i********r
发帖数: 139 | 1 【 以下文字转载自 Military 讨论区 】
发信人: iminosugar (伪糖), 信区: Military
标 题: aviptadil 第一个治疗重症COVID19病人的有效的药物？
发信站: BBS 未名空间站 (Thu Oct 14 11:01:57 2021, 美东)
NRx Pharmaceuticals（纳斯达克股票代码：NRXP）今天宣布发布一项前瞻性、开放标
签、行政控制试验的同行评审结果，该试验用于治疗重症 COVID-19 患者的呼吸衰竭。
该研究报告了 81% 接受 aviptadil 治疗的患者的 60 天生存率，而在休斯顿卫理公
会医院接受标准护理治疗的患者生存率为 21% (P<.0001)。 |
V*****2
发帖数: 7930 | |
i********r
发帖数: 139 | 3 methodist hospital还是很靠谱的吧？ |
V*****2
发帖数: 7930 | 4 About ZYESAMI™ (aviptadil) in COVID-19
Aviptadil is a synthetic form of Vasoactive Intestinal Polypeptide (VIP),
first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is
named in his honor. Although primarily concentrated in the lung, it was
first purified from the intestinal tract. VIP binds specifically to the
alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it
has been shown to have potent anti-inflammatory/anti-cytokine activity in
animal models of respiratory distress, acute lung injury, and inflammation.
Most importantly, VIP stimulates ATII cells to make the surfactant that must
coat the lining of the lungs in order for them to exchange oxygen with the
blood. Loss of surfactant causes respiratory failure and alveolar collapse,
which are hallmarks of COVID-19.
COVID-19-related respiratory failure is caused by selective infection of the
ATII cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because of
their (ACE2) surface receptors, which serve as the route of entry for the
virus. Coronavirus infection of the ATII cell shuts down surfactant
production, triggers the formation of inflammatory cytokines, and causes
cell death (cytopathy). VIP is shown to upregulate surfactant production,
block Coronavirus replication in the ATII cell, block cytokine synthesis,
and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™,
no currently proposed treatments for COVID-19 specifically target this
mechanism of action. |
V*****2
发帖数: 7930 | 5 没怎么看懂Vasoactive Intestinal Polypeptide (VIP)怎么就能治愈重症病人的，换
救80%的重症病人，还真了不起。 |
V*****2
发帖数: 7930 | 6 Aviptadil+SOC (n=21) Standard Care (n=24
https://infectious-diseases-and-treatment.imedpub.com/vip-in-the-treatment-
of-critical-covid19-with-respiratory-failure-in-patients-with-severe-
comorbidity-a-prospective-externally.pdf
病例少了那么点。不过，能拯救80%重症，是值得FDA考虑特批了。 |
V*****2
发帖数: 7930 | |
i********r
发帖数: 139 | 8 呼吸衰竭死亡的占多少比例？30-40%？如果结果可靠，生存率增加4倍的话，每天就是
上1000条人命。
【在 V*****2 的大作中提到】
: Aviptadil+SOC (n=21) Standard Care (n=24
: https://infectious-diseases-and-treatment.imedpub.com/vip-in-the-treatment-
: of-critical-covid19-with-respiratory-failure-in-patients-with-severe-
: comorbidity-a-prospective-externally.pdf
: 病例少了那么点。不过，能拯救80%重症，是值得FDA考虑特批了。
|
V*****2
发帖数: 7930 | 9
【在 V*****2 的大作中提到】
: 这结果实在好得让人难以相信。
|
i********r
发帖数: 139 | 10 好像治疗组病人的入组指标都要优于对照组，比如BMI 29.5 vs 33.2。
【在 V*****2 的大作中提到】
: 这结果实在好得让人难以相信。
|
V*****2
发帖数: 7930 | 11 对的，BMI是一个问题，另外治疗组里面女的比例高，一般情况女的死亡率比男的低。
【在 i********r 的大作中提到】
: 好像治疗组病人的入组指标都要优于对照组，比如BMI 29.5 vs 33.2。
|
V*****2
发帖数: 7930 | 12 不知FDA会不会来个死马当活马医，来个特批，先治疗一阵看看效果，是不是真的能救
命。 |
V*****2
发帖数: 7930 | 13 不管怎样，可以上一丁点股票，赌一把，还是值得的。别上太多，免得外婆。 |
V*****2
发帖数: 7930 | 14 It was agreed with FDA and the IRB that the most highly comorbid
patients (e.g. transplant patients, those on Extracorporeal
Membrane Oxygenation (ECMO), and those with malignancy or
serious cardiac conditions) with a mortality expectation in excess
of 70% would be excluded from randomization and treated under
Expanded Access Protocol (NCT04453839). In addition, FDA
guidance identifies the appropriateness of a non-randomized
design in highly lethal conditions where there is the potential to
observe a dramatic treatment effect [16].
