Relief Therapeutics and its shareholders have had a tough couple of days. This came as fear, uncertainty, and doubt (FUD) spread throughout the markets due to a clueless Swiss firm peddling some nonsense. The good news is that the stock drop has nothing to do with the fundamentals. As we will explain in this article, now is the perfect opportunity to either start a new position in Relief Therapeutics or add to an existing position.
RELIEF THERAPEUTICS Holding AG focuses primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and uses in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent (US8178489 formulation for aviptadil) for RLF-100 and proprietary manufacturing processes for its synthesis.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and in the US on the OTC Markets under the symbol RLFTF.
The reason for the drop was a quote from a clueless Swiss firm suggesting that PhaseBio’s trial halt bodes poorly for Relief Therapeutics. On the contrary, as explained by Dr. Javitt a few weeks ago, PhaseBio’s drug targeted VCAP1, a vasodilator, while RLF-100 targets a different receptor, VCAP2. These are two entirely different receptors and are like apples and oranges. Those of us familiar with PhaseBio have been aware of this for a long time.
The ignorant analyst said Relief’s Aviptadil is pretty much the same as PhaseBio’s drug, so Relief’s Trial will also prove to be ineffective. Thus, we got panic-selling in the market.
Continuation of RLF-100 Trial
To calm the waters, Relief Therapeutics just put out a critical update. The independent Data Monitoring Committee (DMC) voted unanimously that NCT 04311697 should continue as planned to its full enrollment of 165 patients.
Specifically, the committee identified no safety concerns and viewed the study as capable of reaching its prespecified endpoint (i.e. no finding of futility) in potentially proving that RLF-100™ (aviptadil) is superior to placebo in achieving recovery from Respiratory Failure in Patients with Critical COVID-19 at a statistically significant level.
The review by the DMC was based on data from 102 patients who were randomly assigned to intravenous RLF-100™ vs. placebo and who have completed 28 days or more of observation. All patients were hospitalized in intensive care units with respiratory failure treated by mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen.
So far, 133 patients have been treated in this protocol. At current rates of enrollment (which may change as infection rates change), the study is expected to complete enrollment by mid-December and yield top-line data in January 2021.
Although the study remains blinded, the randomized data overall show that there have been no drug-related Serious Adverse Events to date. Similarly, no drug-related adverse events were seen in either the open-label study of the ongoing Expanded Access Protocol.
In contrast to other recently-reported trials, the RLF-100™ phase 2b/3 trial focuses on patients with Critical COVID-19 who already require intensive care for Respiratory Failure. Currently, there is no approved drug that has shown efficacy in this population, nor are there late-stage trials of other experimental therapeutics focusing on these patients.
The seven-person DMC included two independent biostatisticians, an epidemiologist/clinical trials expert, a bioethicist, a public representative, and clinical experts in pulmonary and critical care medicine.
Besides the PR, Dr. Javitt spoke to Reuters.
“A couple of weeks after the end of the fourth quarter is what we’re expecting right now,” Jonathan Javitt, founder and chief executive of NeuroRx, said, telling Reuters that the new deadline reflects challenges in running a trial in the midst of a pandemic, including keeping staff safe.
In September, NeuroRx, Inc. submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100™ aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said:
“The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs. Our staff is working around the clock to address requests for RLF-100™ under the appropriate mechanism. All too often, patients of color and those of lower socioeconomic status are denied access.”
The submission is the first step. We expect approval to be granted as the FDA’s guidance to industry identifies the criteria for EUA as safe and “may be effective,” in contrast to the far more stringent requirement of “safe and effective” required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true in the COVID-19 pandemic.
We are now just waiting for a PR that EUA has been approved. Some are speculating that a EUA won’t come until we have reached a full enrollment of 165 patients; however, we believe that is not the case as there’s already enough data from the 133 patients for a EUA to be granted. The fact is people are dying every day from COVID-19 and the U.S. just recorded over 100,000 new daily cases. There is an urgent need and that is what a EUA is for.
Relief Therapeutics Bottom Line
No other treatment has shown the rate of improvement as RLF-100, not Remedisivir, and not Leronlimab. This is huge news and why RLFTF stock is a bargain at a $1.54 billion market cap. All indications are that RLF-100 is effective and we are now waiting for a EUA and top-line data in January.
We now have a timeline for Relief Therapeutics. We said RLFTF was undervalued before the recent drop. At current levels, Relief Therapeutics is an absolute steal. For all these reasons, we believe RLFTF is a must-own.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:RLFTF or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.