Aptorum Group Announces Completion of End of Phase 1 (EOP1) Meeting with US FDA on its SACT-1, a Repurposed Small Molecule Drug Targeting Neuroblastoma
03 Mars 2023 - 1:30PM
Business Wire
Regulatory News:
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM)
(“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical
company, announces the completion of an end of Phase 1 (EOP1)
meeting with the US Food and Drug Administration (“US FDA”). SACT-1
is a repurposed small molecule drug formulated in oral suspension
targeting neuroblastoma in pediatric patients and has also received
orphan drug designation previously from the US FDA.
The EOP1 meeting was focused on gaining alignment with the US
FDA regarding the clinical and regulatory pathway for SACT-1 for
the treatment of neuroblastoma in pediatric patients aged 2-18. The
FDA generally agreed with the chemistry-manufacturing-control (CMC)
strategy and our proposed clinical development plan for Phase 1/2
trials.
Dr. Clark Cheng, Chief Medical Officer and Executive Director of
Aptorum Group, commented: “We are pleased to announce the
completion of End of Phase 1 Meeting with US FDA and this
represents another key milestone for the company and one of the
targeted strategic goals for the year of 2023. With additional
supportive information from US FDA on the clinical development of
SACT-1, this supports the continued focus of Aptorum Group to
embark on the exciting Phase 1/2 clinical trials for SACT-1,
subject to further FDA’s clearance of the final clinical
protocol.”
About SACT-1
SACT-1 is an oral suspension based repurposed small molecule
drug formulated in oral suspension to target neuroblastoma.
SACT-1’s mechanism has been investigated in our preclinical studies
to enhance tumor cell death and suppress MYCN expression (a common
clinical diagnosis in high-risk or relapsed neuroblastoma patients
where an amplification of MYCN is usually observed). SACT-1 is
designed to be used especially in combination with standard-of-care
chemotherapy. SACT-1 has been observed to be potentially applicable
to neuroblastoma and other cancers in the preclinical studies.
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), autoimmune and
infectious diseases. Aptorum has completed two phase I clinical
trials for its ALS-4 (MRSA) and orphan drug designated SACT-1
(Neuroblastoma) small molecule drugs and commercializing its NLS-2
NativusWell® nutraceutical (menopause). 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 and ongoing
clinical validation of its novel molecular-based rapid pathogen
identification and detection diagnostics technology with
Singapore’s Agency for Science, Technology and Research.
For more information about the Company, 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
US 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
investor.relations@aptorumgroup.com +44 20 80929299
Redchip – Financial Communications United States Investor
relations Craig Brelsford craig@redchip.com +1 407 571 0902
Actifin – Financial Communications Europe Investor relations
Ghislaine Gasparetto ggasparetto@actifin.fr +33 1 56 88 11 22
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