Ascendis Pharma Presents New InsiGHTS Trial Of TransCon HGH In Turner Syndrome Achieved Primary Objective At Week 26; Results For All Three TransCon HGH Starting Dose Cohorts, In First Clinical Trial Of An Indication Outside Of Growth Hormone...
Ascendis Pharma Presents New InsiGHTS Trial Of TransCon HGH In Turner Syndrome Achieved Primary Objective At Week 26; Results For All Three TransCon HGH Starting Dose Cohorts, In First Clinical Trial Of An Indication Outside Of Growth Hormone...
New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into one of four treatment groups 1:1:1:1 – one of three starting doses of TransCon hGH (0.24, 0.30, or 0.36 mg/kg/week) or an active comparator of daily somatropin with a starting dose of 0.35 mg/kg/week. Doses were individualized based on IGF-1.Ascendis Pharma Presents New InsiGHTS Trial Of TransCon HGH In Turner Syndrome Achieved Primary Objective At Week 26; Results For All Three TransCon HGH Starting Dose Cohorts, In First Clinical Trial Of An Indication Outside Of Growth Hormone Deficiency, Showed A Safety And Tolerability Profile Comparable To Daily Somatropin
Ascendis Pharma 發佈的新InsiGHTS試驗結果顯示，TransCon HGH在特納綜合症中在第26周達到了主要目標；三種TransCon HGH起始劑量組的結果，顯示出與每日重組生長激素相當的安全性和耐受性概況，這是針對生長激素缺乏症以外適應症的首次臨床試驗。
- Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin
- 三種TransCon HGH起始劑量組的結果顯示出與每日重組生長激素相當的安全性和耐受性概況，這是針對生長激素缺乏症以外適應症的首次臨床試驗。
- Annualized height velocity was similar at Week 26 in once-weekly TransCon hGH-treated and daily somatropin-treated children
- 第26周，在每週一次的TransCon HGH治療組和每日重組生長激素治療組兒童中的年化生長速度相似。
COPENHAGEN, Denmark, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced positive Week 26 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. to investigate the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; approved for pediatric growth hormone deficiency) compared to daily somatropin in prepubertal children with Turner syndrome.
丹麥哥本哈根，2024年12月16日（環球新聞）-- Ascendis Pharma A/S（納斯達克：ASND）今天宣佈其美國進行的Phase 2隨機、開放標籤、活性對照試驗New InsiGHTS在第26周取得積極的頂線結果，該試驗旨在研究每週一次的TransCon HGH（lonapegsomatropin；已批准用於兒童生長激素缺乏症）與每日重組生長激素在特納綜合症前青春期兒童中的安全性、耐受性和療效。
New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into one of four treatment groups 1:1:1:1 – one of three starting doses of TransCon hGH (0.24, 0.30, or 0.36 mg/kg/week) or an active comparator of daily somatropin with a starting dose of 0.35 mg/kg/week. Doses were individualized based on IGF-1.
新InsiGHTS對49名年齡在1到10歲特納綜合症兒童進行了隨機分組和劑量調整，分爲四個治療組1:1:1:1——三種TransCon HGH起始劑量（0.24、0.30或0.36 mg/kg/周）或每日重組生長激素的活性對照，起始劑量爲0.35 mg/kg/周。劑量根據IGF-1進行個體化調整。
- On the primary endpoint of annualized height velocity and secondary endpoint of change from baseline in height SDS, children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose.
- In the trial, TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily somatropin.
- 在年化生長速度的主要終點和基線身高標準差分數變化的次要終點上，接受TransCon HGH治療的兒童在第26周的生長改善情況與每日重組生長激素相似，與起始劑量無關。
- 在試驗中，TransCon HGH總體上是安全且耐受良好的，沒有因試驗藥物而中斷，並且安全性和耐受性與每日重組生長激素相當。
譯文內容由第三人軟體翻譯。
