Relief Therapeutics
Feb 10, 2021
This is a great video that gives an excellent explanation of how the drug works, what they think it does, and then he reviews the summary of the data released so far. Whiteboard doctor
This is a great video that gives an excellent explanation of how the drug works, what they think it does, and then he reviews the summary of the data released so far. Whiteboard doctor
Feb 9, 2021
Some of you did your own research and joined me in investing in RLFTF. This is just my thoughts on the company, the drug, and the investment in general.
They released some topline data from the clinical trial today, Tue Feb 9. The results were good, but not great. The primary endpoint was not achieved, although they haven't fully unblinded all of the data for that yet. It's unlikely the primary endpoint will be met. Several secondary endpoints were met, however, including reducing days in the hospital on average between 5 and 11 days, depending on the condition of the patient at the beginning of treatment.
Investors do not like the news and the share price is down 30%. Honestly, I thought it would drop 50% or more. There appears to still be a very realistic hope for getting Emergency Use Authorization (EUA) from the FDA. Any help getting patients out of ICU and home faster would, presumably, be welcomed by the medical community, but we have to see what the FDA thinks.
The trial is still following patients to day 60. It's possible there may be a dramatic improvement at day 60. Previous unblinded and open label studies showed a significant improvement between day 28 and day 60.
I am not selling my shares in RLFTF at this time. I feel that the additional trial results, while not a homerun, may still prove to be very valuable and the drug may still receive EUA and eventually full FDA approval. I had been intending to hold for 12 - 24 months because there seem to be other indications (COPD, ARDS, asthma, acute lung injury), and I don't think today's news changes that, for me. Additionally, if granted EUA, there would be a nice spike in the share price at that time. I encourage you to make your own decision. You're welcome to ask for additional input. I do follow this drug company quite closely.
Some of you did your own research and joined me in investing in RLFTF. This is just my thoughts on the company, the drug, and the investment in general.
They released some topline data from the clinical trial today, Tue Feb 9. The results were good, but not great. The primary endpoint was not achieved, although they haven't fully unblinded all of the data for that yet. It's unlikely the primary endpoint will be met. Several secondary endpoints were met, however, including reducing days in the hospital on average between 5 and 11 days, depending on the condition of the patient at the beginning of treatment.
Investors do not like the news and the share price is down 30%. Honestly, I thought it would drop 50% or more. There appears to still be a very realistic hope for getting Emergency Use Authorization (EUA) from the FDA. Any help getting patients out of ICU and home faster would, presumably, be welcomed by the medical community, but we have to see what the FDA thinks.
The trial is still following patients to day 60. It's possible there may be a dramatic improvement at day 60. Previous unblinded and open label studies showed a significant improvement between day 28 and day 60.
I am not selling my shares in RLFTF at this time. I feel that the additional trial results, while not a homerun, may still prove to be very valuable and the drug may still receive EUA and eventually full FDA approval. I had been intending to hold for 12 - 24 months because there seem to be other indications (COPD, ARDS, asthma, acute lung injury), and I don't think today's news changes that, for me. Additionally, if granted EUA, there would be a nice spike in the share price at that time. I encourage you to make your own decision. You're welcome to ask for additional input. I do follow this drug company quite closely.
Further thoughts about the results so far:
So....patients who received Zyesami did not survive better, but those who did survive were discharged sooner, by 5 to 11 days. Interesting. I wonder why some patients seems to respond while others didn't. The patients who didn't respond died at the same rate as those in the placebo group. But those patients who did respond, saw dramatic improvement. I was in the ICU for 3 nights a couple years ago after my spine surgery. It's scary, expensive, and consumes a LOT of resources: one nurse manages only 2 patients as opposed to a regular floor where a nurse manages 8 patients or so. Reducing ICU duration would be a big deal.
So....patients who received Zyesami did not survive better, but those who did survive were discharged sooner, by 5 to 11 days. Interesting. I wonder why some patients seems to respond while others didn't. The patients who didn't respond died at the same rate as those in the placebo group. But those patients who did respond, saw dramatic improvement. I was in the ICU for 3 nights a couple years ago after my spine surgery. It's scary, expensive, and consumes a LOT of resources: one nurse manages only 2 patients as opposed to a regular floor where a nurse manages 8 patients or so. Reducing ICU duration would be a big deal.
