Wet AMD is a highly prevalent disease with an estimated incidence rate of 200,000 new patients per year in the United States, according to published data. 4D-150 is designed for a single low dose intravitreal delivery. This dual transgene payload inhibits 4 angiogenic factors: VEGF A, B, C and PlGF. R100 was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform we created this platform utilizing principles of directed evolution, a Nobel Prize-winning technology. “We are excited to have started enrolling the Phase 2 portion of our PRISM trial in wet AMD, and to evaluate the potential of 4D-150 in patients with DME who also require frequent anti-VEGF injections and have a high treatment burden.”ĤD-150 is comprised of our targeted and evolved intravitreal vector, R100, and a payload that expresses both aflibercept and a VEGF-C RNAi. The robustness and efficiency of our product design and development engine are based on sustained excellence by our manufacturing, preclinical, clinical, and regulatory teams,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This is the sixth US IND submitted by 4DMT, and all six have been cleared by the FDA. In addition, the Company intends to present interim data for dose Cohorts 1, 2, & 3 (n=15) at the 2023 ARVO Annual Meeting taking place April 23-27, 2023 at the time of the ARVO data presentation, all patients are predicted to have at least six months of follow-up following 4D-150 treatment. This portion of the trial is now enrolling patients. On January 9, 2023, 4DMT disclosed that the Company had initiated the randomized Phase 2 portion of the Phase 1/2 PRISM clinical trial for 4D-150 in patients with wet AMD. Initial Cohort 1 data (n=5) from the Phase 1 portion of the Phase 1/2 PRISM clinical trial with 4D-150 for wet age-related macular degeneration (wet AMD) demonstrated a reduction in annualized anti-VEGF injection rate by over 95%, further validating the potential of our intravitreal R100 vector for other large market eye diseases such as geographic atrophy. The IND clearance enables the initiation of SPECTRA clinical study sites, and 4DMT expects to begin enrollment in the third quarter of 2023. The doses to be evaluated in DME are anticipated to be between 6E9 to 3E10 vg/eye. The study design consists of a Dose Confirmation stage followed by a masked Dose Expansion stage, in which patients will be randomized to receive a single intravitreal injection at one of two dose levels of 4D-150 or aflibercept in a 1:1:1 ratio (n=54 patients). The Phase 2 SPECTRA clinical trial will assess 4D-150 in patients with DME. 02, 2023 (GLOBE NEWSWIRE) - 4D Molecular Therapeutics (Nasdaq: FDMT, “4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced FDA clearance of the Investigational New Drug Application (IND) for 4D-150, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with Diabetic Macular Edema (DME). Randomized Phase 2 portion of the Phase 1/2 PRISM clinical trial with 4D-150 for wet AMD is currently enrollingĮMERYVILLE, Calif., Feb. Interim PRISM data for dose Cohorts 1, 2, & 3 (n=15) to be presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting Initial Phase 1 PRISM clinical trial with 4D-150 for wet age-related macular degeneration further validates R100 intravitreal vector potential for other large market eye diseases including geographic atrophy 4D-110 is used for the treatment of choroideremia.4D-150 Phase 2 SPECTRA clinical trial for diabetic macular edema enrollment is expected to initiate in Q3 2023 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP). 4D-310 is used for the treatment of Fabry disease cardiomyopathy. 4D-710 is used for the treatment of cystic fibrosis lung disease (both in modulator ineligible and eligible populations). 4D-150 is used for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The Company's initial product candidates are focused on therapeutic areas, such as ophthalmology, pulmonology, and cardiology. The Company is developing a diverse pipeline of product candidates for both large market and rare diseases, including patient populations that other genetic medicines are unable to address. is a clinical-stage biotherapeutics company.
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