Aptorum Group Receives Clearance from Health Canada to Initiate a Phase 1 Clinical Trial for ALS-4, a Small Molecule Drug for...
January 20 2021 - 6:00AM
Business Wire
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) )
(“Aptorum Group” or “Aptorum”), a biopharmaceutical company focused
on novel technologies including the targeting of infectious
diseases, announced that the company, through its wholly owned
subsidiary, Aptorum International Limited, has received clearance
from the Public Health Agency of Canada (Health Canada) regarding
the Clinical Trial Application (CTA) to commence a Phase 1 study of
ALS-4, an orally administered small molecule drug intended to treat
infections caused by Staphylococcus aureus including MRSA.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of
Aptorum Group, commented, “The clearance of our CTA application for
ALS-4 drug represents a significant milestone for the company and
one of a number of targeted strategic goals for 2021. This
milestone supports the transition of Aptorum Group to a
clinical-stage company and reflects the potential of our scientific
rigor and novel approach of our products. We are dedicated to
delivering novel therapeutics in the field of growing unmet medical
needs of infections starting with Staphylococcus aureus.”
The Phase 1 clinical trial is planned to be conducted in Canada
and targeted to recruit up to 48 and 24 healthy volunteers for the
single-ascending dose (SAD) and multiple- ascending dose (MAD)
cohorts, respectively. The primary objective of the trial is to
evaluate the safety and tolerability of SAD and MAD of ALS-4
administered orally to healthy subjects. The secondary objective is
to assess the pharmacokinetic profile of SAD and MAD of ALS-4
administered orally to healthy subjects.
About ALS-4
As part of Aptorum Group’s Acticule infectious disease platform,
ALS-4 is a novel orally administered first-in-class small molecule
that was developed based on an anti-virulence approach targeting
Staphylococcus aureus including MRSA. ALS-4 can potentially lessen
antimicrobial resistance via lowering selection pressure and render
the bacteria to become highly susceptible to the host’s immune
clearance. ALS-4 is targeted for potential administration both on a
standalone or a combined basis with other existing antibiotics such
as vancomycin.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a
pharmaceutical company dedicated to the discovery, development and
commercializing of therapeutic assets to treat diseases with unmet
medical needs, particularly infectious diseases and cancers
(including orphan oncology indications). The pipeline of Aptorum is
also enriched through the establishment of drug discovery platforms
that enable the discovery of new therapeutics assets through
programs such as the systematic screening of existing approved drug
molecules and microbiome-based research platform for treatments of
metabolic diseases. Aptorum also has projects focused on microbiome
research and the commercialization of a natural supplement product
targeted for women undergoing menopause and experiencing related
symptoms.
For more information about Aptorum Group, please visit
www.aptorumgroup.com.
Disclaimer and Forward-Looking Statements
This press release does not constitute an offer to sell or a
solicitation of offers to buy any securities of Aptorum Group.
This press release includes statements concerning Aptorum Group
Limited and its future expectations, plans and prospects that
constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. For this purpose,
any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. In
some cases, you can identify forward-looking statements by terms
such as “may,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential,” or “continue,” or
the negative of these terms or other similar expressions. Aptorum
Group has based these forward-looking statements, which include
statements regarding projected timelines for application
submissions and trials, largely on its current expectations and
projections about future events and trends that it believes may
affect its business, financial condition and results of operations.
These forward-looking statements speak only as of the date of this
press release and are subject to a number of risks, uncertainties
and assumptions including, without limitation, risks related to its
announced management and organizational changes, the continued
service and availability of key personnel, its ability to expand
its product assortments by offering additional products for
additional consumer segments, development results, the company’s
anticipated growth strategies, anticipated trends and challenges in
its business, and its expectations regarding, and the stability of,
its supply chain, and the risks more fully described in Aptorum
Group’s Form 20-F and other filings that Aptorum Group may make
with the SEC in the future, as well as the prospectus that received
the French Autorité des Marchés Financiers visa n°20-352 on 16 July
2020.
As a result, the projections included in such forward-looking
statements are subject to change and actual results may differ
materially from those described herein. Aptorum Group assumes no
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
otherwise.
This announcement is not a prospectus within the meaning of the
Regulation (EU) n°2017/1129 of 14 June 2017 as amended by
Regulations Delegated (EU) n°2019/980 of 14 March 2019 and
n°2019/979 of 14 March 2019.
This press release is provided “as is” without any
representation or warranty of any kind.
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Aptorum Group Limited Investor Relations Department:
investor.relations@aptorumgroup.com +44 20 80929299
Redchip – Financial Communications United States Investor
relations Dave Gentry dave@redchip.com +1 407 491 4498
Actifin – Financial Communications Europe Investor relations
Ghislaine Gasparetto ggasparetto@actifin.fr +33 1 56 88 11 22
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