TrialSite News, an online digital media and social engagement platform dedicated to open, accessible, and transparent clinical research, receives messages from patients on a daily basis. With COVID-19, an urgency has raised the stakes of each and every communication. Recently, multiple patients were in touch, asking for TrialSite’s support in a desperate bid to help them figure out how to access RLF-100 for severely ill family members infected with SARS-CoV-2. As in one case, a woman’s husband lies in a San Antonio hospital in critical condition with COVID-19-related breathing problems. On a ventilator, the patient’s wife read TrialSite recently and extended outreach to the team for any suggestions. TrialSite explained the emergency use access concept and suggested she contact her husband’s medical team at the hospital immediately to see if that was available. Additionally, TrialSite sent an email communication to the CEO of NeuroRx Inc., the partner to the actual intellectual property owner, Swiss-based Relief Therapeutics (RELIEF). Why? The wife of the critically ill husband was told of significant success with RLF-100 at Houston Methodist Hospital (TrialSite wrote about this as well). TrialSite did what was possible, given its limitations as a non-medical information intermediary, to help this Texas-based family. The situation isn’t good, but one piece of promising news is that the U.S. Food and Drug Administration (FDA) recently announced that NeuroRx was granted a recently requested Investigational New Drug (IND) application to test RLF-100 (Aviptadil) for inhaled use in patients with moderate to severe COVID-19 in order to prevent progression to respiratory failure. This opens up new potential use cases for this investigational product that shows considerable promise against COVID-19.
Houston Methodist Hospital Success
The patient’s wife that contacted TrialSite heard that the drug was working on patients with severe COVID-19 conditions at Houston Methodist Hospital. TrialSite reported that doctors at this provider were identifying success treatment. For example, they reported that a 54-year-old had developed COVID-19 while being treated for rejection of double lung transplant and who came off a ventilator within four days. Other results were observed in over 15 patients under emergency use IND and an FDA expanded access protocol, which is open to patients too ill to be admitted to the ongoing Phase 2/3 trial. TrialSite advised the woman from San Antonio to check with the local hospital to determine if they could use the expanded access protocol. She was understandably upset her husband was at a purportedly “COVID”-designated hospital yet had no clinical trials. TrialSite wasn’t able to confirm or invalidate her assumptions, but again advised her to contact the physician team immediately with the new information (emergency access protocol).
Now with an approved IND, NeuroRx can get down to the business of hopefully saving more lives. This is the only life we have, and it’s not every day that a treatment comes along like this. But the drug must be put to the stronger test. In this Phase 2 clinical trial, patients with severe COVID-19 who have yet to develop respiratory failure are treated with nebulized RLF-100 (again Aviptadil is a synthetic version of Vasoactive Intestinal Polypeptide or VIP) 100 U3x daily plus the Standard of Care versus the placebo treatment plus the Standard of Care using an FDA 501(k) cleared mesh nebulizer.
As reported by the company in a recent press release, if the results of this first step are promising, the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the need for hospital admission. This opens up a very big market for NeuroRx and its Swiss partner.
The study team will assess the results based on the actual progression to severity of COVID-19 (i.e., does moderate progress to severe or critical or severe progressing to critical) over a 28 day period. Obviously, the less there is progression once on the study drug, the more powerful the results. Secondary outcomes include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.
The study is scheduled to run till October 2020 with final data reports on November 30, 2020.
Professor Jonathan Javitt, MD, MPH, CEO of NeuroRx, the U.S. partner of RELIEF, suggests that it is known now that “VIP suppresses replication of the SARS-CoV-2 virus in human lung cells based on the outstanding work of Oswaldo Cruz Institute (Rio de Janeiro).” Now the CEO is optimistic after success seen in Houston that this powerful investigational product will “stop the advancement of the virus in patients with earlier stages of COVID-19.”
Who is Relief Therapeutics Holdings AG (RELIEF)
Focus is an important thing in Life Sciences, and this Swiss-based group understands this important point. By focusing primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) but with a history of clinical testing and use in human patients or a strong scientific rationale, RELIEF establishes parameters to push forward and advance, while in parallel mitigate risks so ubiquitous in drug development.
Traded under the symbols RLF in SIX and RLFTF in the OTC, RELIEF is a Swiss-based publicly-traded drug development company focusing primarily on the clinical development of peptides and proteins of natural or engineered origin to address unmet medical needs.
The company was formed in 2016 when Relief Therapeutics SA merged with THERAMetrics Holding AG to accelerate the development of medicinal product candidates (MPCs) identified via a rigorous vetting and validation process.
One of their products in development, Aviptadil, is showing exciting promise in COVID-19 patients. It is an abundant biologically active endogenous human peptide that includes antiproliferative, anti-inflammatory, and immune-regulatory activities. As has been found, biological activity centers in the lungs and a vast body of experimental, pharmacological, and clinical data points lead researchers to believe the investigational product a candidate for the treatment of pulmonary sarcoidosis. COVID-19 opened up a new market need. With the partnership with NeuroRx in America, the pair launched two Phase 2 studies of Aviptadil in the treatment of ARDS associated with COVID-19.
For its last annual report (2019), the company introduced the promise of its COVID-19 research effort and pointed out its cash burn guidance for 2020 happens to be CHF 15 million. The company posits that to secure sufficient capital to complete COVID-19 studies it must do the following in parallel including 1) the sale of Sonnet Biotherapeutics shares, 2) the exercise of the Share Subscription Facility with an open credit line up to 43.8 million and 3) equity transactions with investors including their main investor Global Emerging Markets (GEM) which appears a committed investor. Of course, with the news lately, the stock price has shot upwards. Who stands to benefit inside? As mentioned, GEM(Global Yield Fund) owns 556,154,033 shares representing at the end of the year 26.8% of the outstanding stock. French neurobiologist Yves Sagot owns 8.2% of the shares; Swiss-based molecular biologist and former CEO Michael Dreano owns 6.6%; biotech consultant Gael Hedou owns 5.6% while other shareholders own 52.8%.
Chairman Selvaraju’s Statements Correct
RELIEF’s chairman Raghuram Selvaraju recently stated that the Swiss biotech could potentially generate hundreds of millions of dollars if Aviptadil is given the green light from regulators. Mr. Selvaraju is correct based on TrialSite’s own analysis. A top analyst has already forecast Gilead could earn between $1 to $3 billion with a commercial payer price point of just over $3,000. Given the total number of COVID-19 cases in the developed world, and if a vaccine takes more time to mature and the virus persists, and the product continues to work and can be used for outpatient (moderate cases to prevent hospitalization)—and assuming payer coverage (why wouldn’t they)—the turnover could certainly, under these assumptions, go into the hundreds of millions of dollars, and perhaps, if the drug cuts into Remdesivir territory and used as standard for even pre-moderate cases could achieve even more financially.
Unlike Remdesivir to date which has a moderate impact (reduce hospitalization for a few days but no evidence as of yet that COVID-19 death rate impacted), RLF-100, if it keeps producing results in the ongoing trials, and if it can be proven to materially save lives culminating with FDA and other agency approvals, then this investigational product will drive a return all concerned can feel good about.
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