Multi-variate analysis of LIVE-AIR Phase 3 data demonstrates that elevated baseline C-Reactive Protein ("CRP") is the most predictive feature for progression to invasive mechanical ventilation ("IMV") or death and may be a useful biomarker to guide therapeutic intervention
Patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo (p<0.001)
Findings suggest hospitalized COVID-19 patients who are early in the hyper-immune response, with lower baseline CRP levels (CRP<150 mg/l), achieve even greater clinical benefit from lenzilumab treatment
Humanigen, Inc. (Nasdaq:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, announced that a manuscript detailing the results of an analysis of CRP levels from the LIVE-AIR Phase 3 study is available on medRxiv (https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1) . The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.
Exclusive license from AstraZeneca adds a unique candidate and a broad library of compounds to Ovid’s franchise of potential first-in-class anti-epileptic therapies
Collaboration with Dr. Stephen Moss, founder of Tufts Laboratory for Basic and Translational Neuroscience Research, and expert team in neuropharmacology
Transaction is the first business development activity that seeks to enhance Ovid’s pipeline of small-molecule and genetic CNS medicines
Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today provided a regulatory update on the AT-007 Galactosemia program.
Following discussions with the FDA at the end of the year, the Company has decided to hold on submitting an NDA for AT-007 for treatment of Galactosemia pending additional discussions with the agency. Although the Galactosemia program had previously been discussed in the context of an NDA for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval.
The ongoing ACTION-Galactosemia Kids Phase 3 study is evaluating the impact of AT-007 treatment vs. placebo on clinical outcomes over time, including cognition, speech, behavior and motor skills. Clinical outcomes are assessed every 6 months by a firewalled committee. The first assessment will be completed in the first quarter of 2022, and then every 6 months thereafter until the study reaches statistical significance.
“While disappointed by this change in direction by the FDA, we remain committed to bringing this important treatment to patients with Galactosemia,” said Shoshana Shendelman, PhD, CEO, Founder and Chair of the Board of Applied Therapeutics. “We will continue to work with the FDA to determine the most expeditious path forward to regulatory approval and will provide an update on timing and plans accordingly.”
"In our previous guidance to investors, we advised that there were no filed patents protecting the manufacture of ZYESAMI. With the filing of this patent and the inventions described within, we at NRx believe we have a path to a long term commercial life for a stable and pharmaceutically active form of VIP as an innovative drug," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "Although, for obvious reasons, our initial focus has been the use of VIP in lung disease caused by COVID-19, we are now considering potential use of ZYESAMI in non COVID-related lung disease, liver disease, eye disease, and organ transplantation. We are deeply grateful to our partners at Nephron Pharmaceuticals for working with us and embracing the painstaking work required to bring a seventy-year-old dormant drug to life."
The Biden administration should direct the limited supply of Tamiflu-like COVID-19antiviral drugsto states like New York that have been hard hit by the Omicron variant, Sen. Chuck Schumer said Sunday.
“It’s a new weapon that we have to fight this Omicron COVID-19,” Schumer said of two new drugs recently approved by the FDA during a press briefing in Manhattan. “I’m calling on the federal government, which has bought all available [COVID] antivirals, to put New York at the top of the list as it distributes these.”
“We are number one in terms of the COVID cases, we are number one in terms of density, we are number on in terms of per capita, and so we deserve to get as many of these antivirals as quickly as possible,” he said. “The federal government should not distribute them across the board. They should look at where is the greatest need.”
Coronavirus cases have spiked in New York state and New York City in recent weeks. On Friday, 162,031 people tested positive for the virus statewide, according to the state Dept. of Health. Hospitalizations also increased with over one thousand patients in ICU.
Senate Majority Leader Chuck Schumer gave a press conference on January 2, 2021 over the ‘Tamiful” Antiviral for Covid.Kevin C. Downs for The New YorkSen Chuck Schumer urged President Biden to direct the pills to NYS and states where Omicron is surging so that they don’t potentially go unused.AP Photo/Carolyn Kaster
The Food and Drug Administration authorized Merck’s antiviral pill molnupiravir and Pfizer’s paxlovid late last month. The Pfizer drug is permitted for anyone over 12, while Merck’s product is currently for ages 18 and up.
Both drugs have been proven to reduce risk of hospitalization or death among COVID-19 patients — but both are in limited supply.
