Hyloris Announces Positive Clinical Study Results for Valacyclovir Oral Suspension (HY-029)
26 Dezembro 2023 - 2:00PM
Hyloris Announces Positive Clinical Study Results for Valacyclovir
Oral Suspension (HY-029)
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Valacyclovir is an Antiviral Medication that is Commonly Used to
Treat Infections Caused by Herpes Viruses
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Clinical Study Demonstrates Comparable Relative Bioavailability to
Valaciclovir Tablets under fasted conditions
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NDA submission1 (NDA) to the U.S. Food & Drug Administration
(FDA) expected in 2024
Liège, Belgium – December, 26 2023 – 6PM 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 from a
pivotal clinical study for its proprietary Valacyclovir Oral
Suspension. It allows for further preparation of a NDA1 for
submission to the FDA expected in 2024.
Stijn Van Rompay, Chief Executive Officer of Hyloris,
commented: “We are one step closer to bringing a new and
improved mode of administration for this well-known molecule,
prescribed more than 5 million times annually in the U.S2. Multiple
benefits are to be expected from our novel formulation which
addresses potential dosing inaccuracies associated with crushing
tablets, aiming to enhance stability and storability, ultimately
contributing to increased patient compliance and improved quality
of life."
About the pivotal study
The primary objective was to compare the proprietary
Valacyclovir Oral Suspension (200 mg/mL) with Valtrex® tablets (50
mg/mL) prepared as an extemporaneous suspension3. The relative
bioavailability of valacyclovir and acyclovir4 was measured after
administration under fasted conditions5. In addition, the effect of
food on the bioavailability of acyclovir after administration of
proprietary Valacyclovir Oral Suspension (200 mg/mL) was
assessed.
About Valacyclovir
Valacyclovir, currently commercialized as a solid oral in the
U.S., is used to treat herpes virus infections, including herpes
labialis (also known as cold sores), herpes zoster (also known as
shingles), and herpes simplex (also known as genital herpes) in
adults. For pediatric patients, the drug was approved for cold
sores (herpes labialis) and chickenpox. Valacyclovir is available
by prescription only, and the dosage and duration of treatment
depend on the specific condition being treated and the individual
patient's medical history.
Estimates indicate 5,5 million prescriptions6 to over 2,4
million patients in the U.S. in 2020. In 2022 more than 560 million
tablets were sold, growing at a CAGR of 5%7.
About HylorisHyloris 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. Hyloris has built a broad, patented portfolio of 17
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 1 approved high barrier generics product launched in the U.S.
and 2 high barrier generic products in development.
Two products are currently in initial phases of
commercialization 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, contact Hyloris:Stijn Van
Rompay, CEOStijn.vanrompay@hyloris.com+32 (0)4 346 02 07
Jean-Luc Vandebroek, CFOJean-luc.vandebroek@hyloris.com+32
(0)478 27 68 42
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 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 After completion of the required stability and clinical
activities.2 Valacyclovir - Drug Usage Statistics, ClinCalc
DrugStats Database.3 An extemporaneous preparation (compound) is a
drug or mixture of drugs prepared or compounded in a pharmacy
according to the order of a prescriber.4 Valacyclovir is nearly
completely converted to acyclovir by first-pass metabolism.5 The
abstinence of food and drinks except water for a period of time
prior to dosing.6 Valacyclovir - Drug Usage Statistics, ClinCalc
DrugStats Database.7 Source: IQVIA.
- HY-029 Pivotal Study success-FINAL_en
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