4D Molecular Therapeutics Stock Falls After Follow-Up Data From Mid-Stage Study Of Vision Loss Drug Candidate
4D Molecular Therapeutics Stock Falls After Follow-Up Data From Mid-Stage Study Of Vision Loss Drug Candidate
In Phase 2b, recently diagnosed patients, a 98% overall reduction in annualized injections, 100% received 0 or 1 injection, and 87% injection-free was observed.4D Molecular Therapeutics (NASDAQ:FDMT) stock is trading lower on Thursday after the company released interim follow-up data from the Phase 1/2 PRISM clinical trial and 4FRONT Phase 3 study design.
4d分子治療（納斯達克:FDMT）股票週四交易走低，此前公司發佈了第1/2期PRISm臨床試驗和4FRONt第3期研究設計的中期追蹤數據。
Robust and durable treatment burden reduction was observed in all PRISM populations studied with the planned Phase 3 dose of 3E10 vg/eye of 4D-150.
觀察到在所有PRISm人群中，使用計劃的納斯達克第3階段劑量3E10 vg/eye的4d molecular therapeutics，治療負擔減輕強健耐用。
83% overall reduction in annualized injections, 52% received 0 or 1 injection, and 44% injection-free in Phase 1/2a Severe study compared to Phase 2b Broad study with observations of 89%, 80%, and 70% injection-free, respectively.
與第20億階段廣泛研究的觀察相比，在第1/2a嚴重研究中，年化注射整體減少了83%，52%的人接受了0或1次注射，44%的人不需要注射，而在第20億階段，相應觀察到了89%、80%和70%的不需要注射。
In Phase 2b, recently diagnosed patients, a 98% overall reduction in annualized injections, 100% received 0 or 1 injection, and 87% injection-free was observed.
在第20億階段，最近確診的患者中，年化注射整體減少了98%，100%的人接受了0或1次注射，87%的人無需注射。
In June, 4D Molecular Therapeutics unveiled interim 24-week data from the Population Extension cohort of its PRISM Phase 2 Clinical Trial.
在6月，納斯達克第2階段臨床試驗的人群延伸隊列公佈了24周的臨時數據。
The trial evaluates intravitreal 4D-150 in a broad wet AMD patient population.
該試驗評估了廣泛的溼性AMD患者人群內視網膜內注射的4d molecular therapeutics。
Central Subfield Thickness (CST): sustained anatomic control with fewer fluctuations.
中央視野厚度（CST）：保持解剖上控制，並減少波動。
4D-150 continues to be well tolerated with a favorable safety profile
4d molecular therapeutics繼續被很好地耐受，並且具有良好的安全性。
The rate of 4D-150 intraocular inflammation (IOI) is numerically similar to that reported for approved anti-VEGF agents.
4D-150眼內炎（IOI）的發病率與已批准的抗VEGF藥物報告的數字類似。
- Wet AMD:2.8% (2 of 71) had 4D-150–related IOI at any time point, and two patients had transient 1+ vitreous cells
- 99% (70 of 71) completed steroid prophylaxis taper on schedule and 97% (69 of 71) remained off steroids completely.
- Diabetic Macular Edema (DME; SPECTRA trial): No patients treated at any dose (n=22) have experienced IOI events at any time.
- 溼性黃斑變性：2.8%（71中的2名患者）在任何時間點上與4D-150相關的IOI，並且有兩名患者出現短暫的1+玻璃體細胞。
- 99%（71中的70名患者）按計劃完成類固醇預防性緩解，並且有97%（71中的69名患者）完全停用類固醇。
- 糖尿病性黃斑水腫（DME；SPECTRA試驗）：任何劑量（n=22）的患者在任何時間點都未發生IOI事件。
In February this year, 4D Molecular Therapeutics released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients.
今年2月，4d molecular therapeutics發佈了來自PRISm第2期臨床試驗的中期數據，評估溼性老年性黃斑變性（溼性AMD）患者的眼內注射4D-150。
The company plans for a global 4FRONT Phase 3 development program comparing a single dose of 4D-150 3E10 vg/eye to on-label Regeneron Pharmaceuticals Inc.'s (NASDAQ: REGNP Eylea (aflibercept) 2mg Q8 weeks. The trial is expected to start in the first quarter of 2025, with around 500 participants.
該公司計劃開展全球4FRONt第3期開發計劃，比較單次劑量的4D-150 3E10 vg/eye與Regeneron Pharmaceuticals Inc.（NASDAQ：REGNP）的（aflibercept）2mg Q8周的標準使用劑量。該試驗預計於2025年第一季度開始，參與者約有500人。
Price Action: FDMT stock is down 18.80% at $13.66 at the last check on Thursday.
股價走勢：FDMt股票在最後一次檢查時下跌了18.80%，爲13.66美元。
- Hims & Hers To Offer Access To Compounded Diabetes And Weight Loss Drugs For Just $99/Month To Certain Professional Personnel.
- Hims & Hers將爲特定專業人員提供合成的糖尿病和減肥藥物訪問權限，每月僅需99美元。
譯文內容由第三人軟體翻譯。