NeuroRx has submitted a request for an Emergency Use Authorization (EUA) with the FDA for the use of RLF-100 aviptadil in patients who are receiving intensive care and have exhausted all approved treatments.
RLF-100 is being developed by NeuroRx as part of a global partnership with Relief Therapeutics (OTCQB:RLFTF).
NAI500 seeks to provide the most pressing investment knowledge to its readers. On October 7 and 8, NAI500 is hosting a FREE VIRTUAL EVENT focusing on the rapidly growing mining sector. Learn about Gold and Precious Metals Exploration, Battery Metals and much more by registering here.
RLF-100 (Aviptadil) is a synthetic form of the human Vasoactive Intestinal Peptide which reduces inflammation in the lungs and protects the alveolar type II cells.
In an interview on CNBC today, HHS Secretary Alex Azar stated that the pivotal Phase 3 study in the U.S. evaluating the safety and immunogenicity of AstraZeneca’s (AZN +1.7%) COVID-19 vaccine candidate AZD1222 remains on hold while federal investigators seek “answers to important questions” regarding its safety.
The study was paused on September 6 after a subject in the U.K. experienced a serious adverse reaction after inoculation.
The feds are taking time to thoroughly investigate the event amidst concerns among Americans that fast-tracked vaccines may not be subject to the requisite rigor to ensure their safety and efficacy.
“The president’s made it clear, I’ve made it clear, the FDA commissioner has made it clear, and the CEOs of the relevant companies have made it clear — this is going to be by the book based on science, data and the law,” Azar told CNBC.
COVID-19 vaccine developer Inovio Pharmaceuticals (INO -9.6%) slumps on average volume in apparent response to a post on social media by short seller Citron Research that the stock is heading back to $5 a share, 68% below the current price of $15.47.
Shares peaked at $33.79 on June 26 during the COVID-19 vaccine-stoked rally.
Roth Capital is another bear, believing the candidate INO-4800 has “virtually no chance” of coming out on top of its many competitors.
Muddy Waters is yet another pessimist.
The Financial Times reports that the U.K. will host the world’s first human COVID-19 challenge trials, in which healthy volunteers are deliberately infected with coronavirus, in order to evaluate the effectiveness of experimental vaccines.
The government-funded studies should launch in January 2021 at a 24-bed secure quarantine facility in east London.
About 2,000 potential U.K. volunteers have signed up through an advocacy group called 1Day Sooner which campaigns for COVID-19 infection trials aimed at accelerating development which are most useful when the viral infection rate is low. About 37K people globally have enlisted.
The group is launching a campaign this week to petition parliament for funds for a biocontainment facility with sufficient capacity to quarantine up to 200 people.
Volunteers will receive up to £3,750 for participating but may earn more considering the length of isolation, potentially as long as a month.
One key aspect of the studies is to select and purify a strain of the coronavirus that generally represents the SARS-CoV-2 strain currently circulating in the overall population.
Also, investigators will have a rescue remedy on hand to prevent serious illness in subjects. The London trial will initially use Gilead Sciences’ (GILD +0.3%) Veklury (remdesivir).
In the U.S., NIH has awarded a $3.6M contract to Colorado State University to support the manufacture of two coronavirus strains that could be used in challenge studies. NIH is currently investigating the technical and ethical aspects for such trials.
Selected tickers: Johnson & Johnson (JNJ +1.0%), Moderna (MRNA -3.3%), Pfizer (PFE -0.1%), BioNTech SE (BNTX -3.6%), Sanofi (SNY +1.4%), GlaxoSmithKline (GSK +1.0%), AstraZeneca (AZN +1.4%)
Johnson & Johnson (NYSE:JNJ) initiates a 60K-subject Phase 3 clinical trial, ENSEMBLE, evaluating the safety and immunogenicity of its single-shot COVID-19 vaccine candidate Ad26.COV2.S (JNJ-78436735).
The study will enroll participants at least 18 years old, with a significant percentage of people over the age of 60, including people with and without comorbidities associated with increased risk for progression to severe COVID-19. Trial sites are located in the U.S., Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
The primary efficacy endpoint is the number of participants with first occurrence of confirmed moderate-to-severe/critical COVID-19 with seronegative status up to 2.1 years. Moderate disease is defined as one sign and one symptom (e.g., shortness of breath or cough) or two symptoms from the FDA’s list in its guidance document.
The estimated completion date is March 2023.
According to CSO Paul Stoffels, the company might be able to determine safety and efficacy by year-end.
In parallel, JNJ has agreed in principle to collaborate with the UK government on a separate Phase 3 in multiple countries to investigate a two-dose vaccine candidate.
Shares up 2% premarket on light volume.
SA Authors are Bullish.