Also...since you probably don't follow as closely as I do.... there's still a lot to learn about the drug. they are starting a clinical trial to test it in inhaled form, much earlier in the treatment of the virus. That might produce better results. I've said that all along. It seems to prevent the virus from getting in via the type 2 alveolar cells. It might work better as a preventative medication.
Press release about the initial topline results:
finance.yahoo.com/news/neurorx-reports-initial-phase-2b-131300609.html
finance.yahoo.com/news/neurorx-reports-initial-phase-2b-131300609.html
Posted on an investor board I frequent:
"Friends,
I wanted to address todays call, price action and a few other topics from an Internal Medicine/Hospitalist's perspective. A little about me. I have been here since August. I have 40% of my portfolio invest in RLFTF and 50% invested in the BRPA family. I am still here. I work on the front lines, in a smaller rural community hospital with a rather large catchment area. Most days are spent treating the critical COVID patients. I have seen a lot of death and I have seen some miracles.
The data released today is great but incomplete. As I was reviewing the results I was extremely excited as were many colleagues. Prior to COVID-19, my hospital had 14ish ICU beds. We now have 30 active with the ability to flip 10-15 more to ICU if need be. We have had to shut down 2/3 of the hospital to safely place COVID from non COVID. We have the PACU, ED, Observation piled up with patients because we have no place to put the average patient with Afib, HF, MI, and a variety of other bread and butter illnesses. This is mostly due to length of stay and critical needs.
We have grown in our ability to care for COVID-19 and prolong life. This hurts hospital throughput and has deleterious effects on other patients.
Please understand that prolonging life and mortality are just that. Death. I am not at all surprised about similar 28 day mortality results. A lot of these patients are older and have high fragility index scores, and are already beyond the average life expectancy of the US Citizen. The Golden data showed recovery from respiratory failure and significant reduction in ICU stay and Hospital stay. What does that mean?
It means that my patient didn't end up with a lung transplant. They didn't end up with a Tracheostomy. The didn't need to leave the hospital with a portable oxygen tank. They're quality of life is restored.
One could say that 1 day in the ICU mean 1 week in skilled rehab facility. When you reduce length of stay you have reduced recovery time. You reduced significant cost. You have massively reduced the risk of hospital associated infections and death (think about our Firefighter we all loved). You have reduced the risk of errors.
I look at this data with no doubt of EUA. The benefits are clear.
Turning to price action...I'm speechless. There is no reason for it. I can understand that Dr. J and team could have handled the CC better, but the data is good.
I'll leave you with this. I spoke with every one of my partners today. They all want the drug for EUA now. That is telling."
"Friends,
I wanted to address todays call, price action and a few other topics from an Internal Medicine/Hospitalist's perspective. A little about me. I have been here since August. I have 40% of my portfolio invest in RLFTF and 50% invested in the BRPA family. I am still here. I work on the front lines, in a smaller rural community hospital with a rather large catchment area. Most days are spent treating the critical COVID patients. I have seen a lot of death and I have seen some miracles.
The data released today is great but incomplete. As I was reviewing the results I was extremely excited as were many colleagues. Prior to COVID-19, my hospital had 14ish ICU beds. We now have 30 active with the ability to flip 10-15 more to ICU if need be. We have had to shut down 2/3 of the hospital to safely place COVID from non COVID. We have the PACU, ED, Observation piled up with patients because we have no place to put the average patient with Afib, HF, MI, and a variety of other bread and butter illnesses. This is mostly due to length of stay and critical needs.
We have grown in our ability to care for COVID-19 and prolong life. This hurts hospital throughput and has deleterious effects on other patients.
Please understand that prolonging life and mortality are just that. Death. I am not at all surprised about similar 28 day mortality results. A lot of these patients are older and have high fragility index scores, and are already beyond the average life expectancy of the US Citizen. The Golden data showed recovery from respiratory failure and significant reduction in ICU stay and Hospital stay. What does that mean?
It means that my patient didn't end up with a lung transplant. They didn't end up with a Tracheostomy. The didn't need to leave the hospital with a portable oxygen tank. They're quality of life is restored.
One could say that 1 day in the ICU mean 1 week in skilled rehab facility. When you reduce length of stay you have reduced recovery time. You reduced significant cost. You have massively reduced the risk of hospital associated infections and death (think about our Firefighter we all loved). You have reduced the risk of errors.
I look at this data with no doubt of EUA. The benefits are clear.
