- 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,
Miconazole-Domiphen Bromide is being developed in partnership with
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
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
About
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,
For more information, please contact:
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;
2 D.W Denning et al.. Lancet Infectious Diseases (2018); D Rosati D et al., An Immunological Perspective, Microorganisms (2020)
3
4 J Tits., J et al., Antimicrob. Agents Chemother (2020);
5 Manuscript for scientific paper submitted
Attachment
- 211102 Hyloris Press Release Phase 2 Start MCZ-DB_ENG
Source:
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