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4D-150 Shows Promise in Reducing Injection Needs for Wet AMD Patients
4D-150 significantly decreases the need for injections in wet AMD, demonstrating durability and safety in ongoing trials.
Quiver AI Overview
4D Molecular Therapeutics has shared encouraging preliminary results from its Phase 2b PRISM clinical trial for 4D-150, a potential long-lasting treatment for wet age-related macular degeneration (AMD). The trial indicated an 83% reduction in supplemental injections required compared to standard aflibercept therapy, with 70% of patients needing no additional injections and 57% remaining injection-free over a 52-week period. Among those recently diagnosed, 87% required just one or no supplementary injections, while 80% stayed injection-free. The treatment showed sustained expression of aflibercept for up to two years, accompanied by strong safety outcomes. The company plans to start further phase trials in 2025, positioning 4D-150 as a promising option for managing vascular retinal diseases and enhancing patients’ quality of life by mitigating the frequent need for injections.
Advantages of 4D-150
- 3E10 vg/eye achieved an 83% reduction in injection frequency compared to projected on-label aflibercept 2 mg Q8W, reflecting substantial improvements in treatment efficiency.
- Among recently diagnosed patients, 87% needed only one or no additional injections, and 80% remained injection-free over 52 weeks, highlighting effectiveness in this crucial group.
- The interim results point to durable, stable aflibercept expression across all PRISM cohorts, indicating potentially long-lasting effects of 4D-150.
- Follow-up reports show 4D-150 is well tolerated, with a minimal percentage experiencing any treatment-related complications, reinforcing its safety profile.
Concerns to Consider
- Increased regulatory scrutiny could arise due to potential risks, impacting 4D-150’s development timeline and market prospects.
- The company has not yet secured FDA approval for any product candidates, which may affect market confidence and financial stability.
- Setbacks in clinical trials or adverse events could alter perceptions regarding 4D-150’s safety and efficacy, potentially delaying its market introduction.
Frequently Asked Questions
What is 4D-150 designed to do?
4D-150 is engineered to provide a sustained delivery of anti-VEGF treatments aimed at managing wet AMD and diabetic macular edema (DME).
What were the Phase 2b trial results for 4D-150?
The trial demonstrated an 83% decrease in supplemental injections, with 57% of participants injection-free over the 52-week period.
How does 4D-150 enhance the treatment experience for patients?
By aiming to lower the frequency of injections, 4D-150 addresses a critical need among patients dealing with retinal diseases.
When will the next trials for 4D-150 commence?
The 4FRONT-1 trial is expected to kick off in Q1 2025, with 4FRONT-2 following in Q3 2025.
What do the safety results indicate for 4D-150?
4D-150 has shown good tolerability, with only 2.8% of patients reporting mild adverse reactions over three years of follow-up.
Disclaimer: This summary is generated by an AI from a press release shared via GlobeNewswire. The model may contain inaccuracies. Please view the full release for complete information.
Recent Insider Trading Activity for $FDMT
Over the past six months, insiders have traded $FDMT stock twice on the open market, comprising no purchases and two sales.
Details of recent insider transactions include:
- SCOTT BIZILY (Chief Legal Officer) posted 0 purchases and 2 sales, offloading 1,000 shares for an estimated $15,665.
For tracking insider transactions, refer to Quiver Quantitative’s dashboard.
Institutional Activity for $FDMT
In the latest quarter, 76 institutional investors have added shares of $FDMT to their portfolios, while 74 have reduced their holdings.
Here are some notable movements:
- BVF INC/IL acquired 3,460,229 shares (+88.2%) in Q3 2024, costing an estimated $37,405,075.
- VIKING GLOBAL INVESTORS LP divested 2,934,914 shares (-100.0%) during the same quarter, equating to about $31,726,420.
- FMR LLC dropped 1,012,123 shares (-99.6%), valued approximately at $10,941,049.
- POLAR CAPITAL HOLDINGS PLC reduced its holdings by 906,365 shares (-51.9%) in Q3 2024, worth an estimated $9,797,805.
- ASSENAGON ASSET MANAGEMENT S.A. cut back by 889,884 shares (-57.7%) in Q4 2024, amounting to around $4,956,653.
- BRAIDWELL LP increased holdings by 855,990 shares (+231.7%) in Q3 2024, totaling about $9,253,251.
- DEUTSCHE BANK AG expanded its portfolio by 678,298 shares (+545.5%) in Q3 2024, with an estimated value of $7,332,401.
