Annovis Announces Unblinding of the Buntanetap Phase III Data in Parkinson's Disease
Annovis Announces Unblinding of the Buntanetap Phase III Data in Parkinson's Disease
Thu, 09 May 2024
2024 年 5 月 9 日星期四
MALVERN, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson's disease (PD). Topline efficacy data is expected in June.
宾夕法尼亚州马尔文，2024年5月9日（GLOBE NEWSWIRE）——开发神经退行性疾病新疗法的临床阶段药物平台公司Annovis Bio, Inc.（纽约证券交易所代码：ANVS）（“Annovis” 或 “公司”）今天宣布，成功完成了对早期帕金森氏病（PD）患者buntanetap的III期研究的数据清理。主要疗效数据预计将于6月公布。
The Phase III study was completed in 4Q 2023 with an original plan for data announcement in 1Q 2024, however the Company faced a delay in the process of data cleaning beyond the original prognosis. Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, explains in detail the reason behind this delay:
第三阶段研究于2023年第四季度完成，最初计划在2024年第一季度公布数据，但是该公司在数据清理过程中面临延迟，超出了最初的预期。Annovis创始人、总裁兼首席执行官玛丽亚·马切基尼博士详细解释了延迟的原因：
"When we reached the point of unblinding the data for the PD Phase III study, we discovered an unexpected issue: too many plasma samples showed no presence of buntanetap. We were expecting 33% blank samples from the placebo group, but we saw over 50% blank samples. We were afraid that we had mixed up bottles and that patients weren't given what they were supposed to. If that had happened, the study would have been worthless. We promptly started searching for a possible explanation at every step of the way. We checked the content of the bottles – correct. We checked the distribution of the bottles – correct. We checked the labeling of the plasma samples – correct. We checked the distribution of the plasma samples – correct. So, we were left with the pharmacokinetic (PK) measurements. PK is measured by LC-MS/MS with a very expensive set of equipment under GLP, GCP, GMP, and is regulated by very strict FDA rules. It turns out that the group, which was evaluating the PK, modified the method, unfortunately affecting the measurements. We repeated the PK of the same samples and obtained an expected 33% of blank samples accounting for placebo.
“当我们达到解密PD III期研究数据的地步时，我们发现了一个意想不到的问题：太多的血浆样本显示不存在buntanetap。我们原本预计安慰剂组中有33％的空白样本，但我们看到的空白样本超过50％。我们担心自己把瓶子弄混了，而且病人得不到他们应该得到的东西。如果发生这种情况，这项研究将毫无价值。我们立即开始在每一步寻找可能的解释。我们检查了瓶子里的东西，没错。我们检查了瓶子的分布情况——正确。我们检查了血浆样本的标签——正确。我们检查了血浆样本的分布——正确。因此，我们只剩下药代动力学（PK）测量结果。PK 由 LC-MS/MS 测量，使用一套非常昂贵的设备，符合 GLP、GCP、GMP，并受非常严格的美国食品和药物管理局法规的监管。事实证明，正在评估PK的该小组修改了方法，不幸的是影响了测量。我们重复了相同样本的PK，预计占安慰剂的空白样本的33％。
The whole process took us 2 months, which caused the delay in data announcement. However, due to our effort and immediate actions, we are now confident and ready to evaluate the data for the public and the FDA and report topline results in June.
整个过程花了我们两个月，这导致了数据公布的延迟。但是，由于我们的努力和立即采取的行动，我们现在有信心并准备为公众和美国食品药品管理局评估数据，并在6月报告主要结果。
Thank you very much for your understanding and patience."
非常感谢你的理解和耐心。”
About Annovis Bio, Inc.
关于 Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and X (formerly known as Twitter).
Annovis Bio, Inc. 总部位于宾夕法尼亚州马尔文，是一家临床阶段的药物平台公司，致力于治疗神经变性，例如阿尔茨海默氏病（AD）、帕金森氏病（PD）和其他慢性神经退行性疾病。据信它是唯一一家同时开发AD和PD药物的公司，该药物旨在抑制一种以上的神经毒性蛋白质，以恢复轴突和突触活性。通过改善大脑功能，该公司的目标是治疗与AD相关的记忆力减退和痴呆以及与PD相关的身体和大脑功能障碍。有关Annovis Bio的更多信息，请访问该公司的网站 www.annovisbio.co 然后关注我们 领英 和 X（原名推特）。
Forward-Looking Statements
前瞻性陈述
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
本新闻稿包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的 “前瞻性” 陈述。除历史事实陈述以外的所有陈述均可被视为前瞻性陈述。该公司建议谨慎对待前瞻性陈述。前瞻性陈述包括但不限于公司与临床试验相关的计划。这些陈述涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致实际结果与前瞻性陈述所暗示的结果存在重大差异，包括患者入组、Buntanetap的有效性以及公司评估buntanetap疗效、安全性和耐受性的临床试验的时机、有效性和预期结果。另请参阅公司向美国证券交易委员会提交的定期文件中列出的其他风险因素，包括但不限于公司向美国证券交易委员会提交的10-K表年度报告和10-Q表季度报告中 “风险因素” 部分中列出的风险和不确定性。本新闻稿中的所有前瞻性陈述均基于公司截至本申报之日获得的信息。除非适用法律要求，否则公司明确表示不承担任何更新或修改其前瞻性陈述的义务，无论是由于新信息、未来事件还是其他原因。
Investor Contact:
投资者联系人：
Maria Maccecchini, Ph.D.
玛丽亚·马切基尼博士
Source: Annovis Bio Inc.
资料来源：Annovis Bio Inc.
译文内容由第三方软件翻译。