Connect with us

Economics

NRx Pharmaceuticals Announces Data Safety Monitoring Board (DSMB) Update on U.S. National Institutes of Health (NIH) Study of ZYESAMI® (aviptadil) in Critical COVID-19

NRx Pharmaceuticals Announces Data Safety Monitoring Board (DSMB) Update on U.S. National Institutes of Health (NIH) Study of ZYESAMI® (aviptadil) in Critical COVID-19
PR Newswire
RADNOR, Pa., May 25, 2022

Based on a review of nearly 75% of the tar…

Published

on

NRx Pharmaceuticals Announces Data Safety Monitoring Board (DSMB) Update on U.S. National Institutes of Health (NIH) Study of ZYESAMI® (aviptadil) in Critical COVID-19

PR Newswire

  • Based on a review of nearly 75% of the target enrollment of 640 patients, most of which have reached 90 days, the Independent DSMB overseeing the ACTIV-3b (TESICO) study determined that evaluation of aviptadil should cease due to futility
  • ZYESAMI® (aviptadil) was the sole remaining investigational medicine in ACTIV-3b targeted at Critical COVID-19 patients
  • ACTIV-3b Critical Care Study evaluated ZYESAMI and Veklury® (remdesivir), in Critical COVID-19 Patients, as monotherapy and in combination against placebo
  • The DSMB stated there were no safety concerns for aviptadil

RADNOR, Pa., May 25, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals"), a clinical-stage biopharmaceutical company, today announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. The DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The DSMB recommended stopping further randomization to aviptadil due to aviptadil not meeting the futility guidelines outlined by the pre-approved analytical plan. The primary endpoint (90 day 6-category ordinal score) was not supportive (OR 1.10; 0.79 – 1.54; p=0.56), and 90-day mortality secondary endpoint was also not supportive with 37% mortality in the aviptadil group vs 36% in the placebo group; HR 1.04 (0.77-1.41); p=0.79.   There were no safety concerns, the known side effects of aviptadil (principally diarrhea and hypotension) were managed well with the protocols in place.

"We thank the NIH and the Trial Leadership for its extensive work in studying ZYESAMI® (aviptadil).  We will continue to work closely with them to better understand the data over the coming months.  This will also enable us to evaluate the options for ZYESAMI® in protecting the lung in other respiratory disorders, as well as its potential in other therapeutic areas," said Robert Besthof, Interim CEO of NRx Pharmaceuticals.  "Critical COVID-19 remains a very high unmet need associated with significant mortality. " 

"Our corporate focus remains to apply innovative science to known molecules in order to address very high unmet needs.  We have a flexible infrastructure that allows us to focus our resources on our Breakthrough Therapy designation drug NRX-101.  We are already actively enrolling patients in our Phase II study for bipolar depression in patients with Sub-acute Suicidal Ideation & Behavior (SSIB) and in the second half of the year we intend to start our Phase IIb/III registrational study for Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB). "

About NRx Pharmaceuticals

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company") draws upon decades of collective, scientific, and drug-development experience to bring improved health to patients. The U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy designation, a Special Protocol Agreement, and a Biomarker Letter of Support for NRX-101, an investigational medicine for the treatment of severe bipolar depression in patients with acute suicidal ideation and behavior after initial stabilization with ketamine or other effective therapy. In addition, ZYESAMI® (aviptadil), for patients with COVID-19, has been granted Fast Track designation by the FDA and until recently, was enrolling in a Phase III trial for Critical COVID-19 patients which is sponsored and managed by the U.S. National Institutes of Health.

NRx Pharmaceuticals is led by executives who have held senior leadership roles at Lilly, Pfizer, and Novartis as well as major investment banking institutions.

Cautionary Note Regarding Forward-Looking Statements

This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company's management.  

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.  Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

CORPORATE CONTACT
Molly Cogan
Sr. Director, Global Communications 
mcogan@nrxpharma.com

INVESTOR RELATIONS
Tim McCarthy
Investor Relations
tim@lifesciadvisors.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-data-safety-monitoring-board-dsmb-update-on-us-national-institutes-of-health-nih-study-of-zyesami-aviptadil-in-critical-covid-19-301555549.html

SOURCE NRx Pharmaceuticals, Inc.

