4DMT to Present Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis at 47ᵗʰ European Cystic Fibrosis Conference
May 30 2024 - 8:00AM
4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company),
a leading clinical-stage genetic medicines company focused on
unlocking the full potential of genetic medicines to treat large
market diseases, today announced that interim data from the Phase
1/2 AEROW clinical trial evaluating aerosolized 4D-710 for
treatment of cystic fibrosis lung disease will be presented at the
47th European Cystic Fibrosis Conference, taking place in Glasgow,
UK. The Company will host a webcast to discuss the data in detail
and provide a program update on Thursday, June 6 at 8:00 a.m. ET.
47th European Cystic
Fibrosis Conference Presentation Details:
Title: |
CFTR transgene expression in airway epithelial cells following
aerosolized administration of the AAV-based gene therapy 4D-710 to
adults with cystic fibrosis lung disease |
Session: |
WS06 – Where are we with new
therapeutic approaches? |
Date/Time: |
Thursday, June 6, 2024 (5:00 to
5:15 p.m. BST) |
Presenter: |
Jennifer L. Taylor-Cousar, M.D.,
National Jewish Health |
|
|
The presentation from the 47th European Cystic Fibrosis
Conference will also be available on the 4DMT website:
https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications
Corporate Webcast Details:
Title: |
4D-710 Phase 1/2 AEROW Interim Clinical Data & Program
Update |
Date/Time: |
Thursday, June 6, 2024 at 8:00
a.m. ET |
Registration: |
Link |
|
|
An archived copy of the webcast will be available for up to one
year by visiting the “Investors & Media” section of the 4DMT
website at the following link:
https://ir.4dmoleculartherapeutics.com/events.
About Cystic Fibrosis Lung Disease
Cystic fibrosis (CF) is an inherited progressive disease caused
by mutations in the CFTR gene. It affects the lungs, pancreas and
other organs. According to the Cystic Fibrosis Foundation, nearly
40,000 people in the United States and more than 105,000 people
worldwide are living with CF, with approximately 1,000 new cases of
CF diagnosed in the United States each year. Lung disease is the
leading cause of morbidity and mortality in people with CF. CF
causes impaired lung function, inflammation and bronchiectasis and
is commonly associated with persistent lung infections and repeated
exacerbations due to the inability to clear thickened mucus from
the lungs. People with CF require lifelong treatment with multiple
daily medications. The complications of the disease result in
progressive loss of lung function, increasing need for IV
antibiotics and hospitalizations, and ultimately lead to end-stage
respiratory failure.
About 4D-710
4D-710 is comprised of our targeted and evolved next generation
AAV vector, A101, and a codon-optimized CFTR∆R transgene. 4D-710
has the potential to treat a broad range of people with CF,
independent of the specific CFTR mutation, and is designed for
aerosol delivery to achieve targeted CFTR expression within lung
airway epithelial cells. 4D-710 is being initially developed for
the approximately 15% of people with CF whose disease is not
amenable to existing CFTR modulator medicines (based on
variant-eligibility and/or drug intolerance). In people with CFTR
variants that are amenable to modulator medicines, the improvement
in lung function is variable and often incomplete. We therefore
expect to potentially develop 4D-710 for use in this broader
population, either as a single agent and/or in combination with
CFTR modulator medicines. 4D-710 has received the Rare Pediatric
Disease Designation and Orphan Drug Designation from the U.S. Food
and Drug Administration (FDA).
About 4DMT
4DMT is a leading clinical-stage genetic medicines company
focused on unlocking the full potential of genetic medicines to
treat large market diseases in ophthalmology and pulmonology.
4DMT’s proprietary invention platform, Therapeutic Vector
Evolution, combines the power of the Nobel Prize-winning
technology, directed evolution, with approximately one billion
synthetic AAV capsid-derived sequences to invent customized and
evolved vectors for use in our wholly owned and partnered product
candidates. Our product design, development, and manufacturing
engine help us efficiently create and advance our diverse product
pipeline with the goal of revolutionizing medicine with potential
curative therapies for millions of patients. Currently, 4DMT is
advancing five clinical-stage and two preclinical product
candidates, each tailored to address rare and large market diseases
in ophthalmology, pulmonology and cardiology. In addition, 4DMT is
also advancing programs in CNS through a gene editing partnership.
4D Molecular Therapeutics™, 4DMT®, 4D®, Therapeutic Vector
Evolution™, and the 4DMT logo are trademarks of 4DMT.
All of our product candidates are in clinical or preclinical
development and have not yet been approved for marketing by the FDA
or any other regulatory authority. No representation is made as to
the safety or effectiveness of our product candidates for the
therapeutic uses for which they are being studied.
Learn more at www.4DMT.com and follow us on LinkedIn.
Forward-Looking Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding the therapeutic potential, and
clinical benefits of 4DMT’s product candidates, as well as the
plans, announcements and related timing for the clinical
development of 4D-710. The words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “expect,” “estimate,” “seek,” “predict,” “future,”
“project,” “potential,” “continue,” “target” and similar words or
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including risks and
uncertainties that are described in greater detail in the section
entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent
Quarterly Report on Form 10-Q as well as any subsequent filings
with the Securities and Exchange Commission. In addition, any
forward-looking statements represent 4D Molecular Therapeutics’
views only as of today and should not be relied upon as
representing its views as of any subsequent date. 4D Molecular
Therapeutics explicitly disclaims any obligation to update any
forward-looking statements. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
Contacts:
Media:
Katherine SmithInizio Evoke
CommsKatherine.Smith@inizioevoke.com
Investors:
Julian PeiHead of Investor Relations and Corporate
FinanceInvestor.Relations@4DMT.com
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