Algernon Pharmaceuticals Announces Enrollment of Final Patient in its Multinational Phase 2b/3 Human Study of Ifenprodil for ...
November 30 2020 - 8:00AM
Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW)
(OTCQB: AGNPF) (the “
Company” or
“
Algernon”) a clinical stage pharmaceutical
development company, is pleased to announce that the final patient
has been enrolled in its multinational Phase 2b/3 human study of
NP-120 (Ifenprodil) for the treatment of COVID-19. The aggregate
total number of patients enrolled from all countries participating
in the study is 168.
The Company recently announced that it would be
providing interim data from 75 patients from day 15 of their
participation in the study, in the first week of December. Since
the treatment period after enrollment is two weeks, with a two-week
follow-up thereafter, the interim data readout date has now been
moved to the third week of December to ensure that the patients who
recently enrolled, can complete their treatment regimen before data
is presented.
The Company will update the market shortly on
the date when the final data readout will be available.
“I want to thank to the entire AGN team,
including all of our clinical trial investigators and their staff,
for helping us reach the goal of 100% patient enrollment,” said
Christopher J. Moreau CEO of Algernon Pharmaceuticals. “Our next
big step is to see how the preliminary data is trending and we
remain hopeful it will show that Ifenprodil is reducing both the
severity and duration of a COVID-19 infection. Even with the recent
success of certain vaccines in clinical trials, medical doctors
need to have effective therapeutic treatment options as well.”
The Company advises that it is not making any
express or implied claims that Ifenprodil has the ability to
eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at
this time.
Phase 2b/3 Study
Protocol Summary
The Company’s multinational Phase 2b/3 human
trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3
Study of the Safety and Efficacy of NP-120 (Ifenprodil) for
the Treatment of Hospitalized Patients with Confirmed COVID-19
Disease."
The trial has begun as a Phase 2b study of an
aggregate of 150 patients. With positive preliminary data, the
clinical trial will move directly into a Phase 3 trial. The data
from the Phase 2b study will determine the number of patients
needed to reach statistical significance in the Phase 3
trial.
Patients are being randomized in a one-to-one
manner and will either be treated using an existing standard of
care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg
tablet three-times daily) for one arm or standard of care plus
Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily)
for two weeks.
Over the testing period, doctors will observe
whether there is an improvement in a number of secondary endpoints,
including mortality, blood oxygen levels, time spent in intensive
care and time to mechanical ventilation.
About NP-120 (Ifenprodil)
NP-120 (Ifenprodil) is
an N-methyl-D-aspartate (NMDA) receptor antagonist
specifically targeting the NMDA-type subunit 2B (Glu2NB).
Ifenprodil prevents glutamate signalling. The NMDA receptor is
found on many tissues including lung cells, T-cells, and
neutrophils.
The Company believes Ifenprodil can reduce the
infiltration of neutrophils and T-cells into the lungs where they
can release glutamate and cytokines respectively. The latter can
result in the highly problematic cytokine storm that contributes to
the loss of lung function and ultimately death as has been reported
in COVID-19 infected patients.
About Algernon Pharmaceuticals
Inc.
Algernon is a drug re-purposing company that
investigates safe, already approved drugs for new disease
applications, moving them efficiently and safely into new human
trials, developing new formulations and seeking new regulatory
approvals in global markets. Algernon specifically investigates
compounds that have never been approved in the U.S. or Europe to
avoid off label prescription writing.
Algernon has filed new intellectual property
rights globally for NP-120 (Ifenprodil) for the treatment of
respiratory diseases and is working to develop a proprietary
injectable and slow release formulation.
CONTACT INFORMATION
Christopher J. MoreauCEOAlgernon Pharmaceuticals
Inc.604.398.4175 ext
701info@algernonpharmaceuticals.cominvestors@algernonpharmaceuticals.comwww.algernonpharmaceuticals.com
Neither the Canadian Securities Exchange
nor its Market Regulator (as that term is defined in the policies
of the Canadian Securities Exchange) accepts responsibility for the
adequacy or accuracy of this release. The Canadian Securities
Exchange has not in any way passed upon the merits of the proposed
transaction and has neither approved nor disapproved the contents
of this press release.
CAUTIONARY DISCLAIMER STATEMENT: No Securities
Exchange has reviewed nor accepts responsibility for the adequacy
or accuracy of the content of this news release. This news release
contains forward-looking statements relating to product
development, licensing, commercialization and regulatory compliance
issues and other statements that are not historical facts.
Forward-looking statements are often identified by terms such as
“will”, “may”, “should”, “anticipate”, “expects” and similar
expressions. All statements other than statements of historical
fact, included in this release are forward-looking statements that
involve risks and uncertainties. There can be no assurance that
such statements will prove to be accurate and actual results and
future events could differ materially from those anticipated in
such statements. Important factors that could cause actual results
to differ materially from the Company’s expectations include the
failure to satisfy the conditions of the relevant securities
exchange(s) and other risks detailed from time to time in the
filings made by the Company with securities regulations. The reader
is cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or
circumstances may cause actual results to differ materially from
those predicted, as a result of numerous known and unknown risks,
uncertainties, and other factors, many of which are beyond the
control of the Company. The reader is cautioned not to place undue
reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of
preparation, may prove to be incorrect and actual results may
differ materially from those anticipated. Forward-looking
statements contained in this news release are expressly qualified
by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news
release and the Company will update or revise publicly any of the
included forward-looking statements as expressly required by
applicable law.
Algernon Pharmaceuticals (CSE:AGN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Algernon Pharmaceuticals (CSE:AGN)
Historical Stock Chart
From Dec 2023 to Dec 2024