Aptorum Group Announces Submission of Clinical Trial Application for ALS-4, an Orally Administered Small Molecule Drug for th...
December 21 2020 - 6:00AM
Business Wire
Regulatory News:
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM)
(“Aptorum Group” or “Aptorum”), a biopharmaceutical company focused
on novel technologies for the treatment of a variety of medical
conditions including infectious diseases, announced that the
company, through its wholly owned subsidiary Aptorum International
Limited, has submitted a Clinical Trial Application (CTA) with the
Public Health Agency of Canada (Health Canada) to conduct a Phase 1
clinical trial of ALS-4, an orally administered small molecule drug
for the treatment of infections caused by Staphylococcus aureus
including Methicillin-resistant Staphylococcus aureus (MRSA).
Pending Health Canada’s approval, the Phase 1 trial is designed to
test the safety, tolerability and pharmacokinetics of ALS-4 in
healthy volunteers.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of
Aptorum Group, commented: “Further to our previous update in
September 2020, we are pleased to announce this CTA submission
which represents a major development milestone for our ALS-4
antimicrobial program. ALS-4 is a novel small molecule adopting an
anti-virulence (non-antibiotic) approach to address the growing
unmet medical needs of infections caused by Staphylococcus aureus.
ALS-4 is an orally administered drug and thereby aligning with
global healthcare policy to actively promote the switch from an IV
to oral based antimicrobial treatment1,2,3. As shown in our
internal preclinical data and subject to further clinical trials,
ALS-4 can be potentially used on a standalone basis or in
combination with existing antibiotics (for example, vancomycin)
with the aim to reduce mortality and morbidity of the infected
patients especially in severe cases. We believe that our orally
administered ALS-4 drug can potentially also tackle a variety of
infections caused by Staphylococcus aureus, including (but not
limited to) MRSA bacteremia and skin & soft tissue infections,
subject to the respective clinical trials.”
The Phase 1 clinical trial is planned to be conducted in Canada
and targeted to recruit up to 48 and 32 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 first-in-class orally administered small molecule
drug based on an anti-virulence (non-antibiotic) approach targeting
Staphylococcus aureus including MRSA. ALS-4 targets to inhibit the
virulence properties of the bacteria and render them highly
susceptible to the host’s immune clearance and also potentially
provide added benefits in combination with existing
antibiotics.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a
biopharmaceutical 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. In addition to the above main focus, the
company is also pursuing therapeutic and diagnostic projects in
neurology, gastroenterology, metabolic disorders, women’s health
and other disease areas. Aptorum also has projects focused on
surgical robotics and natural supplement 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.
1
https://www.gloshospitals.nhs.uk/gps/antimicrobial-resources/adult-antibiotic-treatment-guidelines-site-infection/iv-oral-switch-guideline/
and
https://www.dbth.nhs.uk/wp-content/uploads/2017/10/IV-to-oral-switch-and-5-day-stop-policy.pdf
2
https://hgs.uhb.nhs.uk/wp-content/uploads/Guidelines-for-Antimicrobial-Prescribing-v5.0.pdf
3
https://www.jwatch.org/na48403/2019/02/12/sequential-intravenous-oral-treatment-mrsa-bacteremia
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version on businesswire.com: https://www.businesswire.com/news/home/20201221005196/en/
Inquiries: 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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