Turning to price action...I'm speechless. There is no reason for it. I can understand that Dr. J and team could have handled the CC better, but the data is good.
I'll leave you with this. I spoke with every one of my partners today. They all want the drug for EUA now. That is telling."
From another doctor. Found on Reddit (here's the link - other doctors respond and echo this doctor's points). Get ready to google search a lot of terms. Lol. BTW, when he says VIP, that means vasoactive intestinal peptide. That's the peptide that's found in the human body, mostly in the lungs but originally found in the intestines - hence the name with intestinal. The drug being tested is a synthesized version of this peptide. And Zyesami is the new name for the drug. It's an homage to the research doctor who found the peptide: Dr. Sami Said.
"First, let me say that I am an intensivist and an investor. I have treated a lot of ICU patients with COVID since this pandemic began. Full disclosure, I own RLF and BRPA and firmly believe VIP/Zyesami works.
Today, phase 2/3b IV trial results were released. It is clear that the market failed to understand the gravity of these results. A market sell off occurred because people thought the trial was a failure because survival at 28days was not statistically significant and because the results failed to address the primary end point of resolution of acute respiratory failure.
You see, the patients who are admitted to the ICU with severe respiratory failure, requiring NIPPV, HFNC or mechanical ventilation are often in concomitant multisystem organ failure with multiple comorbidities of advanced age, poorly controlled diabetes, ESRD, heart failure and obesity.
These patients are critically ill and admitted with acute respiratory failure. They are kept on high flow O2 and NIPPV (BIPAP/CPAP) for as long as possible to decrease ventilator associated barotrauma which has been demonstrated to worsen overall survival in COVID induced RDS.
When patients land on the vent, they are worse now than they ever were a year ago when the pandemic first began. This is because, in the beginning, we were afraid NIPPV would aerosolize COVID and cause a larger spread of the disease. As such, now, patients are kept on HFNC and NIPPV longer than ever. That’s why ICUs are full and remain full. These patients have a tenuous respiratory status and can decompensate at a moment’s notice.
The average length of stay for an ICU COVID admission is 25 days. Decreasing ICU length of stay for HFNC and NIPPV patients by half is huge. I cannot say this enough. The average ICU stay costs $5000 a day. Improvement of ICU hospitalization by 15 days vs. 26 days is an average payor (private insurance/Medicare) cost of 75k vs 130k. That’s a savings of 55k per COVID patient.
(https://www.neurorxpharma.com/press-releases/neurorx-and-relief-therapeutics-report-initial-phase-2b-3-study-results-demonstrating-significant-benefit-of-zyesami-in-reducing-hospital-stay-among-patients-with-respiratory-failure-due-to-c/)
The fact that Zyesami is safe, furthermore, cannot be overlooked. Let us compare these results to the current standard of care. In the NEJM article, Remdesivir for the Treatment of Covid-19 — Final Report, the median time to recovery was shorted by only 1 day with overall disease course shortened from 11 days to 10 days. Remdesivir had a number of side effects, including kidney and liver damage with constant for need for monitoring of LFTs/serum creatinine. (https://www.nejm.org/doi/full/10.1056/NEJMoa2007764)
Furthermore, in regards to steroids, current NIH treatment guidelines note that methylprednisolone did not improve all cause mortality, ICU free days or duration of mechanical ventilation. It only improved the number of ICU days alive and free from mechanical ventilation by a difference of 2.3 days.
(https://www.covid19treatmentguidelines.nih.gov/immune-based-therapy/immunomodulators/corticosteroids/)
The trial results today prove that Zyesami is most useful in mild to moderate COVID before permanent lung damage and multisystem organ failure develop. The best recovery was demonstrated by those patients using HFNC. This strongly suggests that Zyesami prevents disease worsening and reverses mild/moderate disease. An inhaled trial is underway for exactly this indication. Given the degree of improvement seen in LOS, it seems likely an EUA will be granted.
You can ask any physician, myself included, what a big deal cutting ICU stay length in half is. They will all tell you that this is a huge improvement in current standard of care. ICU admission increase risk for nosocomial infections, worsening respiratory status and debility. Furthermore, given its positive effect in patients on NIPPV/HFNC, current evidence supports that VIP may have a significant benefit in other respiratory diseases, like COPD, asthma and interstitial pneumonitis.