New York City residents who want the at-home treatments must do so through a pharmaceutical delivery service called Alto Pharmacy.
The Food and Drug Administration authorized Merck’s antiviral pill molnupiravir and Pfizer’s paxlovid late last month.Kevin C. Downs for The New York
Residents of other counties can find a list of participating pharmacies on the website of the state Dept. of Health.
New York City’s and state’s departments of health have reached a divisive and destructive low.In new guidelines rationing scarce, lifesaving oral antiviral medications and the one monoclonal antibody preparation that is effective against the Omicron variant of the SARS-CoV-2 virus that causes COVID-19, theyinstruct providers to “consider race and ethnicity”and give preference to those who are “Black, Indigenous, and People of Color.” These directives are immoral, illegal and bear no relation to the science.
The city’s Health Advisory #39 directs providers to adhere to the state Department of Health’s prioritization guidance for utilization of these COVID-19 treatments that are in short supply. It asks providers to consider whether patients are immunocompromised, their age, their vaccine status and the number of risk factors (medical conditions) they have for severe illness.
The problem with the state’s guidance is the instruction that “nonwhite race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.” Hence, all other risk factors such as age, immune, and vaccination status being equal, “nonwhite” and “Hispanic/Latino” patients will be granted superior treatment access compared with whites.
According to the guidelines, “nonwhite race or Hispanic/Latino ethnicity” should be considered a risk factor and given preference for COVID-19 treatments.Photo by HANDOUT/Pfizer/AFP via Getty Images
Far and away the most significant factor associated with severe COVID-19 disease and death is age. Taking the 18-39 age group as a reference (Risk Ratio of 1), the risk of death doubles for the 40-49 age group (RR=2.2), doubles again in the 50-64 group (RR=4.3), and reaches an RR of 6.7 for those 65-74. The RR tops out for those 85 and older at 10.6.
Minority populations are younger than the white population. But they suffer from more of the underlying medical conditions that are associated with severe COVID-19 illness.
These include: obesity, diabetes with complications and chronic kidney disease. The risk increases with more conditions.
While it is possible that “longstanding systemic health and social inequities” could lead to an increased incidence of these conditions in minority communities, race and minority status do not, on their own, lead to more severe COVID-19 disease. If discrimination causes one the medical conditions, the condition itself should be counted in drug-distribution decisions. Crediting minority status and the medical condition is double counting. And counting minority status as a risk factor, when there is no resulting medical condition, is unfair and unwarranted.
Discrimination on the basis of race must meet the legal standard of strict scrutiny — the government must demonstrate its action addresses a compelling interest and is narrowly tailored to achieve that interest. Arguably, New York has an important interest in assuring that the limited supply of COVID-19 medications is allocated to maximize medical benefit. But New York’s guidelines are not even reasonably or rationally related toward achieving that end. They may direct the medicines toward minority patients and away from sicker, more vulnerable white patients who would benefit more.
This sort of discriminatory, politically correct decision-making should not be tolerated. New York health-department bureaucrats should revise these guidelines immediately or risk having them struck down in court.
Joel Zinberg, MD, is a senior fellow at the Competitive Enterprise Institute, an associate clinical professor of surgery at the Icahn School of Medicine at Mount Sinai in Manhattan and the director of Paragon Health Institute’s Public Health and American Well-being Initiative.
New York City MayorEric Adamssaid on Sunday that he is mulling a COVID-19 booster mandate for city employees.
During an appearance on ABC's "This Week," Adams, who was sworn in as mayor on Saturday, said the city would “examine the numbers” and decide if the mandate was needed.
"If we feel we have to get to the place of making that mandatory, we’re willing to do that, but we’re encouraging them to do that now," the mayor also said, noting that he is boosted.
As the city of New York grapples with skyrocketing COVID-19 case numbers, the new mayor remains insistent that the city must stay open.
"If we close down our city, it is as dangerous as COVID," Adams added. "That's what our focus must be. So that proper balance of safety [and] keeping our economy operated is going to allow us to get through."
Shortly after Adams took office, he used his inaugural address to assure New Yorkers that the city would not be controlled by the ongoing pandemic.
“This will be our New Year's resolution: We will not be controlled by crises,” he said.
New York City has seen a daily case average of 23,943 in the last seven days, according to data from the city's health department. The state also reported 62,536 positive tests on Saturday as the highly contagious omicron variant continues to sweep the country.
