IntelGenx Announces Enrollment Reaches Halfway Mark in ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
08 Septembre 2022 - 2:00PM
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or
"IntelGenx") today announced that patient enrollment in the ongoing
Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in
patients with mild to moderate Alzheimer’s Disease (“AD”) has
reached the halfway mark.
This proof-of-concept study currently includes
six clinical research sites with the potential of adding two more
sites in the coming month, all of which are expected to enroll a
total of approximately 70 patients.
"We are encouraged by the speed with which AD
patients are enrolling in this trial following the resumption of
our recruiting efforts," said Dr. Horst Zerbe, IntelGenx’s CEO. “We
continue to work diligently to improve the recruitment rate even
further, and anticipate completing enrollment before the end of
2022.”
About Montelukast
VersaFilm®
Montelukast is a leukotriene receptor antagonist
that was approved by the U.S. Food and Drug Administration in 1997
for the treatment of asthma and seasonal allergic rhinitis.
IntelGenx is working to repurpose Montelukast as a therapeutic to
treat neurodegenerative diseases by re-formulating the drug into an
oral film-based product. IntelGenx's proprietary VersaFilm®
technology is especially suited for special needs patient
populations, and the Montelukast VersaFilm® product offers many
distinct advantages over tablets for Alzheimer’s Disease patients,
including the avoidance and minimization of first-pass-effects,
ease of administration, improved API bioavailability, lower dosing
and toxicity, better acceptability and improved compliance.
In Phase 1 studies, IntelGenx demonstrated that
an oral film formulation of Montelukast is safe and tolerable in
healthy subjects, reduces the first-pass-effect and has a 52%
higher bioavailability compared to the regular Montelukast tablet,
demonstrating a clear advantage of delivering Montelukast via film.
IntelGenx's oral film also crossed the blood-brain barrier, an
essential feature for treating degenerative brain diseases.
About IntelGenx
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
films.
IntelGenx’s superior film technologies,
including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal
VevaDerm™, allow for next generation pharmaceutical products that
address unmet medical needs. IntelGenx’s innovative product
pipeline offers significant benefits to patients and physicians for
many therapeutic conditions.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility offers full service by
providing lab-scale to pilot- and commercial-scale production. For
more information, visit www.intelgenx.com.
Forward-Looking Information and
Statements
This document may contain forward-looking
information about IntelGenx's operating results and business
prospects that involve substantial risks and uncertainties.
Statements that are not purely historical are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, but are not
limited to, statements about IntelGenx's plans, objectives,
expectations, strategies, intentions or other characterizations of
future events or circumstances and are generally identified by the
words "may," "expects," "anticipates," "intends," "plans,"
"believes," "seeks," "estimates," "could," "would," and similar
expressions. All forward looking statements are expressly qualified
in their entirety by this cautionary statement. Because these
forward-looking statements are subject to a number of risks and
uncertainties, IntelGenx's actual results could differ materially
from those expressed or implied by these forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed under
the heading "Risk Factors" in IntelGenx's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen KilmerInvestor Relations(647)
872-4849stephen@kilmerlucas.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514)
331-7440 ext 203andre@intelgenx.com
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