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Tuesday, August 3, 2021

Big Rock Partners Acquisition Corp (NASDAQ: BRPA) SPAC Heats Up as NeuroRx. (NRXP) Reports ZYESAMI™ Met Primary Endpoint in its Covid-19 Phase 2b/3 Trial

Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is making an explosive move up the charts after its coming merger partner  NeuroRx reported ZYESAMI™ 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. This is big news for BRPA which took off in December after the Company initially announced the merger with NeuroRx. Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021.  

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. In this group, ZYESAMI™ 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).  Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007). ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA). 

Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is a blank check company formed pursuant to the laws of the State of Delaware on September 18, 2017 for the purpose of entering into a merger, stock exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities. BRPA is a clean shell with $32,005,205 held in cash and marketable securities held in money market funds, which are invested in U.S. Treasury securities. During 2020 BRPA reported $1.2 million in interest income and $400k in net income. 

BRPA skyrocketed off its $10 base in December to a high of $76.99 per share after the Company reported it was merging with NeuroRx, Inc. currently developing the covid therapeutic (RLF-100 or “ZYESAMI™ (aviptadil)”). Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021.  

An Innovator in Mental Health and Respiratory Drug Development; NeuroRx is a clinical stage, small molecule pharmaceutical company which develops novel therapeutics for the treatment of central nervous system disorders and life-threatening pulmonary disease. NeuroRx’s two main drugs are “ZYESAMI™ (aviptadil)” which is an application for COVID-related respiratory failure and “NRX-101”, which focuses on suicidal bipolar depression and PTSD. ZYESAMI is a synthetic human Vasoactive Intestinal Peptide (VIP), a 28 amino-acid natural peptide with 50 years of research evidence led by the late Prof. Sami Said, documenting protection from Lung Injury by protecting type II epithelial cells. NRX-101 is a fixed-dose combination of D-cycloserine and lurasidone that has advanced to phase 3 with FDA Breakthrough Therapy Designation, a Special Protocol Agreement, Biomarker Letter of Support, and Fast Track Designation. NRX-100/101 is being developed based on Prof. Daniel Javitt’s (Chair of NeuroRx’s Scientific Advisory Board) patented discovery that drugs targeting both the NMDA and 5-HT2A receptors in the brain have the potential to treat both depression and suicidality without the hallucinations caused by most NMDA inhibitors and without the potential for suicide attributable to other 5-HT2A inhibitor drugs. 

NeuroRx’s management team is comprised of seasoned industry veterans, led by Founder, Chairman & CEO Jonathan C. Javitt, MD, MPH, Robert Besthof, MIM (Chief Commercial Officer), William Fricker, MBA, CPA (Chief Financial Officer) and Alessandra Daigneault, JD (Corporate Secretary), who are expected to continue to run the combined company, post-transaction. 

BRPA is once again on fire after NeuroRx reported ZYESAMI™ 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. 

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. In this group, ZYESAMI™ 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).  Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007). 

To the company’s knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA). 

Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs. 

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NeuroRx has announced the commencement of a clinical trial of inhaled ZYESAMI™ for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure. NeuroRx has also announced the inclusion of inhaled ZYESAMI™ in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure. The company has signed a clinical trial participation agreement with the National Institutes of Health. 

The study’s coordinating committee, including Professors Dushyantha Jayaweera, MD, FACP (University of Miami), Richard Lee, MD, (UC Irvine), and J. Georges Youssef, MD (Houston Methodist Hospital) commented, “The 60-day observation framework implemented last month by FDA for critically ill patients with COVID-19 is more consistent with the clinical course of this lethal disease than the 28-day time frame originally adapted from other conditions that cause respiratory distress. The association of baseline oxygenation status (high flow nasal oxygen vs. ventilation) is not surprising in that patients who require mechanical or noninvasive ventilation in order to maintain blood oxygen are likely to have substantially more damage to the lining of their lungs compared to patients whose blood oxygen level can be maintained with high-flow oxygen delivered to the nose. The finding that patients fared substantially better in tertiary care centers as compared to regional hospitals may be influenced by the intensity of the public health crisis at the regional hospitals that participated in the study, all of which were operating at 200% or higher overcapacity in their intensive care units with implementation of temporary ICU beds and shortages of critical care staff.” 

Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, “ZYESAMI has now demonstrated itself in a phase 2/3 trial, conducted under FDA Fast Track Designation, not only to shorten hospitalization (as was previously reported) but also to save lives and increase the likelihood of patients returning safely home to their families. In exactly 12 months, a lifesaving drug has advanced from concept to clinical success in partnership with Relief Therapeutics in the midst of a public health emergency that has claimed the lives of millions. Today’s findings confirm the often-dramatic clinical success that has been seen in numerous patients treated in the US and abroad under emergency use protocols. We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible.” 

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Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is making an explosive move up the charts after its coming merger partner  NeuroRx reported ZYESAMI™ 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. This is big news for BRPA which took off in December after the Company initially announced the merger with NeuroRx. Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021. 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. In this group, ZYESAMI™ 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).  Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007). ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA). We will be updating on BRPA on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with BRPA.

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Disclosure: we hold no position in BRPA either long or short and we have not been compensated for this article.

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