Hyloris Announces Start of Phase 2 Study of Miconazole-Domiphen Bromide Vaginal Cream in Vulvovaginal Candidiasis
02 Novembre 2021 - 07:00AM
Hyloris Announces Start of Phase 2 Study of Miconazole-Domiphen
Bromide Vaginal Cream in Vulvovaginal Candidiasis
- 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 studyThe
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-DBVVC 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
Mediainvestorrelations@hyloris.com Disclaimer and
forward-looking statementsHyloris 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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