Marinus Pharmaceuticals' Oral Seizure Drug Disappoints In Late-Stage Study, Appoints Advisor To Explore Options
Marinus Pharmaceuticals' Oral Seizure Drug Disappoints In Late-Stage Study, Appoints Advisor To Explore Options
"As the first controlled trial in TSC that allowed enrollment of patients taking a range of concomitant antiseizure medications, which included mTOR inhibitors and cannabidiol, these data represent a significant advancement in our understanding of the use of ganaxolone with other standard of care treatments," said Scott Braunstein, Chairman and CEO of Marinus. "We are disappointed that the results of the TrustTSC trial are not likely to be sufficient for an sNDA filing."On Thursday, Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) stock plunged after the company revealed disappointing data from the Phase 3 TrustTSC trial of oral ganaxolone for seizures associated with tuberous sclerosis complex (TSC) in children and adults.
週四，marinus pharmaceuticals股票(NASDAQ:MRNS)暴跌，因公司公佈了口服甘奈酮在管鞘硬化症(TSC)患兒和成人癲癇試驗階段3 TrustTSC的令人失望的數據。
TSC is a rare genetic condition that mainly causes non-cancerous (benign) tumors to develop in different body parts.
TSC是一種罕見的遺傳疾病，主要導致不同部位出現非癌性(良性)腫瘤。
Also Read: Marinus Pharmaceuticals Shares Mixed Results From IV Formulated Ganaxolone In Pretreated Seizure Patients.
此外閱讀: 出售預處理癲癇患者的IV製劑甘奈酮的marinus pharmaceuticals股票獲得了不同的結果。
"As the first controlled trial in TSC that allowed enrollment of patients taking a range of concomitant antiseizure medications, which included mTOR inhibitors and cannabidiol, these data represent a significant advancement in our understanding of the use of ganaxolone with other standard of care treatments," said Scott Braunstein, Chairman and CEO of Marinus. "We are disappointed that the results of the TrustTSC trial are not likely to be sufficient for an sNDA filing."
「作爲TSC中第一個允許參與正在服用一系列抗癲癇藥物的患者的受控試驗，其中包括mTOR抑制劑和大麻二酚，這些數據代表了我們對甘奈酮與其他標準治療方法聯合應用的理解方面的顯著進展，」 marinus的董事會主席兼首席執行官斯科特·布勞斯坦說。「我們很失望TrustTSC試驗的結果可能不足以支持提交sNDA申請。」
The 129-subject trial did not meet the primary endpoint of percent change in 28-day TSC-associated seizure frequency. Median reduction was 19.7% for ganaxolone compared with 10.2% for placebo (p=0.09).
這項涉及129名對象的試驗未滿足28天TSC相關癲癇發作百分比變化的主要終點。甘奈酮的中位數減少爲19.7%，而安慰劑爲10.2% (p=0.09)。
While reductions in seizure frequency favored the ganaxolone arm, the primary endpoint did not achieve statistical significance.
儘管癲癇發作次數減少有利於甘奈酮組，但主要終點未達到統計學顯著性。
Ganaxolone was generally well-tolerated with a safety profile consistent with previous clinical trials.
甘油酮通常耐受良好，安全性與先前臨床試驗一致。
The most frequent adverse event was somnolence: 28.1% for ganaxolone compared with 16.9% for placebo.
最常見的不良事件是嗜睡：甘奈酮組爲28.1%，安慰劑組爲16.9%。
Marinus will continue to support and invest in the commercial growth of Ztalmy (ganaxolone) oral suspension CV, which is FDA-approved for seizures associated with CDKL5 deficiency disorder in patients two years and older.
marinus pharmaceuticals將繼續支持並投資於Ztalmy（ganaxolone）口服懸浮液CV的商業增長，該藥已獲FDA批准，用於兩歲及以上患者的CDKL5缺陷症引發的癲癇。
As a result of the TrustTSC outcome, Marinus is discontinuing further ganaxolone clinical development and taking additional steps to reduce costs, including reducing its workforce.
由於TrustTSC的結果，marinus pharmaceuticals正在終止進一步的ganaxolone臨床開發，並採取額外措施以降低成本，包括削減其員工。
The company has also commenced a process to explore strategic alternatives and has engaged Barclays as an advisor to assist in reviewing its strategic alternatives.
該公司還已啓動了探索戰略替代方案的流程，並聘請巴克萊銀行作爲顧問，協助審查其戰略替代方案。
Price Action: MRNS stock is down 82.80% at $0.29 at the last check Thursday.
股價表現：MRNS股價在週四最後一次檢查時下跌了82.80%，報0.29美元。
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譯文內容由第三人軟體翻譯。
