Hyloris Enrolls First Patient in Phase 3 Clinical Trial for its
Proprietary Mouth Rinse to Control Incidences of Bleeding Related
to Dental Procedures
-
Innovative oral care solution aims to benefit patients taking blood
thinning medications, who have an increased risk of prolonged
bleeding during and after dental procedures
-
Approximately 280 patients in the EU and U.S. will be randomized to
receive either tranexamic acid oral solution or placebo
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Last patient out expected around end of 2024
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Study results expected first half of 2025
Liège, Belgium – February, 14 2024 – 6PM CET –
Non-regulated information - 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 a pivotal Phase 3 clinical trial for Tranexamic Acid
Oral Rinse.
Hyloris’ product candidate is a new treatment for use in
patients on anti-coagulant therapies (blood thinners) undergoing
dental procedures with a risk of excessive bleeding. It is an oral
solution containing the locally-acting antifibrinolytic agent
tranexamic acid. Positive data in a Phase 1 pharmacokinetic (PK)
trial in healthy subjects suggested the treatment was well
tolerated under varied conditions with no serious adverse events
following tooth extraction, while effectively controlling
procedural bleeding without delaying clot formation. Data from this
Phase 1 allowed Hyloris to define the optimal administration
regimen for its proprietary oral solution for the current Phase 3
trial.
Stijn Van Rompay, Chief Executive Officer of
Hyloris, commented: “Preventing bleeding with a
convenient oral rinse to be self-administered at home, at work or
in a dental office would improve patient outcomes after generally
unpleasant tooth extraction procedures. The health care system is
also served by shorter times to discharge and reducing the
incidence of clinically relevant bleeding and thus the need for
hospitalization.”
“Our proprietary mouth rinse demonstrates once again the
opportunity that lies in reinventing existing medicines. We believe
the potential for Tranexamic Acid Oral Rinse reaches even further
than what is currently being tested, and we are exploring
opportunities in broader related indications in patients undergoing
oral surgical procedures with or without bleeding disorders that
could benefit from a locally acting antifibrinolytic
agent.”
Close to 2 in 3 U.S. adults aged 18-64 visit dental
professionals every year1. Around 8 million people in
the U.S. take blood thinner medication2. A market study
conducted by Hyloris indicated that more than 80% of U.S. based
dental professionals would stock a locally acting tranexamic acid
mouth rinse to use during and following relevant procedures such as
tooth extractions.
Hyloris will seek regulatory approval in the United States
first, before expanding to other territories. Conditional to a
successful clinical study program, Hyloris expects to license the
product candidate to a partner for commercialization in the
U.S.
About this Phase 3 trial
This randomized, double-blind, multicenter, placebo-controlled
Phase 3 trial is designed to demonstrate efficacy, safety and
acceptability of the oral solution containing tranexamic acid to
prevent possible oral haemorrhaging in patients treated with
anticoagulants (blood thinners) and undergoing extraction of one or
more teeth.
This study will measure and compare efficacy of the proprietary
oral solution containing tranexamic acid against placebo in
reducing the number of both clinically relevant and irrelevant
bleeds in patients treated with anticoagulants and undergoing tooth
extraction. Clinically relevant bleeds are defined as the need for
medical attention or intervention.
An estimated 280 patients will be recruited at approximately 20
clinical sites across Europe and the United States. Eligible
patients will be randomized to receive tranexamic acid oral
solution or placebo for 7 days and followed for approximately one
month. Recruitment is expected to be completed around the end of
2024 with final results available in the first half of 2025.
About Tranexamic Acid Oral Rinse
Hyloris’ proprietary reformulated oral rinse was developed for
use in minor surgical procedures with complications/bleedings. The
formulation can be used by dental care professionals for patients
on anti-coagulant therapies who benefit from the opportunity to
continue their anti-coagulant treatments when scheduled for dental
procedures. By addressing the unique challenges faced by
individuals on blood thinners, this oral care solution seeks to
enhance the overall dental experience and improve the oral health
of these patients.
About Tranexamic Acid
Tranexamic acid is an antifibrinolytic agent that has been used
for decades to reduce or prevent postoperative bleeding in patients
with bleeding problems. The drug is currently approved for
intravenous administration (CYKLOKAPRON® IV) in the U.S. for
reduction or prevention of bleeding in patients having a high risk
of intra and post-operative haemorrhage (during general and oral
surgery, such as tooth extractions) due to a bleeding disorder such
as haemophilia (as indicated). The drug is also approved in the
U.S. as an oral tablet (LYSTEDA®) for cyclic heavy menstrual
bleeding.
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.
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
Jessica McHargue, Investor Relations & Communications
Manager
jessica.mchargue@hyloris.com
+1 (919) 451 4740
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
Company 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
https://www.cdc.gov/nchs/products/databriefs/db412.htm
2 IBM Truven Health Analytics, 12 months ending December
31, 2018 for Commercial, Medicare and Medicaid patients (October
24, 2019)
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