- Nanomolar Antiviral Potency of ADX-1612 Against SARS-CoV-2
Confirmed in Preclinical Studies
- Novel Anti-Inflammatory Activity of ADX-1612 Demonstrated in
SARS-CoV-2-Infected Human Cells
- International Collaboration Established with the Laboratory of
Dr. Markus Landthaler at the Max Delbrück Center for Molecular
Medicine in Berlin, Germany for Assessment of ADX-1612 in Cell and
Animal COVID-19 Models
- Additional Third-Party Publications of ADX-1612 Activity in
COVID-19-Related Experiments Released
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced confirmation of SARS-CoV-2 antiviral activity of
ADX-1612, in addition to novel anti-inflammatory activity in
SARS-CoV-2-infected primary human cells in preclinical studies. The
results are derived from an international collaboration with the
Max Delbrück Center for Molecular Medicine in the Helmholtz
Association (MDC) in Berlin, Germany, which plans additional
studies with colleagues at the Charité – Universitätsmedizin Berlin
University Hospital in cell and animal COVID-19 models.
“The antiviral and anti-inflammatory activity of ADX-1612
demonstrated in COVID-19 models may be applicable to viral diseases
generally,” stated Emanuel Wyler, Ph.D., Research Scientist at
MDC.
“We look forward to continuing our collaboration with Aldeyra as
we advance ADX-1612 to additional cell and animal models to further
characterize the activity of ADX-1612 in COVID-19 and other viral
infections,” added Markus Landthaler, Ph.D., Group Leader of the
Coronavirus Task Force and the Laboratory for RNA Biology and
Post-transcriptional Regulation at MDC.
In May 2020, Dr. Wyler and colleagues identified HSP90 as a key
antiviral target against SARS-CoV-21 and have confirmed the
antiviral activity of ADX-1612, a potent HSP90 inhibitor, reported
by Aldeyra earlier this year. Additional reports of the activity of
ADX-1612, also known as ganetespib, and other HSP90 inhibitors have
been subsequently published by independent laboratories.2
The anti-inflammatory activity of ADX-1612, as assessed by
cytokine transcription in SARS-CoV-2-infected primary human cells,
included down-regulation of TNF-α, IFN-1β, IL-6, and a variety of
other cytokines and pro-inflammatory mediators.
“We are thrilled to work with the MDC as we continue to
characterize the activity of ADX-1612 as a potential antiviral and
immune-modulating approach for the treatment of serious viral
infections,” stated Todd C. Brady, M.D., Ph.D., President and Chief
Executive Officer of Aldeyra.
About ADX-1612
ADX-1612, which has been clinically tested in more than 1,600
subjects for the potential treatment of cancer, is an inhibitor of
chaperone protein HSP90, a target widely implicated in viral
disease.3 Complementary to the nucleic acid inhibition mechanism of
action of remdesivir and related antiviral compounds, ADX-1612
potentially leads to the inhibition of proteins associated with
viral replication and infection, and thereby may enhance the
activity of other antiviral drugs for the treatment of COVID-19 and
other viral infections. Importantly, via comprehensive expression
profiling of human cell lines infected with SARS-CoV-2, HSP90 was
identified as a key pharmaceutical target for viral inhibition.1
More recently, the anti-inflammatory activity of ADX-1612 has been
demonstrated in SARS-CoV-2-infected human cells.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target RASP
(reactive aldehyde species), which are elevated in ocular and
systemic inflammatory disease and result in cytokine release via
activation of a broad array of inflammatory factors, including
NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being
evaluated in Phase 3 clinical trials in patients with dry eye
disease and allergic conjunctivitis. The company’s clinical
pipeline also includes ADX-2191, a dihydrofolate reductase
inhibitor in Phase 3 testing for proliferative vitreoretinopathy,
and ADX-1612, a chaperome inhibitor in development for COVID-19 and
ovarian cancer. For more information, visit
https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and
Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding the antiviral and anti-inflammatory
activity of ADX-1612 and plans for additional preclinical testing.
