Hyloris and Purna Female Healthcare Announce Positive Results from Phase 2 Trial in Patients with Acute Vulvovaginal Candidiasis (VVC)
January 30 2024 - 1:00AM
UK Regulatory
Hyloris and Purna Female Healthcare Announce Positive Results from
Phase 2 Trial in Patients with Acute Vulvovaginal Candidiasis (VVC)
Hyloris and Purna Female Healthcare
Announce Positive Results from Phase 2 Trial in Patients with Acute
Vulvovaginal Candidiasis (VVC)
- Both
treatment arms with the combination of Miconazole (2%) and Domiphen
Bromide (0.14% or 0.29%) demonstrated excellent safety and
tolerability
- Low dose
(0.14%) showed significant improvement over active control in
clinical and mycological outcome at day 291
Liège, Belgium – 30 January 2024, 07:00
AM CET – Regulated information – Inside information – Hyloris
Pharmaceuticals SA (Euronext Brussels: HYL), a specialty
biopharma company committed to addressing unmet medical needs
through reinventing existing medications, today announces positive
results for the phase 2 trial of Miconazole Domiphen-Bromide
(MCZ-DB) in patients with acute vulvovaginal candidiasis.
The phase 2 trial of MCZ-DB was a 12-week,
randomized, double-blind, active-controlled, dose finding trial
evaluating the safety and efficacy of two doses of MCZ-DB (MCZ 2%
combined with 0.14% or 0.29% of DB) administered once per day for 7
days in patients with acute vulvovaginal candidiasis. The study has
been conducted in Belgium with a total of 102 patients enrolled.
Efficacy was evaluated by assessing the clinical outcome and
mycological outcome to the treatment. A positive clinical outcome
is a resolution of VVC signs and symptoms whereas the mycological
outcome is determined by a vaginal swab indicating the absence of
Candida species yeast.
Top line results are summarized:
- At day
291, day 57 and day 85, the low dose (MCZ and 0.14% of
DB) demonstrated superior efficacy compared to the active control
(MCZ).
- At day 15, both doses administered
demonstrated positive safety and tolerability without significant
superiority over the active control.
- MCZ-DB was well tolerated in both
dose cohorts, with no reported serious adverse events.
- Following the treatments, there was
no indication of systemic exposure to Domiphen Bromide.
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “I am thrilled to
announce promising outcomes for MCZ-DB, showcasing outstanding
safety and tolerability in both cohorts. Additionally, the low dose
demonstrated significant superiority over the active control by day
291. The primary objective of this
trial was to identify the most effective dosage of DB (0.14% or
0.29%) for treating VVC. With these encouraging findings, we are
now prepared to engage in discussions with relevant authorities for
further clinical investigations”.
About severe and recurring VVC and
MCZ-DB
VVC is a prevalent vaginal fungal infection primarily caused by the
yeast Candida albicans, affecting as many as one in every two women
during their life, with about 175 million units (treatments) sold
annually worldwide2. Up to 20% of VVC patients develop
severe to recurrent VVC characterized by reinfection occurring 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 projected up to $14.39 billion annually by
20303. 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
toxicity4. 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 infections5. 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 destroying fungal activity and
potentially 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 VVC6.
About Hyloris Pharmaceuticals
SA
Hyloris is a specialty biopharma company focused on innovating,
reinventing, and optimizing existing medications to address
important healthcare needs and deliver relevant improvements for
patients, healthcare professionals and payors.
The Company’s development strategy primarily focuses on leveraging
established regulatory pathways, such as the FDA’s 505(b)2 pathway
in the U.S or equivalent regulatory frameworks in other regions
which are specifically designed for pharmaceuticals for which
safety and efficacy of the molecule have already been established.
This approach can reduce the clinical burden required for market
entry, and significantly shorten the development timelines, leading
to reduced costs and risks.
Hyloris has built a broad, patented portfolio of
18 reformulated and repurposed value-added medicines that have the
potential to offer significant advantages over existing
alternatives. Two products are currently in early phases of
commercialization in collaboration with commercial partners:
Sotalol IV for the treatment of atrial fibrillation, and Maxigesic®
IV, a non-opioid post-operative pain treatment. In addition to its
core strategic focus, the Company has 1 approved high barrier
generic product launched in the U.S. and 2 high barrier generic
products in development.
Hyloris is based in Liège, Belgium. For more
information, visit www.hyloris.com and follow-us
on LinkedIn.
About Purna Female Healthcare
NV
Purna Female Healthcare is a spin-off of Purna Pharmaceuticals, a
family-owned Belgian company specialized in the development and
manufacturing of pharmaceutical products. With proficiency in every
facet of drug development and manufacturing, Purna Pharmaceuticals
can seamlessly progress from the initial stages of innovative ideas
or technologies to the industrial production of the final
product.
For more information, contact
Hyloris:
Stijn Van Rompay, CEO
Stijn.Vanrompay@hyloris.com
+32 (0)4 346 02 07
Jean-Luc Vandebroek, CFO
Jean-luc.vandebroek@hyloris.com
+32 (0)478 27 68 42
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 p-value <0.05
2 FIOR Markets 2019; Global Info Research; IMS
3 D.W Denning et al.. Lancet Infectious Diseases
(2018); D Rosati D et al., An Immunological
Perspective, Microorganisms (2020)
4 P.G. Pappas et al., Clinical Infectious Diseases
(2016); J.D. Sobel et al., Expert Opinion on
Pharmacotherapy (2018)
5 J Tits., J et al., Antimicrob. Agents Chemother
(2020); K. De Cremer et al., Antimicrobial agents and
chemotherapy (2015)
6 Manuscript for scientific paper submitted
- 20240130 HY-Purna-EN_FINAL
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