EMERYVILLE, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced that enrollment has been completed in all 3 cohorts of the Phase 1 Dose Exploration stage of the Phase 1/2 clinical trial of intravitreal 4D-150 in patients with wet AMD (n=15 patients total; 5 patients per cohort). All 3 cohorts have been cleared for safety, with no dose-limiting toxicities (DLTs) being reported.
4D Molecular Therapeutics also announced that interim clinical data from cohort 1 of this Phase 1/2 clinical trial will be released at 7:30 am E.T., on Monday, November 14, 2022. 4D will host a conference call and live webcast on November 14th, 2022, at 8:00 am E.T. to further discuss the interim clinical data.
The presentation will include a summary of the following in patients with wet AMD who have been enrolled and treated with 4D-150 in cohort 1 of the Dose Exploration stage of the clinical trial (n=5; 3E10 vg/eye):
- Safety and tolerability data
- Aflibercept transgene expression in aqueous humor samples
- Efficacy assessments as follows: change in annualized anti-VEGF injection rate after 4D-150 dosing, and
- Percent of patients who remain supplemental aflibercept injection-free after 4D-150 dosing.
Conference Call Information
4D Molecular Therapeutics will host a conference call and live webcast on November 14, 2022, at 8:00 am E.T. to discuss the interim clinical data.
Registration and dial-in for the conference call may be accessed through 4D Molecular Therapeutics website under Events & Presentation in the Investors section through the following link: https://ir.4dmoleculartherapeutics.com/events. An archived replay of the webcast will be available following the event.
About 4D-150 and wet AMD
4D-150 is comprised of our targeted and evolved intravitreal vector, R100, and a payload that expresses aflibercept and a VEGF-C RNAi. This dual transgene payload inhibits 4 angiogenic factors: VEGF A, B, C and PlGF. 4D-150 is designed for low dose intravitreal delivery.
Wet AMD is a type of macular degeneration where abnormal blood vessels (choroidal neovascularization or CNV) grow into the macula, the central area of the retina. As a consequence, CNV causes swelling and edema of the retina, bleeding and scarring, and causes visual distortion and reduced 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.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. 4DMT seeks to unlock the full potential of genetic medicines using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent targeted and evolved vectors for use in our products. The company is initially focused on five clinical-stage products in three therapeutic areas for both rare and large market diseases: ophthalmology, cardiology (including Fabry disease) and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered at relatively low doses through clinically routine, well tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. The five 4DMT product candidates in clinical development are: 4D-150 for wet AMD, 4D-310 for Fabry disease, 4D-710 for cystic fibrosis, 4D-125 for XLRP, and 4D-110 for choroideremia.
4D-150, 4D-310, 4D-710, 4D-125, and 4D-110 are in clinical trials and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-310, 4D-710, 4D-125, and 4D-110 for the therapeutic use for which they are being studied. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.
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, as well as the plans for the clinical development of 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.
August J. Moretti