Hyloris Pharmaceuticals Broadens Pipeline
with a Proprietary Intranasal Product Candidate of a TRPV11 agonist
(HY-083) for Idiopathic Rhinitis
-
Hyloris targets a condition that affects up to 7% of the global
adult population without any satisfactory treatment currently
available
-
The addition of this new value-added product candidate brings
Hyloris toward its goal of 30 assets before 2025
Conference call Wednesday November 23rd at 4pm
CET/10AM EST (details below)
Regulated Information - Inside Information - Liège,
Belgium – 22
November
2022 –
6PM CET – Hyloris
Pharmaceuticals SA (Euronext Brussels: HYL), a specialty
biopharma company committed to addressing unmet medical needs
through reinventing existing medications, today announced the
development of a new proprietary formulation – a TRPV1 agonist -
administered intranasally as a spray, to treat idiopathic
rhinitis.
Idiopathic rhinitis is a medical disorder characterized by a
collection of nasal symptoms that resemble nasal allergies and hay
fever (allergic rhinitis) but are not caused by a known cause like
allergens or infectious triggers. Idiopathic rhinitis features an
overexpression of TRPV1 in the nasal mucosa giving rise to nasal
obstruction, rhinorrhoea (colloquially: a runny nose), and/or
sneezing.
Hyloris’ treatment approach is to activate and depolarize TRPV1
receptors leading to restoration of a normal function of the nasal
mucosa. Current treatment options for idiopathic rhinitis are not
consistently successful. This leads to unnecessary and often
ineffective surgery for severe cases, such as nasal septal
corrections and/or inferior turbinate reductions.
Stijn Van
Rompay, Chief Executive Officer
of Hyloris, commented:
“We are pleased to announce another value-added
product candidate to add to our portfolio of programs. This
proprietary intranasal product candidate with a well-known
mechanism of action should solve a large unmet medical need and
offer patients rapid and sustainable relief.”
“Our focused strategy to acquire new value-added
product candidates has brought us closer to our goal of reaching 30
assets in our portfolio before 2025. This has solidified our
positioning to be a market leader in the development of value-added
product candidates utilizing the expedited and cost-effective
505(b)2 regulatory strategy in the U.S. We aim to develop a
low-dose application that can be administered locally via a nasal
spray first in Europe before pursing global roll-out.”
Peter Hellings, Full Professor at the
University of Leuven, Belgium, and Chair of EUFOREA (European Forum
for Research and Education in Allergy and Airways
diseases), commented:
”Idiopathic rhinitis is a burdensome condition of the nasal mucosa
with no satisfactory medical or surgical treatment, where attempted
symptom management fails in nearly all cases. It is a chronic
condition associated with interrupted sleep, irritability and poor
concentration. Hence, it can be a severe detriment to quality of
life and capacity to work.”
“Current treatment tries to combine an antihistamine and an
intranasal corticosteroid used in other rhinitis types which has
yielded only poor results. For severe cases, patients often turn to
surgery which is not a cure either. Our strategy is to
defunctionalize the overactivated sensory nerve fibres by a
targeted, local acting medicinal product and present clinical
evidence of efficacy and safety.”
CONFERENCE
CALL
Hyloris will host a conference call on Wednesday
November 23rd at 4PM CET/10AM EST, in attendance of Prof. Dr. Peter
Hellings. The webcast may be accessed via Microsoft Teams using the
following details or by clicking here.
Join on your computer or mobile
appMeeting ID : 320 762 272 784 Passcode : 3VU5RS
Or call in (audio only) +32 4 290 22 87Phone
Conference ID: 151 901 636#
About Rhinitis
Rhinitis is defined as the presence of at least one of the
following symptoms for more than 1 hour per day: nasal
congestion/obstruction, rhinorrhoea, sneezing, and nasal
itching.
Chronic rhinitis can be divided into 3
phenotypes: allergic, infectious and non-allergic/non-infectious.
For allergic and /infectious rhinitis, current medicinal products
are available such as decongestant spray/tablets, antihistamines or
corticosteroids.
Idiopathic rhinitis is the largest group within
the non-allergic/non-infectious rhinitis group. It occurs in around
7% of the total population, representing an estimated 19 million
people in the US alone. 13% of them have moderate to severe
idiopathic rhinitis, leading them to actively seek specialist
treatment and, who can not provide consistent treatment with the
currently available therapy options.
These patients typically live through several
years of failed treatment options, adding frustration and wasted
expenses to the medical symptoms impacting their quality of life.
Rapid relief through a nasal spray should reduce overall treatment
costs, improve quality of life and make potentially unsuccessful
surgical procedures redundant.
About Hyloris PharmaceuticalsHyloris 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 14 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 four 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 Pharmaceuticals:Stijn Van Rompay,
CEOstijn.vanrompay@hyloris.com+32 (0)4 346 02 07Jean-Luc
Vandebroek, CFOjean-luc.vandebroek@hyloris.com+32 (0)478 27 68
42Sven Watthy, Investor Relations & Communications
managerSven.watthy@hyloris.com+32 (0)499 71 15 29Disclaimer
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 TRPV1 is Transient Receptor Potential cation channel subfamily
V member 1. The function of TRPV1 is detection and regulation
of body temperature. In addition, TRPV1 provides a sensation
of scalding heat and pain (nociception)
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