上的都是超级重症病人。这里面还真不好说。不管怎样，赌一把，还是值得的。 |
V*****2
发帖数: 7930 | 15 现在才8亿的盘子。只要来个特批，股价再翻几倍应该没问题。 |
i********r
发帖数: 139 | 16 是的。看了一下Rothman Index，还是有些差别。
【在 V*****2 的大作中提到】
: It was agreed with FDA and the IRB that the most highly comorbid
: patients (e.g. transplant patients, those on Extracorporeal
: Membrane Oxygenation (ECMO), and those with malignancy or
: serious cardiac conditions) with a mortality expectation in excess
: of 70% would be excluded from randomization and treated under
: Expanded Access Protocol (NCT04453839). In addition, FDA
: guidance identifies the appropriateness of a non-randomized
: design in highly lethal conditions where there is the potential to
: observe a dramatic treatment effect [16].
: 上的都是超级重症病人。这里面还真不好说。不管怎样，赌一把，还是值得的。
|
V*****2
发帖数: 7930 | 17 这种救命关头，FDA或许大笔一挥，就上了。反正最多医疗系统损失点钱。真的能救命
，就积德了。
【在 i********r 的大作中提到】
: 是的。看了一下Rothman Index，还是有些差别。
|
V*****2
发帖数: 7930 | 18 VIP in the Treatment of Critical COVID-19 With Respiratory Failure in
Patients With Severe Comorbidity: A Prospective Externally-Controlled Trial
13 Pages Posted: 4 Aug 2020 Last revised: 5 Oct 2021
可能有点上当，这文章去年8月份就投稿了，刚被接受发表。
这一年过去了，FDA没批准。不知这一年里，是不是又补充了啥结果。 |
i********r
发帖数: 139 | 19 发现不对劲就赶紧跑吧。
Trial
【在 V*****2 的大作中提到】
: VIP in the Treatment of Critical COVID-19 With Respiratory Failure in
: Patients With Severe Comorbidity: A Prospective Externally-Controlled Trial
: 13 Pages Posted: 4 Aug 2020 Last revised: 5 Oct 2021
: 可能有点上当，这文章去年8月份就投稿了，刚被接受发表。
: 这一年过去了，FDA没批准。不知这一年里，是不是又补充了啥结果。
|
V*****2
发帖数: 7930 | 20 https://www.biopharmcatalyst.com/company/NRXP
Phase 2b/3 trial met primary endpoint - March 29, 2021. EUA filing submitted
June 1, 2021. New data showed an improvement in blood oxygen levels August
30, 2021. Phase 2b/3 one year data showed a 3-fold advantage in likelihood
of being alive at one year post treatment (60% vs. 20%), noted September 27,
2021. Data from ineligible subjects for the Phase 2b/3 trial recorded a 60-
day survival in 81% of those treated with aviptadil, compared to 21%
survival among those who received standard of care treatment, noted October
14, 2021.
EUA在6月1日就递交了，还没被批准。只是还是有希望被紧急授权的。 |
V*****2
发帖数: 7930 | 21 没上多少钱，没事。赌一把还是值得的。
【在 i********r 的大作中提到】
: 发现不对劲就赶紧跑吧。
:
: Trial
|
i********r
发帖数: 139 | 22 好像是这几天又补充了一些材料。
submitted
August
27,
60-
October
【在 V*****2 的大作中提到】
: https://www.biopharmcatalyst.com/company/NRXP
: Phase 2b/3 trial met primary endpoint - March 29, 2021. EUA filing submitted
: June 1, 2021. New data showed an improvement in blood oxygen levels August
: 30, 2021. Phase 2b/3 one year data showed a 3-fold advantage in likelihood
: of being alive at one year post treatment (60% vs. 20%), noted September 27,
: 2021. Data from ineligible subjects for the Phase 2b/3 trial recorded a 60-
: day survival in 81% of those treated with aviptadil, compared to 21%
: survival among those who received standard of care treatment, noted October
: 14, 2021.
: EUA在6月1日就递交了，还没被批准。只是还是有希望被紧急授权的。
|
V*****2
发帖数: 7930 | 23 https://www.nrxpharma.com/nrx-pharmaceuticals-announces-improved-survival-at
-one-year-in-highly-comorbid-covid-19-patients-treated-with-zyesami-
aviptadil/
Participants in this trial have now been followed for one year from initial
enrollment. Top-line results show a statistically significant (P<.0001) 3-
fold advantage in likelihood of being alive at one year post treatment (60%
vs. 20%) among those treated with ZYESAMI, in addition to standard of care,
compared to those who received the standard of care alone.
这个或许还行，是在NIH资助下完成的，存活率60%对20%，也还算不错。
【在 i********r 的大作中提到】
: 好像是这几天又补充了一些材料。
:
: submitted
: August
: 27,
: 60-
: October
|
