4DMT Presents Injection-Free Subgroup Analyses from 4D-150 Phase 2 PRISM Randomized Dose Expansion Cohort in Wet AMD Patients with Severe Disease Activity & High Treatment Burden at the Clinical Trials at the Summit 2024 Meeting
2024年6月9日 - 5:30AM
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 presented supplemental aflibercept
injection-free subgroup analyses of the previously reported 24-week
landmark results from the randomized Dose Expansion cohort from the
Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet
age-related macular degeneration (wet AMD) patients with severe
disease activity and a high treatment burden. The data were
presented today at Clinical Trials at the Summit 2024 in Park City,
Utah, by Carl Danzig, M.D., Rand Eye Institute, Deerfield Beach,
Florida.
“The injection-free subgroup analyses demonstrate the potential
for a single intravitreal 3E10 vg dose of 4D-150 to improve and
stabilize retinal anatomy while improving or stabilizing vision in
the most severe form of wet AMD with the highest VEGF treatment
burden, without the need for any supplemental treatment through 24
weeks in the majority of patients treated,” said Robert Kim, M.D.,
Chief Medical Officer of 4DMT. “4D-150 to date has shown robust
clinical activity with a favorable safety profile, and the data
provide additional evidence that 4D-150 has the potential to treat
all patients suffering from wet AMD. We look forward to sharing
interim results from the Population Extension cohort of PRISM at
ASRS in July 2024, and an update on our Phase 3 clinical trial
design in the third quarter of 2024.”
Phase 2 PRISM Supplemental Injection-Free Subgroup
Analyses
- Stable visual acuity observed
through Week 24 in both 4D-150 dose groups (n=22 injection-free
patients); BCVA equal to or numerically higher than bimonthly
aflibercept (n=10 patients) at all six time points through Week
24
- High dose (3E10 vg/eye; n=12
patients):
- Sustained reduction and
stabilization of CST fluctuations compared to bimonthly aflibercept
at all six timepoints through Week 24
- The average mean change from
baseline in CST at Weeks 20 and 24 was -52.2 mm in the 3E10
vg/eye group and -21.4 in the aflibercept group (mean difference,
-30.8 mm)
For additional details, click here to view the
scientific presentation, which is available on the 4DMT
website: https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications
Upcoming 4D-150 Milestones
- Phase 2 PRISM Population Extension
cohort (N=32) in the broader wet AMD patient population:
- Initial interim 24-week landmark
analysis expected to be presented at the ASRS Annual Scientific
Meeting on July 17, 2024
- Phase 3 planning:
- Update on Phase 3 clinical trial
design expected in Q3 2024
- First Phase 3 clinical trial
initiation expected in Q1 2025
About Wet AMD
Wet AMD is a highly prevalent disease with estimated incidence
rate of 200,000 new patients per year in the United States. It is
estimated that the total prevalence of wet AMD in certain major
markets, including the United States and the European Union (major
markets), and Japan, will be greater than 4 million individuals in
the next five years. Wet AMD is a type of macular degeneration
where abnormal blood vessels (macular neovascularization or MNV)
grow into the macula, the central area of the retina. As a
consequence, MNV causes swelling and edema of the retina, bleeding
and scarring, and causes visual distortion and reduced visual
acuity. The proliferation and leakage of abnormal blood vessels is
stimulated by VEGF. This process distorts and can potentially
destroy central vision and may progress to blindness without
treatment.
About 4D-150 for Wet AMD
4D-150 combines our customized and evolved intravitreal vector,
R100, and a transgene cassette that expresses both aflibercept and
a VEGF-C inhibitory RNAi. This dual-transgene payload inhibits four
members of the VEGF angiogenic family of factors that drive wet AMD
and DME: VEGF A, B, C and PlGF. R100 was invented at 4DMT through
our proprietary Therapeutic Vector Evolution platform; we developed
this platform utilizing principles of directed evolution, a Nobel
Prize-winning technology. 4D-150 is designed for single, low-dose
intravitreal delivery for transgene expression from the retina
without significant inflammation.
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 helps 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™, 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
U.S. Food and Drug Administration (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 and regulatory interactions regarding 4D-150. 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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