Hyloris announces the start of the Phase 2 study. known

  • Miconazole Domiphenbromide (MCZ-DB) vaginal cream is a candidate product for the treatment of recurrent vulvovaginal candidiasis (rVVC), which affects 10% of all women worldwide
  • Topline results expected in H2 2022

Liege, Belgium – November 2 2021 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialist biopharmaceutical company committed to meeting unmet medical needs by reinventing existing drugs, today announced that the first patient has been enrolled in the phase 2 dose-finding study of miconazole domiphen bromide (MCZ-DB), a novel dual-mode vaginal cream for the treatment of recurrent vulvovaginal candidiasis (rVCC) that is being developed in collaboration with Purna Female Health. Recurrent VVC is also known as chronic yeast infection and is defined as four or more symptomatic acute episodes of yeast infection per year.

Hyloris Chief Executive Officer, Stijn Van Rompay, commented: We are happy that the first object Has was dosed in the phase 2 study of our novel, dual mode of action Candidate product, which connects Miconazole Nitrate 2% cream, a currently available vaginal cream used to treat acute VVC, with domiphen bromide, a medicinal ingredient with antiseptic properties. MCZ-DB is a locally applied vaginal cream, and based on promising results from preclinical Studies, we believe it could have been considerable potential in recurrent VVC infections, an underserved condition for which There is none locally managed currently Therapies for now available. We look forward to reporting on the topline results that came out during the second half by 2022.

Miconazole domiphen bromide is being developed in collaboration 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 upon signature) and will lead the commercialization and out-licensing activities. The European patent entitled “Compositions against Candida Infection” was granted in July 2021.

About the phase 2 study
The phase 2 study is a multicenter, randomized, double-blind, active-controlled study (3 study arms) in which up to 90 female volunteers with confirmed acute VVC between the ages of 18 and 50 are expected to participate. The primary goals on Day 15 include the efficacy and safety of two different doses of MCZ Nitrate 2% + DB (MCZ-DB) given once daily for 7 days compared to MCZ Nitrate 2% (Gyno-Daktarin ®) alone. In addition, the study aims to determine the optimal DB dose after 7 days of treatment for VVC by assessing its effectiveness and safety during the 12 weeks of follow-up from the start of treatment. The secondary goals include the effectiveness of MCZ-DB versus MCZ-Nitrate 2% alone in treating VVC based on the rate of cure for VVC on Day 29, Day 57 and Day 85, and on patient-reported results through Week 12. The exploratory goals include the pharmacokinetics (PK) of MCZ-DB on day 7 before and after administration; the effectiveness of MCZ-DB compared to MCZ-nitrate 2% alone in recurrence of VVC by week 12; and quality of life ratings. The study will be carried out in at least 4 study centers, all of which are located in Belgium.

Above severe and recurring VVC and MCZ-DB
VVC is a vaginal fungal infection commonly caused by the yeast Candida albicans that affects up to one in two women with approximately 175 million units sold worldwide during their lifetime.1 Up to 20% of VVC patients develop severe to recurrent VVC, with reinfection occurring more than four times a year. These are long-term conditions that cause significant pain and suffering, with an estimated economic burden from lost productivity of up to $ 14.39 billion annually through 2030.2 There is a great unmet need for new treatment options for severe and rVVC because current standard treatments have significant drawbacks, including lack of efficacy, development of drug resistance due to continued use, and liver toxicity.3 Preclinical studies have shown that the activity of miconazole (MCZ), the current topical standard of care, in combination with the miconazole potentiator domiphenbromide can combat the occurrence and recurrence of vaginal candida infections associated with mucosal biofilms.4th MCZ and DB act synergistically, with DB increasing the permeability of the plasma membrane and the vacuole membrane of Candida spp. and MCZ has a fungicidal effect, which effectively destroys fungal activity and prevents further fungal growth. The synergistic mechanism of action of topical MCZ-DB has the potential to be effective against azole-resistant infections and potentially to meet the high unmet need for recurrent VVC.5

About Hyloris Pharmaceuticals
Hyloris is a specialist biopharmaceutical company focused on innovating, reinventing and optimizing existing drugs to meet critical health needs and achieve relevant improvements for patients, healthcare professionals and payers. Hyloris has built a broad, patented portfolio of 13 reformulated and reused value-added drugs that have the potential to offer significant advantages over available alternatives. Outside of its strategic core focus, the company also has 3 generics with high accessibility in the development and registration phase. Two products are currently in the early stages of commercialization with partners: Sotalol IV for the treatment of atrial fibrillation and Maxigesic® IV, a non-opioid post-operative pain reliever. The company’s development strategy is primarily focused on the FDA’s 505 (b) 2 regulatory pathway, which is specifically designed for drugs for which the safety and efficacy of the molecule have already been demonstrated. This approach can reduce the clinical effort required to bring a product to market and significantly shorten development times as well as reduce costs and risks. Hyloris is based in Liege, Belgium. For more information, please visit www.hyloris.com and follow us on LinkedIn.

For more information, please contact:
Hyloris Pharmaceuticals, Investor Relations and Media
[email protected]

Disclaimer and Forward-Looking Statements
Hyloris means “high return, lower risk” which refers to the 505 (b) (2) regulatory pathway for product approval which the Issuer focuses on but in no way affects or relates to any investment in the Shares.
Certain statements in this press release are “forward-looking statements”. These forward-looking statements may be identified using forward-looking terminology, including the words “believes,” “estimates,” “expects,” “expects,” “intends,” “may,” “will,” “plans,” “continues,” ” ongoing includes “,” potentially, “predict,” “project,” “aim,” “seek,” or “should” and statements by the company about the intended results of its strategy, such as statements about future events or future financial performance of the company and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the company and which could lead to the actual results, activities, performance, or achievements of the company or its industry differs materially from those in Any forward-looking statements expressed or implied Say publicly to update or revise unless required by law.

1 FIOR markets 2019; Global information research; IMS

2 DW Denning et al.. Lancet Infectious Diseases (2018); D Rosati D et al., An Immunological Perspective, Microorganisms (2020)
3 PG pappas et al., Clinical Infectious Diseases (2016); JD Sobel et al., Expert opinion on pharmacotherapy (2018)
4th J boobs., J et al., Antimicrobial. Agent Chemother (2020); K. De Cremer et al., Antimicrobial Agents and Chemotherapy (2015)
5 Manuscript submitted for academic paper

  • 211102 Hyloris press release phase 2 start MCZ-DB_GER

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