Read More

Continue Reading

Economics

The One Housing Chart That Shows A ‘Buyer’s Market’ Has Returned

The One Housing Chart That Shows A ‘Buyer’s Market’ Has Returned

The red hot pandemic-era housing market is cooling as historically tight…

Published

on

The One Housing Chart That Shows A 'Buyer's Market' Has Returned

The red hot pandemic-era housing market is cooling as historically tight available inventory shows signs of reversing. 

An affordability crisis has removed millions of new home buyers as the number of active US listings soared 18.7% in June from a year earlier, the most significant increase in Realtor.com's data going back to 2017, according to Bloomberg. The days of insane bidding wars, waiving home inspections, and putting in an offer 20% or more over the list price appear to be over. In other words, a buyer's market could be emerging. 

"While we anticipate that more inventory will eventually cool the feverish pace of competition, the typical buyer has yet to see meaningful relief from quick-selling homes and record-high asking prices," said Danielle Hale, chief economist for Realtor.com. 

Austin, Texas; Phoenix, Arizona; and Raleigh, North Carolina saw active listings more than double from a year ago. Nashville, Tennessee, active listings jumped 86%, and 72% in the Riverside, California. 

The Federal Reserve's most aggressive tightening campaign sent the 30-year fixed-loan mortgage rate from 3% to over 6% this year (back in March, we warned coming rate explosion would trigger a housing affordability crisis), removing millions of new home buyers who can't afford the cost of homeownership as the median existing-home sales price was around $407k in May. 

Even though inventory is historically tight, supply is expected to increase in markets across the country as demand for loan applications among prospective buyers slumps. Fewer buyers equal more inventory. 

The takeaway is that inventory is rising as homes stay on the market longer because demand evaporated thanks to the housing affordability crisis -- this could mean a housing top is nearing. 

Tyler Durden Thu, 06/30/2022 - 18:50

Read More

Continue Reading

Economics

States Need To Avoid ‘Cures’ That Can Make Inflation Worse

States Need To Avoid ‘Cures’ That Can Make Inflation Worse

Authored by Regina M. Egea and Danielle Zanzalari via RealClearPolicy.com,

Across…

Published

on

States Need To Avoid 'Cures' That Can Make Inflation Worse

Authored by Regina M. Egea and Danielle Zanzalari via RealClearPolicy.com,

Across the United States, state governments are awash in cash. In a sharp contrast, American taxpayers are enduring a rate of inflation unseen in four decades, with the costs of everything from food to gasoline at record highs.

In our home state of New Jersey, Trenton is looking at an unprecedented surplus of $8 billion through a combination of increased tax revenue, federal pandemic aid and borrowing.

A natural impulse among residents and policymakers is to offer residents “relief” in the form of rebate checks.

The reality is that relying exclusively on rebates or direct cash transfers to individuals will only lead to more inflation as this puts more money in consumers’ hands exacerbating the same problem as today - too many dollars chasing too few goods.

Rather, it is prudent that states focus on long-term investment and responsible budgeting to ensure economic growth now and in the future. This is especially important in high tax, big spending states due to the greater flexibility in work arrangements that have exposed the reality that wealth is mobile.

With more residents fleeing high tax states to low tax states, states will need to reevaluate their tax and regulatory climate to stay competitive. 

Regulation can raise the costs for consumers and slow job growth. A series of studies shows the regulation raises prices and worsens poverty.

Working with local governments to revisit restrictive laws that contribute to higher housing prices, such as building height restrictions and zoning rules, as well as removing unnecessary restrictions on business operations will lead to more economic growth.

Another way states can aid productivity and long-term economic growth with their temporary budget surplus, is to fund training programs for middle-skilled jobs.

Nearly every industry has experienced labor shortages and that reality is especially acute in trades like auto, refrigeration, HVAC, electrical, welding, and manufacturing.

States can invest in these skills through high school and vocational school programs. With college borrowing costs astronomically high, this encourages individuals to pursue careers that are lucrative and budget friendly, as well as fill the over 75,000 job openings that our state of New Jersey is projected to need in just a few years.

