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Post by awesomo on Aug 4, 2021 10:47:25 GMT -5
Market lets out a collective "MEH".
NRXP down 4.7%
MNKD being buoyed by UTHR (now up 14.8%), but fading also.
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Post by mannmade on Aug 4, 2021 10:51:32 GMT -5
Therapeutics vs vaccines, which will hold up to the test of time as more variants present themselves? My bet is on therapeutics. Even a vaccine hesitant individual would likely reach for therapy if/when they were to show symptoms of illness. Too late for a vaccine at that point, but a therapy may just save their life. I suspect it will be both, especially where children are concerned and in the third world for vaccines. What I mean is that even if vaccines are not completely successful in preventing the onset of variants as they emerge, they seem to almost uninamously prevent severe symtoms/effects and hospitalization/death. So if vaxxed and a person catches covid, they may be treated with a therapeutic as well to make it go away faster than the common cold... |
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Post by nylefty on Aug 4, 2021 11:04:56 GMT -5
NRx Pharmaceuticals has reported that its investigational drug, Zyesami (aviptadil), statistically significantly prevented a steep surge in cytokines or cytokine storm in Covid-19 patients in a Phase IIb/III trial.
The trial’s prespecified goal was to analyse the change in cytokine level, as cytokines are linked to mortality in Covid-19 patients, NRx noted.
A rapid surge in interleukin 6 (IL-6), an inflammatory cytokine, may also cause lethal conditions such as acute respiratory distress syndrome.
The Phase IIb/III trial analysed Zyesami against placebo in critically ill Covid-19 patients with respiratory failure.
The drug’s effect was observed in a broad set of subjects with varying levels of disease severity and treated in tertiary care as well as community hospitals.
Data showed that trial subjects receiving placebo had a statistically substantial rise in IL-6 cytokine levels while those in the Zyesami arm experienced a lower rise in IL-6.
Zyesami’s anti-cytokine effect was also related to a substantial decline in 60-day mortality, the company noted.
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Post by Clement on Aug 4, 2021 11:57:01 GMT -5
Did you guys check out the pedigree of the board of NRXP?
from the PR:
NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits, and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.
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Post by longliner on Aug 4, 2021 13:22:22 GMT -5
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Post by itellthefuture777 on Aug 4, 2021 13:35:09 GMT -5
We are excited about our partnership with MannKind. Al Mann was one of the most inspiring people I have had the honor to know. Hopefully, his vision will advance the ways in which aviptadil benefits patients and families. Most importantly, the Technosphere system is already FDA-approved and in manufacture, so our challenge is to add a lifesaving drug. #covidー19 #ZYESAMI #Aviptadil #NRx www.linkedin.com/feed/update/urn:li:activity:6828641120524759040/ |
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Post by peppy on Aug 4, 2021 13:38:37 GMT -5
Both intravenous and inhaled formulations of ZYESAMI are in phase 3 clinical trials funded by the U.S. National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA), and by NRx. |
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Post by dh4mizzou on Aug 4, 2021 13:47:38 GMT -5
"......inhaled formulations of ZYESAMI..."
But that is not the Technosphere version, right? How much time do we add on for that review and approval?
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Post by peppy on Aug 4, 2021 14:09:00 GMT -5
"......inhaled formulations of ZYESAMI..."But that is not the Technosphere version, right? How much time do we add on for that review and approval? That wasn't clear..... I remember a few weeks ago a post paraphasing, MC said, "They know where to find us." |
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Post by itellthefuture777 on Aug 4, 2021 14:26:42 GMT -5
Aviptadil acetate is an analog vasoactive intestinal polypeptide (VIP) with potent vasodilatory effects. Aviptadil acetate induces pulmonary vasodilation and inhibits vascular SMCs proliferation, platelet aggregation. Aviptadil acetate can be used for the research of pulmonary fibrosis, pulmonary arterial hypertension (PAH) and SARS-CoV-2 caused respiratory failure, et al[1].
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Post by itellthefuture777 on Aug 4, 2021 14:34:03 GMT -5
Aviptadil acetate is an analog vasoactive intestinal polypeptide (VIP) with potent vasodilatory effects. Aviptadil acetate induces pulmonary vasodilation and inhibits vascular SMCs proliferation, platelet aggregation. Aviptadil acetate can be used for the research of pulmonary fibrosis, pulmonary arterial hypertension (PAH) and SARS-CoV-2 caused respiratory failure, et al[1]. UTH may want to add this..hmm |
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Post by neil36 on Aug 4, 2021 18:40:12 GMT -5
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Post by peppy on Aug 4, 2021 18:53:51 GMT -5
Zyesami (Aviptadil) COVID-19 Therapeutic Description Zyesami (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. NRx was the first to formulate aviptadil (the synthetic form of VIP) for human intravenous and inhaled use under the "Good Manufacturing Practices" standards required by the U.S. FDA and other regulators in 2020. Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the company. VIP is known to target the VPAC1 receptor of the alveolar type II cell (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFα levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.  I learned somewhere along the line, every alveoli has a type two cell. |
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Post by goyocafe on Aug 4, 2021 20:52:21 GMT -5
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Post by boca1girl on Aug 4, 2021 21:31:16 GMT -5
TFF is still a clinical stage development company. Maybe NRX decided to abandoned them in favor of MNKD’s FDA approved Technosphere. |
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