Aldeyra intends such forward-looking statements to be covered by
the safe harbor provisions for forward-looking statements contained
in Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995. In some cases,
you can identify forward-looking statements by terms such as, but
not limited to, "may," "might," "will," "objective," "intend,"
"should," "could," "can," "would," "expect," "believe,"
"anticipate," "project," "on track," "scheduled," "target,"
"design," "estimate," "predict," "potential," "aim," "plan" or the
negative of these terms, and similar expressions intended to
identify forward-looking statements. Such forward-looking
statements are based upon current expectations that involve risks,
changes in circumstances, assumptions, and uncertainties. Aldeyra
is at an early stage of development and may not ever have any
products that generate significant revenue. All of Aldeyra's
development timelines may be subject to adjustment depending on
recruitment rate, regulatory review, preclinical and clinical
results, and other factors that could delay the initiation or
completion of clinical trials. Important factors that could cause
actual results to differ materially from those reflected in
Aldeyra's forward-looking statements include, among others, the
timing of enrollment, commencement and completion of Aldeyra's
clinical trials, the timing and success of preclinical studies and
clinical trials conducted by Aldeyra and its development partners;
updated or refined data based on Aldeyra's continuing review and
quality control analysis of clinical data, Aldeyra's ability to
design clinical trials with protocols and endpoints acceptable to
applicable regulatory authorities; delay in or failure to obtain
regulatory approval of Aldeyra's product candidates; the ability to
maintain regulatory approval of Aldeyra's product candidates, and
the labeling for any approved products; the risk that prior
results, such as signals of safety, activity or durability of
effect, observed from preclinical or clinical trials, will not be
replicated or will not continue in ongoing or future studies or
clinical trials involving Aldeyra's product candidates; the scope,
progress, expansion, and costs of developing and commercializing
Aldeyra's product candidates; uncertainty as to Aldeyra’s ability
to commercialize (alone or with others) Aldeyra's product
candidates following regulatory approval, if any; the size and
growth of the potential markets and pricing for Aldeyra's product
candidates and the ability to serve those markets; Aldeyra's
expectations regarding Aldeyra's expenses and revenue, the
sufficiency or use of Aldeyra's cash resources and needs for
additional financing; political, economic, legal, social and health
risks, including the recent COVID-19 outbreak and subsequent public
health measures, that may affect Aldeyra’s business or the global
economy; the rate and degree of market acceptance of any of
Aldeyra's product candidates; Aldeyra's expectations regarding
competition; Aldeyra's anticipated growth strategies; Aldeyra's
ability to attract or retain key personnel; Aldeyra’s limited sales
and marketing infrastructure; Aldeyra's ability to establish and
maintain development partnerships; Aldeyra’s ability to
successfully integrate acquisitions into its business; Aldeyra's
expectations regarding federal, state and foreign regulatory
requirements; regulatory developments in the United States and
foreign countries; Aldeyra's ability to obtain and maintain
intellectual property protection for its product candidates; the
anticipated trends and challenges in Aldeyra's business and the
market in which it operates; and other factors that are described
in the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
Aldeyra's Annual Report on Form 10-K for the year ended December
31, 2019 and Aldeyra's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at https://www.sec.gov/.
In addition to the risks described above and in Aldeyra's other
filings with the SEC, other unknown or unpredictable factors also
could affect Aldeyra's results. No forward-looking statements can
be guaranteed and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Aldeyra undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
1 Bulk and single-cell gene expression profiling of SARS-CoV-2
infected human cell lines identifies molecular targets for
therapeutic intervention. BioRxiv, 2020,
https://doi.org/10.1101/2020.05.05.079194. 2 Global analysis of
protein-RNA interactions in SARS-CoV-2 infected cells reveals key
regulators of infection, https://doi.org/10.1101/2020.11.25.398008;
SARS-CoV-2 infection remodels the host protein thermal stability
landscape, https://doi.org/10.21203/rs.3.rs-105193/v1. 3 HSP90: a
promising broad-spectrum antiviral drug target. Arch Virol. 2017;
162(11): 3269‐3282, https://doi.org/10.1007/s00705-017-3511-1;
Could targeting the heat shock protein 90 revolutionize antiviral
therapy? Future Virology 2018; 13(2): 119-127,
https://doi.org/10.2217/fvl-2017-0111.
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version on businesswire.com: https://www.businesswire.com/news/home/20201222005310/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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