To monitor hedge fund portfolios, access Quiver Quantitative’s institutional holdings dashboard.
Complete Release
- 3E10 vg/eye achieved an 83% reduction in injection burden compared to projected on-label aflibercept 2 mg Q8W; 70% required 0-1 supplemental injection, and 57% were injection-free through 52 weeks.
- In the recently diagnosed subgroup, which closely aligns with the Phase 3 4FRONT-1 and 4FRONT-2 patient demographics, 87% required 0-1 supplemental injection, while 80% stayed injection-free over 52 weeks.
- Durable and stable aflibercept expression has been demonstrated across all 3E10 vg/eye PRISM cohorts, with follow-ups extending over two years.
- 4D-150 continues to show good tolerability, supported by up to three years of follow-up data.
- 4FRONT-1 and 4FRONT-2 trials are scheduled to begin in Q1 and Q3 2025, respectively.
- The company will hold a webcast on Monday, February 10, 2025, at 8:00 a.m. ET.
EMERYVILLE, Calif., Feb. 08, 2025 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT; 4DMT or the Company), a clinical-stage company focused on optimizing genetic medicine for significant medical challenges, has announced positive initial interim data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a diverse wet age-related macular degeneration (wet AMD) patient group. Further data demonstrated the durability of aflibercept expression for up to two years. This information was shared by Dante Pieramici, M.D., during an oral presentation titled “Phase 2b Population Extension Cohort Evaluating 4D-150 in Neovascular Age-Related Macular Degeneration: 52-Week Results” at the Angiogenesis, Exudation, and Degeneration 2025 conference.
“We believe that 4D-150 has paradigm-shifting potential. It is designed to allow excellent tolerability along with robust and lasting efficacy over several years following routine intravitreal administration, facilitating seamless use in retina clinics,” commented David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
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4D-150 Shows Promise as a Transformational Therapy for Diabetic Macular Edema and Wet AMD
The latest data from the SPECTRA clinical trial highlights 4D-150’s potential to serve as the first cornerstone treatment for vascular retinal diseases. This advance addresses a major need for patients and healthcare providers by significantly alleviating the frequency of painful bolus injections.
Promising 52-Week Efficacy Results from PRISM Study (Data Cut-Off: January 15, 2025):
- Phase 2b Findings (n=30): Broad Wet AMD Disease Activity
- Supplemental Aflibercept Injections:
- 83% reduction, averaging 0.97 supplemental injections per patient over 52 weeks compared to the expected 6.0 injections with on-label aflibercept 2 mg Q8W.
- 70% of patients received 0-1 injection.
- 57% of patients were injection-free.
- Improved best corrected visual acuity (BCVA) by +2.2 letters.
- Stable central subfield thickness (CST) improvement, showing a decrease of -11 µm; -13 µm in patients without supplemental injections.
- Supplemental Aflibercept Injections:
- Phase 2b Findings (n=15): Recently Diagnosed Subgroup
- Supplemental Aflibercept Injections:
- 94% reduction, averaging 0.33 supplemental injections per patient over 52 weeks versus 6.0 with on-label aflibercept 2 mg Q8W.
- 87% received 0-1 injection.
- 80% were injection-free.
- Improved BCVA by +3.1 letters.
- Stable CST improvement, showing a decrease of -10 µm; -20 µm in patients without supplemental injections.
- Supplemental Aflibercept Injections:
Safety Update of 4D-150 from PRISM Study (Data Cut-Off: January 15, 2025):
- 4D-150 remains well-tolerated over nearly three years among patients treated with 3E10 vg/eye.
- Reported 2.8% (2 of 71) experienced 4D-150-related 1+ intraocular inflammation (IOI), noted as transient 1+ vitreous cells at one timepoint.
- 99% (70 of 71) completed steroid taper on schedule.
- 99% (70 of 71) remained entirely off steroids.
- No cases of hypotony, endophthalmitis, vasculitis, occlusive or non-occlusive retinal vasculitis, or choroidal effusions have been noted.
Dr. Dante Pieramici, a leading investigator of the PRISM study, remarked, “The potential of 4D-150 to address significant unmet needs in vascular retinal diseases cannot be overstated. It offers a long-lasting and effective treatment option that lessens the burden of frequent injections. This change could greatly improve how we manage patient care and enhance their quality of life, all while ensuring they maintain the visual benefits provided by current treatments.”
