyno-Daktarin®) alone. In addition, the study aims to determine the most optimal dose of DB after 7-day treatment of VVC, by assessing efficacy and safety during 12 weeks of follow-up from start of treatment. The secondary objectives include the efficacy of MCZ-DB compared to MCZ nitrate 2% alone in the treatment of VVC based on the cure rate of VVC at Day 29, Day 57, and Day 85, as well as on patient-reported outcomes through Week 12. The exploratory objectives include pharmacokinetics (PK) of MCZ-DB at Day 7 before and after administration; the efficacy of MCZ-DB compared to MCZ nitrate 2% alone on the recurrence of VVC through Week 12; and quality of life evaluations. The study will be conducted in at least 4 study sites, all located in Belgium.

About severe and recurring VVC and MCZ-DB
VVC is a vaginal fungal infection commonly caused by the yeast Candida albicans, affecting as many as one in every two women during their life, with about 175 million units sold per year globally.1 Up to 20% of VVC patients develop severe to recurrent VVC where reinfection occurs more than four times per year. These are long-term conditions that cause significant pain and distress, with an estimated economic burden from lost productivity of up to $14.39 billion annually by 2030.2 There is a high unmet need for novel treatment options in severe and rVVC as current standard of care treatments have significant drawbacks, including lack of efficacy, the development of drug resistance due to continued use and liver toxicity.3 Preclinical studies have demonstrated that the activity of Miconazole (MCZ), the current topical standard of care, when combined with the Miconazole potentiator Domiphen Bromide, can combat the occurrence and recurrence of mucosal biofilm-related vaginal Candida infections.4 MCZ and DB work synergistically where DB increases the permeability of the plasma membrane and the vacuolar membrane of Candida spp., and MCZ acting fungicidal, thereby effectively destroying fungal activity and preventing further fungal growth. The synergistic mode-of-action of topical MCZ-DB has the potential to be effective against azole-resistant infections, possibly addressing the high unmet needs in recurring VVC.5

About Hyloris Pharmaceuticals
Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimising existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 13 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Outside of its core strategic focus, the Company also has 3 high barrier generic products in development and registration phase. Two products are currently in initial phases of commercialisation with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.

For more information, please contact:
Hyloris Pharmaceuticals, Investor Relations and Media
investorrelations@hyloris.com



Disclaimer and forward-looking statements
Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Issuer focuses, but in no way relates or applies to an investment in the Shares.
Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

1 FIOR Markets 2019; Global Info Research; IMS

2 D.W Denning et al.. Lancet Infectious Diseases (2018); D Rosati D et al., An Immunological Perspective, Microorganisms (2020)
3 P.G. Pappas et al., Clinical Infectious Diseases (2016); J.D. Sobel et al., Expert Opinion on Pharmacotherapy (2018)
4 J Tits., J et al., Antimicrob. Agents Chemother (2020); K. De Cremer et al., Antimicrobial agents and chemotherapy (2015)
5 Manuscript for scientific paper submitted

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