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Post by uvula on Aug 4, 2021 7:39:05 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. My guess is NRX deserves full credit for the partnership, not MC. Another similarity to Rothblatt. |
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Post by mango on Aug 4, 2021 7:45:07 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. My guess is NRX deserves full credit for the partnership, not MC. Another similarity to Rothblatt. It takes two to form a partnership, but believe whatever makes you happy! |
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Post by Deleted on Aug 4, 2021 7:54:45 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. That was my first thought. If you're in respiratory failure I don't think you will be able to breath deeply? Now maybe this will be administered before respiratory failure occurs??? Similar to EPIHALE? When you feel an attack coming on you inhale EPI before it becomes severe? |
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Post by peppy on Aug 4, 2021 8:00:01 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. That was my first thought. If you're in respiratory failure I don't think you will be able to breath deeply? Now maybe this will be administered before respiratory failure occurs??? Similar to EPIHALE? When you feel an attack coming on you inhale EPI before it becomes severe? First of all, if a person has respiratory failure, an endo tracheal tube needs to be inserted, and the person needs positive pressure ventilation. These COVID people we are talking about have an increased respiratory rate, some are gasping. They can inhale. when they can no longer inhale, a ventilator is needed. and the medication can be put down the endotracheal tube. I spelled it out for you. No abbreviations. PPV. ET tube etc. |
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Post by goyocafe on Aug 4, 2021 8:04:43 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.
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Post by itellthefuture777 on Aug 4, 2021 8:11:33 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. Formulate and load takes 3 months |
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Post by itellthefuture777 on Aug 4, 2021 8:14:09 GMT -5
Also...Technosphere is multimodal..meaning it can be inhaled as a dry powder...can be mixed in a saline solution and injected..or nebulized...it isn't limited..
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Post by peppy on Aug 4, 2021 8:14:42 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. Yes, sir, that's my baby..... Because the lungs function as the body's gas-exchange organ, they are inevitably exposed to air that is contaminated with pathogens, allergens and pollutants. Host-defence mechanisms within the lungs must facilitate clearance of inhaled pathogens and particles while minimizing an inflammatory response that could damage the thin, delicate gas-exchanging epithelium. Pulmonary surfactant is a complex of lipids and proteins that enhances pathogen clearance and regulates adaptive and innate immune-cell functions. In this article, I review the structure and functions of the surfactant proteins SP-A and SP-D in regulating host immune defence and in modulating inflammatory responses. www.nature.com/articles/nri1528Surfactant really really helps alveolar compliance. |
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Post by Clement on Aug 4, 2021 8:30:22 GMT -5
This really hot girl just agreed to go out with me. First date but not a blind date. We have talked and hung out before, but this is our first "date" date. I like her. My parents like her because she's smart and her family is well connected. There are no promises of good things to come out of this ----- but maybe.
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Post by mango on Aug 4, 2021 9:04:29 GMT -5
With clinical effects of aviptadil now emerging in clinical trials, NRx is broadening its focus to develop a simple, room-temperature inhaled delivery system that is convenient for patients and is already proven in commercial manufacture.
Senior FDA officials and others have emphasized the need to develop inhaled drugs to treat COVID and other acute lung disorders in order to increase patient convenience and move treatment from the ICU to the outpatient setting.
"As we continue to identify the beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers multi-year stability at room temperature is key to meeting the needs of patients." said 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."
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This compound is already being used in NRx clinical trials using an inhalation ROA. NRx wants a DPI formulation. This will be a quick turnover time, most likely the exact same pathway we went with Tyvaso DPI. We are also already Fast Tracked.
This is huge.
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Post by sayhey24 on Aug 4, 2021 9:34:14 GMT -5
Mango - I agree this could be huge and it will probably get emergency authorization with TS already being an approved delivery device. I just hope Mike is hitting up BARTA for BIG $$$.
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Post by itellthefuture777 on Aug 4, 2021 9:38:34 GMT -5
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Post by mango on Aug 4, 2021 9:41:16 GMT -5
Mango - I agree this could be huge and it will probably get emergency authorization with TS already being an approved delivery device. I just hope Mike is hitting up BARTA for BIG $$$. Excellent point! I could definitely see that. Let’s hope MC gets that R&D funding next. 🤞 |
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Post by geomean on Aug 4, 2021 10:27:23 GMT -5
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Post by peppy on Aug 4, 2021 10:40:25 GMT -5
With clinical effects of aviptadil now emerging in clinical trials, NRx is broadening its focus to develop a simple, room-temperature inhaled delivery system that is convenient for patients and is already proven in commercial manufacture. Senior FDA officials and others have emphasized the need to develop inhaled drugs to treat COVID and other acute lung disorders in order to increase patient convenience and move treatment from the ICU to the outpatient setting."As we continue to identify the beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers multi-year stability at room temperature is key to meeting the needs of patients." said 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." —————————————————— This compound is already being used in NRx clinical trials using an inhalation ROA. NRx wants a DPI formulation. This will be a quick turnover time, most likely the exact same pathway we went with Tyvaso DPI. We are also already Fast Tracked. This is huge. Quote, " move treatment from the ICU to the outpatient setting." REPLY: This is the ticket. Here is why. Years ago from neonatal intense care units, there were babies who's lungs were so scared from the ventilator, they lived in the hospital in vents. The cost to insurance companies was high. In came SURFACTANT. It stopped the chronic lung, because babies improved and were able to wean off the vent. THE POINT: Save insurance companies enough money they are in. Surfactant is standard of care. |
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