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Post by yash on Aug 4, 2021 6:03:37 GMT -5
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Post by bthomas55ep on Aug 4, 2021 6:14:48 GMT -5
I,of course, am excited about the possibility of this compound, but my first thought when reading the press release is that it feels more like a pre-earnings pump than a real solidified partnership. Don't they normally want to verify the validity of the ability to bind the compound and develop a partnership agreement with royalty structure and phase 1 ind plans before press release? Or is the word COVID so hot,you press it at any event stage? Certainly pulling for them and just hope things are further along than this PR indicates... Good luck to all.
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Post by stockwhisperer on Aug 4, 2021 6:30:55 GMT -5
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Post by mango on Aug 4, 2021 6:33:19 GMT -5
AWESOME news! Congrats everyone!
NRx was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure; currently in clinical trials
Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.
"As we continue to identify beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers stability at room temperature is key to long term success," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "We are pleased to be working with MannKind to develop an inhaled form of ZYESAMI which may offer patients an easier and more therapeutic option."
MannKind will begin exploring formulation potential at its research and manufacturing facility located in Danbury, Conn., which features a full range of development and manufacturing capabilities, including analytical, chemical, formulation, filling and packaging. It has sufficient filling capacity to produce more than 300 million cartridges of inhaled drug annually.
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Post by goyocafe on Aug 4, 2021 6:45:29 GMT -5
How long does it take MNKD to “formulate” a candidate compound? It would be more compelling if this formulation had already taken place prior to a press release. Hope springs eternal, but I tend to agree with bthomas5sep that this seems early in the game to make this announcement.
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Post by anderson on Aug 4, 2021 6:50:42 GMT -5
ir.nrxpharma.com/news-events/press-releases/detail/76/nrx-pharmaceuticals-partners-with-mannkind-corporation-tosaid Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx (see concept image). "I had the privilege of working closely with Dr. Alfred Mann, on the refinement and regulatory approval of MannKind's Technosphere platform and have long admired its simplicity and elegance. On many occasions he and I discussed his vision to extend Technosphere beyond insulin to solve the unique stability and administration challenges of peptide-based drugs. I am personally delighted to be partnering once again with MannKind and bringing Dr. Mann's vision to life."
Also in the article(not MNKD formulation, but a nebulizer)
"Both intravenous and inhaled formulations of ZYESAMI™ are in phase 3 clinical trials funded by the US National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA), and by NRx."
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Post by sayhey24 on Aug 4, 2021 6:53:17 GMT -5
Hopefully Mike can get BARDA or the NIH to provide the R&D funding for this.
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Post by mango on Aug 4, 2021 7:09:58 GMT -5
How long does it take MNKD to “formulate” a candidate compound? It would be more compelling if this formulation had already taken place prior to a press release. Hope springs eternal, but I tend to agree with bthomas5sep that this seems early in the game to make this announcement. Well we already know we can load this compound onto Technosphere since we aren’t conducting a feasibility study—we’re working on the actual formulation for clinical trials. My guess is very quickly considering the drug is already in clinical trials and has Fast Track designation by FDA. Could be a matter of a few months, I’m going to guess by EOY. |
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Post by goyocafe on Aug 4, 2021 7:16:26 GMT -5
How long does it take MNKD to “formulate” a candidate compound? It would be more compelling if this formulation had already taken place prior to a press release. Hope springs eternal, but I tend to agree with bthomas5sep that this seems early in the game to make this announcement. Well we already know we can load this compound onto Technosphere since we aren’t conducting a feasibility study—we’re working on the actual formulation for clinical trials. My guess is very quickly considering the drug is already in clinical trials and has Fast Track designation by FDA. Could be a matter of a few months, I’m going to guess by EOY. ”Exploring formulation potential “ doesn’t instill much confidence that they know they can make this work. I remain hopeful, but MC has played too many hands like this for me to take the hook line and sinker. |
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Post by mango on Aug 4, 2021 7:22:06 GMT -5
Well we already know we can load this compound onto Technosphere since we aren’t conducting a feasibility study—we’re working on the actual formulation for clinical trials. My guess is very quickly considering the drug is already in clinical trials and has Fast Track designation by FDA. Could be a matter of a few months, I’m going to guess by EOY. ”Exploring formulation potential “ doesn’t instill much confidence that they know they can make this work. I remain hopeful, but MC has played too many hands like this for me to take the hook line and sinker. True, but we do actually have VIP in our parents so I believe we already know it can be done. In fact, I believe this partnership will prove to be extraordinary. Think on the level of UT. "I had the privilege of working closely with Dr. Alfred Mann, on the refinement and regulatory approval of MannKind's Technosphere platform and have long admired its simplicity and elegance. On many occasions he and I discussed his vision to extend Technosphere beyond insulin to solve the unique stability and administration challenges of peptide-based drugs. I am personally delighted to be partnering once again with MannKind and bringing Dr. Mann's vision to life." — Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx |
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Post by goyocafe on Aug 4, 2021 7:29:07 GMT -5
Mango, I hope you’re right.
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Post by peppy on Aug 4, 2021 7:30:17 GMT -5
Wed, August 4, 2021, 5:48 AM·4 min read NRx was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure; currently in clinical trials WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI™ (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions. An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure. Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program . Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.
========================================================================================================= mango SURFACTANT. The magic word. (I see COPD) |
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Post by mango on Aug 4, 2021 7:31:46 GMT -5
The CEO of NRx has extensive previous experience and knowledge with Technosphere and personally knew Al Mann. Even said he looks forward to bringing his vision to life.
Sounds like Martine Rothblatt all over again to me.
Time will tell, but I feel good about this partnership.
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Post by uvula on Aug 4, 2021 7:36:20 GMT -5
"Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients..."
So would the inhaled version be used to prevent the respiratory failure in tbe first place? I'm not sure how you inhale something if you have respiratory failure.
Since VIP is already inside us maybe it is safe to give to everyone hospitalized with covid as a preventative.
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Post by mango on Aug 4, 2021 7:38:58 GMT -5
Wed, August 4, 2021, 5:48 AM·4 min read NRx was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure; currently in clinical trials WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI™ (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions. An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure. Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program . Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.
========================================================================================================= mango SURFACTANT. The magic word. (I see COPD) I did think of you peppy when I read surfactant, haha. |
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