Synaptogenix Announces Peer-Reviewed Publication Of NIH-Sponsored Phase 2 Clinical Trial Results Demonstrating Safe, Significant, And Persistent Benefits Of Bryostatin-1 in Advanced Alzheimer's Disease
Synaptogenix Announces Peer-Reviewed Publication Of NIH-Sponsored Phase 2 Clinical Trial Results Demonstrating Safe, Significant, And Persistent Benefits Of Bryostatin-1 in Advanced Alzheimer's Disease
Bryostatin-1 benefits in severe Alzheimer's disease patients were statistically significant with respect to placebo at p < 0.007
與安慰劑相比，Bryostatin-1對嚴重阿爾茨海默病患者的益處具有統計學意義，p
NEW YORK, Sept. 26, 2023 /PRNewswire/ -- Synaptogenix, Inc. (NASDAQ:SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced a peer-reviewed publication of statistically significant integration of secondary and exploratory endpoint data from its previously completed Phase 2 trial of Bryostatin-1 for Alzheimer's disease. The paper, titled "Advanced Alzheimer's Disease (AD) Patients Show Safe, Significant, and Persistent Benefit in 6 Month Bryostatin Trial," will appear in the Journal of Alzheimer's Disease later this month.
紐約，2023年9月26日 /PRNewswire/ — 開發神經退行性疾病療法的新興生物製藥公司Synaptogenix, Inc.（納斯達克股票代碼：SNPX）（“Synaptogenix” 或 “公司”）今天宣佈了一份經過同行評審的出版物，整合了其先前完成的阿爾茨海默氏症Bryostatin-1二期試驗的次要和探索性終點數據，具有統計學意義疾病。這篇題爲 “晚期阿爾茨海默氏病（AD）患者在爲期6個月的Bryostatin試驗中顯示出安全、顯著和持續的益處” 的論文將於本月晚些時候發表在《阿爾茨海默病雜誌》上。
As stated in the paper, conclusions from analyses of the trial's Severe Cohort indicate that Bryostatin-treated MMSE 10-14 patients showed no significant cognitive decline throughout the 10-month trial, compared with placebo patients' decline of -12.8 SIB points. The paper goes on to discuss persistence in the data, stating, "The prolonged absence of any significant cognitive decline in Bryostatin-treated patients vs. placebo patients – even 16 weeks after the final dose of Bryostatin – suggests a long-lasting positive change in the treated patients' brains."
如論文所述，對該試驗嚴重隊列的分析得出的結論表明，與安慰劑患者下降-12.8個SIB分數相比，接受Bryostatin治療的MMSE 10-14患者的認知能力在爲期10個月的試驗中沒有明顯的認知能力下降。該論文接着討論了數據的持久性，並指出：“與安慰劑患者相比，接受Bryostatin治療的患者長期沒有出現任何明顯的認知能力下降——即使在最後一劑Bryostatin之後16周——也表明接受治療的患者的大腦發生了長期的積極變化。”
Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix, commented, "There is a huge unmet need in the AD population for drugs oriented specifically to advanced and severe patients. Approved drugs do exist for slowing decline in non-demented, Mild Cognitive Impairment (MCI) patients and possible early AD patients, but Bryostatin-1-treated Severe Cohort patients, in contrast, showed no significant cognitive decline across a 10-month span in our study. We believe that Bryostatin-1 for later-stage patients would be complementary to the early-stage AD drugs in providing a full range of treatment options for the more than six million Americans living with Alzheimer's disease."
Synaptogenix首席執行官艾倫·塔赫曼博士評論說：“AD人羣對專門針對晚期和重症患者的藥物的需求尚未得到滿足。確實有批准的藥物可以減緩非癡呆的輕度認知障礙（MCI）患者和可能的早期AD患者的衰退，但相比之下，接受Bryostatin-1治療的嚴重隊列患者在我們的研究中在10個月內沒有出現明顯的認知能力下降。我們認爲，針對晚期患者的Bryostatin-1將補充早期AD藥物，爲600多萬患有阿爾茨海默氏病的美國人提供全方位的治療選擇。”
Dr. Daniel Alkon, President, and Chief Scientific Officer, added, "We appreciate the acknowledgement from such an esteemed independent Alzheimer's journal. Persistence of real benefit at least 16 weeks beyond the final Bryostatin dosing is an extremely important outcome for Alzheimer's patients in the more advanced stages of the disease."
總裁兼首席科學官丹尼爾·阿爾康博士補充說：“我們感謝這樣一本備受尊敬的獨立阿爾茨海默氏症期刊的認可。對於處於更晚期的阿爾茨海默氏症患者來說，在最終的Bryostatin給藥後至少16周內持續獲得真正的益處是一個極其重要的結果。”
About the Phase 2 Trial of Bryostatin-1
關於 Bryostatin-1 的 2 期試驗
Synaptogenix's 6-month Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study comparing Bryostatin-1 to placebo for long-term efficacy in the treatment of advanced and severe AD in the absence of memantine. While Moderate Cohort patients showed no significant benefit, the data demonstrates that Bryostatin-1-treated patients in the Severe Cohort showed statistically significant improvement of cognitive performance over placebo patients for weeks #13 through #42, with the last dose administered at Week #26.
Synaptogenix爲期6個月的2期臨床試驗是一項隨機、雙盲、安慰劑對照研究，比較了Bryostatin-1與安慰劑在不使用美金剛的情況下治療晚期和重度AD的長期療效。雖然中度隊列患者沒有顯示出顯著的益處，但數據表明，在接受Bryostatin-1治療的嚴重隊列中，在第 #13 至 #42 周內，與安慰劑患者相比，接受Bryostatin-1治療的患者的認知能力在統計學上顯著改善，最後一次給藥是在第 #26 周。
The study was conducted with financial support from the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both part of the NIH.
該研究是在美國國立衛生研究院下屬的國家老齡化研究所（NIA）和美國國家癌症研究所（NCI）的財政支持下進行的。
譯文內容由第三人軟體翻譯。