Durability Insights from All Cohorts of the PRISM Study:
- Concentrations of aqueous humor were monitored quarterly.
- Durable and stable aflibercept expression was observed, with concentrations remaining within therapeutic range for up to two years.
Future Milestones for the 4D-150 Program:
- 4FRONT-1 and 4FRONT-2 studies are set to begin in Q1 and Q3 of 2025, respectively.
- Data from the two-year Phase 1/2a and 18-month Phase 2b PRISM studies is expected in Q4 2025.
- Topline data at 52 weeks from both 4FRONT-1 and 4FRONT-2 trials is anticipated in the second half of 2027.
Corporate Webcast Information:
Title: 4D-150 in Broad Wet AMD Population: Interim 52-week Data from Phase 2b & Program Durability Update for 3E10 vg/eye (Phase 3 Dose)
Date/Time: Monday, February 10, 2025, at 8:00 a.m. ET
Registration: Link
An archived version of the webcast will be accessible for up to one year in the “Investors & Media” section of the 4DMT website: https://ir.4dmoleculartherapeutics.com/events.
Presentations from the Angiogenesis, Exudation, and Degeneration 2025 will also be found at: https://4dmoleculartherapeutics.com/pipeline/#posters-and-publications.
About 4D-150
4D-150 is a potential foundational therapy intended to offer multi-year delivery of anti-VEGF (aflibercept and anti-VEGF-C) through a single intravitreal injection. It employs the R100 intravitreal vector, developed by 4DMT’s proprietary Therapeutic Vector Evolution platform. 4D-150 targets wet AMD and diabetic macular edema, diseases affecting millions worldwide, aiming to reduce the frequency of burdensome injections while preserving vision.
About Wet AMD
Wet AMD (Age-Related Macular Degeneration) is a common condition, affecting about 200,000 newly diagnosed patients annually in the United States. According to estimates, over 4 million individuals in major markets—including the U.S., EU, and Japan—will be affected within five years. Wet AMD develops when abnormal blood vessels grow into the macula, leading to swelling, bleeding, and vision distortion. The rampant growth and leakiness of these vessels is stimulated by VEGF, posing a threat to central vision that could lead to blindness if left untreated.
About 4DMT
4DMT is a biotechnology firm focused on harnessing genetic medicine for serious diseases within ophthalmology and pulmonology. Utilizing its unique Therapeutic Vector Evolution platform, 4DMT has developed custom vectors aimed at improving treatment outcomes for patients. The lead program, 4D-150, holds significant promise in reshaping therapy approaches for eye diseases.
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4D Molecular Therapeutics Advances New Treatments for Eye Conditions and Cystic Fibrosis
Revolutionizing Retina Treatments
4D Molecular Therapeutics aims to provide a long-lasting delivery of anti-VEGF (aflibercept and anti-VEGF-C) through a single, safe injection directed at the retina. Additionally, their second key project is 4D-710. This is the first genetic medicine to show successful delivery and expression of the CFTR transgene in the lungs of cystic fibrosis (CF) patients via aerosol gene therapy. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are registered trademarks of 4DMT.
Currently, all product candidates are either in clinical or preclinical stages and have not yet received approval for marketing by the FDA or any other regulatory bodies. The safety and effectiveness of these products for their intended therapeutic uses remain unverified.
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Important Forward-Looking Statements
This press release includes forward-looking statements as outlined in the Private Securities Litigation Reform Act of 1995. These statements cover projected therapeutic and clinical benefits of 4DMT’s product candidates, particularly 4D-150, as well as anticipated clinical development plans and regulatory interactions. Words such as “may,” “will,” “expect,” “plan,” “believe,” and similar phrases typically indicate these forward-looking statements. Keep in mind that such predictions are merely expectations based on current beliefs and could differ significantly due to various risks and uncertainties featured in the “Risk Factors” section of 4D Molecular Therapeutics’ latest Quarterly Report on Form 10-Q filed on November 13, 2024, and subsequent filings with the Securities and Exchange Commission. These projections reflect the company’s views only as of the date of this release, and 4D Molecular Therapeutics disclaims any obligation to update them. No guarantees about the accuracy of these forward-looking statements are expressed or implied.
Contact Information
Media Inquiries:
Jenn Gordon
dna Communications
Media@4DMT.com
Investor Relations:
Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com
This article was originally published on Quiver News. Read the full story.
The views and opinions expressed herein are those of the author and do not necessarily represent those of Nasdaq, Inc.
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