Three In A Row: FibroGen's Investigational Drug Flunks In Another Study For Rare Disease In Young Boys
Three In A Row: FibroGen's Investigational Drug Flunks In Another Study For Rare Disease In Young Boys
Tuesday, FibroGen Inc (NASDAQ:FGEN) announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids.
星期二， FibroGen公司 納斯達克股票代碼：FGEN）公佈了pamrevlumab用於杜興氏肌營養不良症（DMD）的臥牀患者使用背景全身性皮質類固醇進行的 3 期 LELANTOS-2 試驗的頭條數據。
DMD is an inherited progressive muscular weakness disorder primarily affecting young boys.
DMD 是一種遺傳性進行性肌肉無力障礙，主要影響男孩。
The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment (NSAA) total score from baseline to week 52.
該研究未達到從基線到第52周北極星門診評估（NSAA）總分變化的主要終點。
NSAA measures functional motor abilities in ambulant children with DMD. It is usually used to monitor the progression of the disease and treatment effects.
NSAA 測量患有 DMD 的行走兒童的功能運動能力。它通常用於監測疾病進展和治療效果。
Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met.
通過與第52周基線相比在4樓梯爬坡速度、10米步行/跑步測試、站立時間、失去行走的時間以及10米步行/跑步測試中超過10秒的患者比例的變化來衡量的次要終點也未達到。
Preliminary safety data showed that pamrevlumab was generally safe and well tolerated. The majority of treatment-emergent adverse events were mild or moderate.
初步的安全數據顯示，pamrevlumab總體上是安全的，耐受性良好。大多數治療後出現的不良事件爲輕度或中度。
FibroGen is evaluating the totality of the data, including other pre-specified endpoints, to determine the next steps for the program.
FibroGen正在評估全部數據，包括其他預先指定的終點，以確定該計劃的下一步行動。
In June, FibroGen's Phase 3 LELANTOS-1 trial of pamrevlumab for non-ambulatory DMD patients with on-background corticosteroids failed to meet the primary endpoint of the Performance of the Upper Limb 2.0 score at week 52 compared to baseline.
6月，FibroGen針對背景皮質類固醇非活動性DMD患者的pamrevlumab進行的3期 LELANTOS-1 試驗與基線相比，未能達到第52週上肢表現2.0評分的主要終點。
The company's recently released topline results from its Phase 3 ZEPHYRUS-1 trial of pamrevlumab for idiopathic pulmonary fibrosis also failed to meet the primary endpoint of change in forced vital capacity at week 48.
該公司最近公佈的pamrevlumab治療特發性肺纖維化的3期 ZEPHYRUS-1 試驗的頭條結果也未能達到第48周強制性肺活量變化的主要終點。
William Blair analysts Andy Hsieh and Alexandra Ramsey say limited data support the Phase 3 LAPIS trial in locally advanced pancreatic cancer. Since a previous interim look at event-free survival prompted the trial to continue to the overall survival primary endpoint, investors do not seem bullish on the trial.
威廉布萊爾 分析師 謝安迪 亞歷山德拉·拉姆齊說，有限的數據支持LAPIS針對局部晚期胰腺癌的3期試驗。由於先前對無事件生存的中期觀察促使該試驗繼續達到總體存活率的主要終點，因此投資者似乎並不看好該試驗。
Given the LELANTOS-1 setback, the failure of LELANTOS-2 is somewhat expected, but the analysts seem to be surprised that the pamrevlumab arm performed numerically worse than the placebo arm.
鑑於 LELANTOS-1 的挫折，LELANTOS-2 的失敗在某種程度上是可以預料的，但分析師似乎感到驚訝的是，pamrevlumab組的表現比安慰劑組差得多。
Other pipeline assets are too early to assess their commercial prospects properly.
其他管道資產還爲時過早，無法正確評估其商業前景。
Price Action: FGEN shares are down 22.3% at $1.00 during the premarket session on the last check Wednesday.
價格走勢: FGEN股價在週三最後一次支票的盤前交易時段下跌22.3％，至1.00美元。