As such, I think that the market has misunderstood the results to date. Today’s market activity was an over-reaction (just like when this tanked to 29c in Dec). This price activity has already began to correct from a low of 31c to 41c today. I expect prices to begin to recover and people start to understand the gravity of these results in the near future when a full data is released, with comparison xrays, ordinal scales and 28/60 day outcomes. Biotech are volatile by nature, but I am also strongly optimistic for an EUA."
"First, let me say that I am an intensivist and an investor. I have treated a lot of ICU patients with COVID since this pandemic began. Full disclosure, I own RLF and BRPA and firmly believe VIP/Zyesami works.
Today, phase 2/3b IV trial results were released. It is clear that the market failed to understand the gravity of these results. A market sell off occurred because people thought the trial was a failure because survival at 28days was not statistically significant and because the results failed to address the primary end point of resolution of acute respiratory failure.
You see, the patients who are admitted to the ICU with severe respiratory failure, requiring NIPPV, HFNC or mechanical ventilation are often in concomitant multisystem organ failure with multiple comorbidities of advanced age, poorly controlled diabetes, ESRD, heart failure and obesity.
These patients are critically ill and admitted with acute respiratory failure. They are kept on high flow O2 and NIPPV (BIPAP/CPAP) for as long as possible to decrease ventilator associated barotrauma which has been demonstrated to worsen overall survival in COVID induced RDS.
When patients land on the vent, they are worse now than they ever were a year ago when the pandemic first began. This is because, in the beginning, we were afraid NIPPV would aerosolize COVID and cause a larger spread of the disease. As such, now, patients are kept on HFNC and NIPPV longer than ever. That’s why ICUs are full and remain full. These patients have a tenuous respiratory status and can decompensate at a moment’s notice.
The average length of stay for an ICU COVID admission is 25 days. Decreasing ICU length of stay for HFNC and NIPPV patients by half is huge. I cannot say this enough. The average ICU stay costs $5000 a day. Improvement of ICU hospitalization by 15 days vs. 26 days is an average payor (private insurance/Medicare) cost of 75k vs 130k. That’s a savings of 55k per COVID patient.
(https://www.neurorxpharma.com/press-releases/neurorx-and-relief-therapeutics-report-initial-phase-2b-3-study-results-demonstrating-significant-benefit-of-zyesami-in-reducing-hospital-stay-among-patients-with-respiratory-failure-due-to-c/)
The fact that Zyesami is safe, furthermore, cannot be overlooked. Let us compare these results to the current standard of care. In the NEJM article, Remdesivir for the Treatment of Covid-19 — Final Report, the median time to recovery was shorted by only 1 day with overall disease course shortened from 11 days to 10 days. Remdesivir had a number of side effects, including kidney and liver damage with constant for need for monitoring of LFTs/serum creatinine. (https://www.nejm.org/doi/full/10.1056/NEJMoa2007764)
Furthermore, in regards to steroids, current NIH treatment guidelines note that methylprednisolone did not improve all cause mortality, ICU free days or duration of mechanical ventilation. It only improved the number of ICU days alive and free from mechanical ventilation by a difference of 2.3 days.
(https://www.covid19treatmentguidelines.nih.gov/immune-based-therapy/immunomodulators/corticosteroids/)
The trial results today prove that Zyesami is most useful in mild to moderate COVID before permanent lung damage and multisystem organ failure develop. The best recovery was demonstrated by those patients using HFNC. This strongly suggests that Zyesami prevents disease worsening and reverses mild/moderate disease. An inhaled trial is underway for exactly this indication. Given the degree of improvement seen in LOS, it seems likely an EUA will be granted.
You can ask any physician, myself included, what a big deal cutting ICU stay length in half is. They will all tell you that this is a huge improvement in current standard of care. ICU admission increase risk for nosocomial infections, worsening respiratory status and debility. Furthermore, given its positive effect in patients on NIPPV/HFNC, current evidence supports that VIP may have a significant benefit in other respiratory diseases, like COPD, asthma and interstitial pneumonitis.
As such, I think that the market has misunderstood the results to date. Today’s market activity was an over-reaction (just like when this tanked to 29c in Dec). This price activity has already began to correct from a low of 31c to 41c today. I expect prices to begin to recover and people start to understand the gravity of these results in the near future when a full data is released, with comparison xrays, ordinal scales and 28/60 day outcomes. Biotech are volatile by nature, but I am also strongly optimistic for an EUA."