To further long-term economic growth many states should also concentrate on fixing their unfunded pension liabilities for public employees. This impacts red and blue states alike, with massive liabilities in California ($1.53 trillion), Illinois ($533.72 billion), Texas ($529.70 billion), New York ($508.70 billion) and Ohio ($429.53 billion). Here in New Jersey, our liability is nearly $40,000 for every resident of the state, which can dramatically deter future growth. Beyond using some of states’ budget surplus to shore up pension liabilities, states should move public employees to defined contribution plans, which are used by more than 100 million Americans. These are found to have better investment returns than state-wide pension plans and cost taxpayers less.

Our final recommendation is perhaps our most important: Save for a rainy day. If the U.S. economy enters into a recession, this will mean fewer jobs and less tax revenue for states. To prepare for the future when states again face a budget shortfall, which may be sooner than we think, states should follow best practices of reserving 10% of their budget in a rainy day fund, to sustain essential programs should a downturn occur in the future.

As state leaders consider their budgets, they should focus on long-term economic growth initiatives. Proposals like funding middle-skilled job trainings ensure workers are ready for the next decade, whereas eliminating unnecessary regulations and focusing on pro-growth tax reforms encourages residents to build businesses and create jobs. Lastly, taking care of state finances by properly funding state employees’ retirement plans and saving for a rainy day will ensure that no state is left behind in the next economic downturn.

Tyler Durden Thu, 06/30/2022 - 17:50

Read More

Continue Reading

Spread & Containment

Aging-US | Time makes histone H3 modifications drift in mouse liver

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone…

Published

on

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone H3 modifications drift in mouse liver.”

Credit: Hillje et al.

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone H3 modifications drift in mouse liver.”

Aging is known to involve epigenetic histone modifications, which are associated with transcriptional changes, occurring throughout the entire lifespan of an individual.

“So far, no study discloses any drift of histone marks in mammals which is time-dependent or influenced by pro-longevity caloric restriction treatment.”

To detect the epigenetic drift of time passing, researchers—from Istituto di Ricovero e Cura a Carattere Scientifico, University of Urbino ‘Carlo Bo’, University of Milan, and University of Padua—determined the genome-wide distributions of mono- and tri-methylated lysine 4 and acetylated and tri-methylated lysine 27 of histone H3 in the livers of healthy 3, 6 and 12 months old C57BL/6 mice. 

“In this study, we used chromatin immunoprecipitation sequencing technology to acquire 108 high-resolution profiles of H3K4me3, H3K4me1, H3K27me3 and H3K27ac from the livers of mice aged between 3 months and 12 months and fed 30% caloric restriction diet (CR) or standard diet (SD).”

The comparison of different age profiles of histone H3 marks revealed global redistribution of histone H3 modifications with time, in particular in intergenic regions and near transcription start sites, as well as altered correlation between the profiles of different histone modifications. Moreover, feeding mice with caloric restriction diet, a treatment known to retard aging, reduced the extent of changes occurring during the first year of life in these genomic regions.

“In conclusion, while our data do not establish that the observed changes in H3 modification are causally involved in aging, they indicate age, buffered by caloric restriction, releases the histone H3 marking process of transcriptional suppression in gene desert regions of mouse liver genome most of which remain to be functionally understood.”

DOI: https://doi.org/10.18632/aging.204107 

Corresponding Author: Marco Giorgio – marco.giorgio@unipd.it 

Keywords: epigenetics, aging, histones, ChIP-seq, diet

Sign up for free Altmetric alerts about this article:  https://aging.altmetric.com/details/email_updates?id=10.18632%2Faging.204107

About Aging-US:

Launched in 2009, Aging (Aging-US) publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways.

Follow Aging on social media: 

  • SoundCloud – https://soundcloud.com/Aging-Us
  • Facebook – https://www.facebook.com/AgingUS/
  • Twitter – https://twitter.com/AgingJrnl
  • Instagram – https://www.instagram.com/agingjrnl/
  • YouTube – https://www.youtube.com/agingus​
  • LinkedIn – https://www.linkedin.com/company/aging/
  • Pinterest – https://www.pinterest.com/AgingUS/

For media inquiries, please contact media@impactjournals.com.

Aging (Aging-US) Journal Office
6666 E. Quaker Str., Suite 1B
Orchard Park, NY 14127
Phone: 1-800-922-0957, option 1

###


Read More

Continue Reading

Trending