Patient Screening to Resume in IntelGenx’s ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx” or the
“Company”)), a leader in pharmaceutical films, today announced its
intention to resume patient screening in the ongoing Montelukast
VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild
to moderate Alzheimer’s Disease (“AD”) following Health Canada’s
(“HC”) issuance of a No Objection Letter (“NOL”) in response to
IntelGenx’s amended Clinical Trial Application.
As previously disclosed in Q1-2020, IntelGenx
received HC authorization to proceed with an amended BUENA clinical
trial protocol, which enabled the Company to continue the trial at
an increased daily dose. However, because the target study
population in the BUENA study is considered to be a higher risk
group for severe illness from COVID-19, and out of concern for the
health and safety of clinical trial staff, IntelGenx informed HC in
the second quarter of 2020 that the study was on a temporary
recruitment hold. This NOL now paves the way for patient screening
under the amended protocol to resume in October 2021.
“As treatment options remain limited, and no
approved drugs are disease modifying, we are very excited to resume
this trial and evaluate the potential of Montelukast as a
much-needed treatment for AD patients,” said Dr. Horst Zerbe,
IntelGenx’s CEO. “We are in the fortunate position that the
convertible notes offering that closed in Q3-2021 provided us with
the dedicated financial resources required to complete this
important study, and expect to resume patient screening activities
as soon as practicable this month.”
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.
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
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
This document may contain forward-looking
information or forward-looking statements within the meaning of
applicable United States and Canadian securities laws
(collectively, “forward-looking statements”). These statements are
statements that are not purely historical and include, but are not
limited to, statements about the advancement of the New Loans and
the obtaining of the TSX’s final approval to list its Common Shares
on the TSX. 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
Factors that could cause or contribute to such
differences include, but are not limited to, the factors 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 and www.sedar.com.
Although the Company believes that the
expectations and assumptions on which forward-looking statements
are based are reasonable, readers of this press release are
cautioned not to rely unduly on such forward-looking statements
since no assurance can be given that they will prove to be correct.
The Company does not undertake any obligation to update or revise
any forward-looking statements, whether as a result of events or
circumstances occurring after the date of this press release,
unless so required by legislation.
Source: IntelGenx Technologies Corp.
Stephen KilmerInvestor Relations(647)
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext email@example.com
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