As the Third Wave begins to deciminate South America, Europe, India and even parts of North America, what is the future of our lungs? What therapies can improve them given that we are ourselves exposed and perhaps even hospitalized?
These are insane times for our health and well-being, not just due to the pandemic but due to the rising rate of long-haulers and hospitalization increases among people under 45. There simply aren’t great therapies if your lungs are under threat.
The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency.
RELIEF THERAPEUTICS Holding SA is a Switzerland-based biopharmaceutical company. The Company’s objective is to provide patients with therapeutic relief in serious diseases with high unmet medical need, as well as to focus on developing treatments for respiratory diseases. Relief Therapeutics have received next to no mainstream American News coverage.
It specializes in clinical-stage projects based on molecules of natural origin (peptides and proteins with a history of clinical use and either initial human activity with efficacy data or a strong scientific rationale. Its lead compound is RLF-100 (aviptadil), a synthetic human vasoactive intestinal peptide (VIP) with a multifaceted mode of action in respiratory indications.
To be clinically significant, remember you need a P value of 0.05 or less. When the p value is . 05 or less, we say that the results are statistically significant. There is some confusion it appears over the efficacy of their 2b/3 Trials.
According to NeuroRx, across all patients and sites, RLF-100(TM) met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site. They did not quite meet statistically significant levels, however that’s not to say that VIP won’t become the future standard of treatment.
Long term damage to lungs, heart and neurological (brain organ) is really a potential issue for around 20% of those who contract Covid-19 + 10% of children who contract a VOC (variant of concern). Why would you not be administering a synthetic human vasoactive intestinal peptide (VIP)? This suggests that Relief Therapeutics could eventually receive EUAs.
- The prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals.
- In this group, RLF-100(TM) patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036).
Those figures aren’t incredible, but they are promising. If you can increase survival by 20%, you definately should administer that therapy. This doesn’t take into account how much lung damage you might be preventing and how much relief you are giving patients in their recovery from hospitalization.
- 84% of HFNC patients treated at tertiary medical centers with RLF-100(TM) survived to day 60 compared with 60% of those treated with placebo (P = .007).
Here it almost looks like it’s a 25% gain for a mortality reduction. While I think that is overly optimistic, more studies could make Relief Therapeutics among the most useful future therapies in the Third Wave. The problem with the Third Wave is there is widespread Covid-19 fatigue and lockdown fatigue where younger people are exposing themselves due to a “getting on with their lives” at all costs mentality.
You can see this in India, Canada and regions of the U.S. yet to feel the wrath of the Third Wave in its full brutality.
On the basis of these findings, NeuroRx confirmed plans to apply immediately to the United States Food and Drug Administration for Emergency Use Authorization and to subsequently submit a New Drug Application. Relief Therapeutics are working with NeuroRx and other partners to develop more data on how significant the impact of their treatment could be.
When you look at the data Relief Therapeutics’ treatment could indicate that:
- RLF-100 blocks the COVID-19 Virus to some degree
- Prevents or inhibits cytokine storm
- Heals the lungs and improves blood oxygenation with a mortality reduction (of perhaps around 20%, probably higher in more severe cases)
- Could reduce lung damage in people most at risk for long hauler syndrome
Once the full data set has been obtained, Relief will reach out to European regulators to present the outcomes of the Phase 2b/3 clinical trial. A European Phase 2b/3 clinical trial is planned to be initiated later in 2021. But will all of this be in time for the Third Wave? That remains unclear.
Also what is the chance of a U.S. FDA EUA or fast-tracking of some kind since they have significant vaccine roll-out already in place?
With NeuroRX doing most of the lead for the PR, Relief Therapeutics is a backwater Swiss biotech firm that mostly only Germans know about. Yet they have a proven product pipeline and multiple partners with a diversification of products. Wouldn’t you want your lungs to have a treatment that has this kind of track record so far in 2b/3 trials?
Given the bear market for Micro-cap OTC markets, this stock could actually go down below $0.30 and approach an interesting buying opportunity. The OTC markets have been hit hard in March and it’s unclear if April will be any different.
Inflation worries is making the Russell 2000 very volatile and the stock market remains at all-time highs that have essentially reached their theoretical ceiling even with all the printed money, there’s only one way to go and that’s down.
Given the damage of the Third Wave, intravenously-administered ZYESAMI™ could be the relief we need, but we might not get it, we might not have access to it in time. NeuroRx claims it is statistically significant but the stock market is not acting like it is, so it’s a bit of a mystery.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals.
It’s unclear what the fate of Relief Therapeutics is but it’s a highly intriguing Covid-19 stock play for the Spring of 2021 to watch. You can see NeuroRX’s website here. You can read about their collaboration here. With France and Germany likely going to have to take stricter lockdown measures, Europe would be crazy not to fast-track an EUA for ZYESAMI™.
There simply aren’t that many Covid-19 therapies up to the job of protecting our lungs during the Third Wave. The Third Wave in the Fall is what should really worries ICUs and health care systems and the general public. At the Last Futurist we are bullish on $RLFTF especially if it gets to a price point of $0.25.
If the further data checks out, it could have obviously tremendous upside and impact how hospitalized Covid-19 patients are dealt with. Considering ICUs will be way over-capacity in the coming months, it’s getting really serious to find effective treatments that work and protect our lungs.
Relief Therapeutics $RLFTF is a topic on the Germany based investing community, Investor Team. Credit to them for sharing some of our material on the Covid-19 stock pick. On the SIX Swiss Exchange, it is ticker $CHF with a price of 0.29. The current American price is $0.31.
Given the bear momentum for OTC stocks it could go down to $0.24, where it would be worth picking up. With a stronger catalyst, how high could it go? That remains a matter of speculation. But what did $OCGN or $NVAX teach us about volatility for Covid-19 related stocks? I’ll let the markets decide. According to WallInvestor the biotech stock has considerable upside for the long-term.