Aptorum Group Announces Further Positive Interim Results of the Phase 1 Clinical Trial of ALS-4 Targeting Staphylococcus aure...
July 12 2021 - 08:00AM
Business Wire
Regulatory News:
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM)
(“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical
company, announces further positive results of its ongoing Phase 1
clinical trial for ALS-4 (a first in-class anti-virulence approach
based small molecule targeting Staphylococcus aureus, including,
but not limited to Methicillin Resistant Staphylococcus Aureus
(“MRSA”)). Specifically, two additional cohorts (Cohort C & D)
of the single ascending dose (SAD) portion of the Phase 1 trial in
healthy male and female adult subjects have been completed with no
serious adverse events observed.1
ALS-4’s first-in-human Phase 1 trial is a randomized,
double-blinded, placebo-controlled, single (SAD) and multiple
ascending dose (MAD) study designed to evaluate safety,
tolerability, and pharmacokinetics of orally administered ALS-4 in
healthy male and female adult volunteers. Dosing and safety reviews
of Cohort C (100mg) and Cohort D (200mg) have been completed, with
8 subjects (6 received ALS-4 and 2 received placebo) were dosed in
each cohort. We are pleased to announce that no human subjects were
dropped out of the studies and no Serious Adverse Events (SAE) were
observed. In addition, no clinically relevant changes in respect of
vital signs, electrocardiogram (ECG), clinical laboratory test
results and physical examinations were observed compared to
baselines. Our SAD is still ongoing to gain additional insights as
to the effect of food on bioavailability as well as
pharmacokinetics. On this basis, we plan to proceed to MAD in Q3,
2021.2
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 approach targeting staphylococcus
aureus including MRSA. ALS-4 targets the antimicrobial resistant
properties of the bacteria and is believed to render the bacteria
highly susceptible to the host’s immune clearance. ALS-4 is
targeted for potential administration on a standalone or on a
combination basis with other existing antibiotics such as
vancomycin.
About Aptorum Group
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a
clinical stage biopharmaceutical company dedicated to the
discovery, development and commercialization of therapeutic assets
to treat diseases with unmet medical needs, particularly in
oncology (including orphan oncology indications) and infectious
diseases. The pipeline of Aptorum is also enriched through (i) the
establishment of drug discovery platforms that enable the discovery
of new therapeutics assets through, e.g. systematic screening of
existing approved drug molecules, and microbiome-based research
platform for treatments of metabolic diseases; and (ii) the
co-development of a novel molecular-based rapid pathogen
identification and detection diagnostics technology with Accelerate
Technologies Pte Ltd, commercialization arm of the Singapore’s
Agency for Science, Technology and Research.
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 Dosing and safety reviews of Cohort A (25mg) and Cohort B
(50mg) have been completed in May 2021 (see
https://ir.aptorumgroup.com/news-releases/news-release-details/aptorum-group-announces-positive-interim-phase-i-clinical-trial).
2 We plan to conduct 5 total cohorts (plus one optional cohort)
for SAD and, thereafter, 3 cohorts for MAD (multiple ascending
dose) in Phase 1. As of today, we have completed 4 of the 5
mandatory cohorts for SAD.
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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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