Biogen announced that its mid-stage monoclonal antibody, litifilimab, is showing promise in reducing joint pain related to systemic lupus erythematosus (SLE) lupus.
Data from the two-part Phase II LILAC study highlighting the efficacy of litifilimab in lupus patients was published in The New England Journalof Medicine. Data from Part A of the LILAC study showed that after 24 weeks of treatment with litifilimab, SLE patients reported a reduction in the total number of swollen and tender joints compared to placebo.
Litifilimab, a humanized IgG1 monoclonal antibody targeting blood dendritic cell antigens (BDCA2), significantly reduced disease activity in people with SLE based on active joint count compared to placebo. SLE is associated with multiple symptoms, including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis and seizures.
Through its ability to bind to BDCA2, litifilimab has been shown to reduce pro-inflammatory molecules that are expressed on plasmacytoid dendritic cells, including type 1 interferons. This inflammation is thought to play a significant role in lupus.
The Phase II trial was not powered to assess secondary endpoints.
Litifilimab was well-tolerated, with most adverse events considered mild or moderate. However, there is concern the monoclonal antibody could be related to the development of shingles, according to a report in Medical Xpress.
SLE causes chronic inflammation, pain and organ damage in afflicted patients. Treatment options for this form of lupus are limited, and the disease predominantly affects women and people of color who have been underrepresented in clinical research.
Last year, the FDA approved AstraZeneca's Saphnelo for SLE. Saphnelo targets interferon 1, like litifilimab.
Biogen is currently enrolling patients with active SLE into two global Phase III studies: TOPAZ-1 and TOPAZ-2. It plans to initiate a pivotal study in cutaneous lupus erythematosus later this year.
SLE predominantly affects women and people of color. To that end, the company said enrollment targets have been set to "achieve appropriate representation of the African American and Hispanic/Latino communities."
The most recent report follows a previous publication in NEJM that highlighted positive results from Part B of LILAC evaluating litifilimab in cutaneous lupus erythematosus (CLE). Biogen noted that both publications illustrate significant evidence that supports the continued development of litifilimab in lupus.
In both parts of the study, the primary endpoints were met, with litifilimab demonstrating superior efficacy to placebo. Litifilimab demonstrated efficacy in reducing total active joint count and improving skin disease activity in participants with SLE and CLE, respectively.
Nathalie Franchimont, head of Biogen's multiple sclerosis and immunology development unit, noted that this second NEJM publication demonstrates the "totality of data" from the Phase II LILAC study. The data reinforces the company's belief in the potential of litifilimab as a first-in-class therapy for systemic and cutaneous lupus.
The federal class action lawsuit says the city has violated the Americans with Disabilities Act by allowing homeless people’s tents to block city sidewalks, making it difficult for people using wheelchairs, walkers or canes to use them.
“The entire class of persons with disabilities are regularly deprived of the benefits of services of the city of Portland,” said John DiLorenzo, lead counsel for the plaintiffs.
The suit was filed Tuesday in U.S. District Court in Portland.
The plaintiffs include nine people with disabilities and a caretaker. Among the plaintiffs is Keith Martin, a 71-year-old Portland resident who has used a wheelchair since having a stroke three years ago.
“I couldn’t get to my breakfast in the morning because there was a tent covering the whole sidewalk,” Martin said. “I was forced onto the street and narrowly missed a streetcar that came around the corner.”
Oregon’s homelessness crisis has been fueled by a housing shortage, the coronavirus pandemic and high drug addiction rates. Federal data from the latest National Survey on Drug Use and Health found that 9% of teens and adults in Oregon had illicit drug use disorders in 2020. That year, the state also ranked last in access to drug addiction treatment, according to the survey.
The class action suit seeks to require the city to clear all sidewalks of tent encampments and debris, and to “construct, purchase, or otherwise provide for emergency shelters in which to house the unsheltered persons” who may be affected.
Such measures would make sidewalks accessible for people with disabilities in a safe manner while providing a safe place for unhoused people, DiLorenzo said.
Portland Mayor Ted Wheeler’s office said the mayor is meeting with the city attorney before providing comment.
About 13% of Portlanders live with a disability, according to the lawsuit, including 6% with mobility impairments and 2.4% with visual impairments.
Plaintiff Steve Jackson, 47, is legally blind and uses a cane to walk. He said tents prevent him from navigating the sidewalk and accessing bus stops.
“Often there’s tents blocking the entire sidewalk, where I don’t see them because they weren’t there the day before, and I hit the tent and then people are mad at me and think I’m attacking them,” Jackson said during a news conference.
There were about 3,000 unsheltered people living in Multnomah County, home to Portland, during the most recent point-in-time count in January 2022, county figures show.
The Portland City Council declared a state of emergency on homelessness in 2015 and has extended it five times since then. The measure, now set to expire in 2025, reduces the bureaucratic hurdles surrounding the creation of homeless shelters.
Despite the city’s years-long emergency measure, the estimated number of people experiencing homelessness spiked 25% in the Portland area between 2020 and 2022, according to point-in-time counts reported to the U.S. Department of Housing and Urban Development.
This year alone, Wheeler has issued four emergency declarations to address homelessness issues. Most recently in August, he expanded a previous declaration that prohibits camping along high-speed corridors such as highways to include key walking routes to K-12 schools.
The state has wrestled with a debate over the best way to reduce homelessness. Some business groups have called for more encampment sweeps and stricter enforcement of anti-camping ordinances, while others want more investment in social services and affordable housing.
Oregon lawmakers earlier this year approved a budget that includes $400 million to address homelessness and housing.
Gov. Kathy Hochul had New Yorkers pay twice as much for COVID tests from a company tied to nearly $300,000 in donations to her campaign compared to other state vendors, a new report details, raising fresh concerns ofalleged pay-to-play behaviorahead of the Nov. 8 election.
“Whether it was pay-to-play or total incompetence – New York taxpayers and then the federal taxpayers got massively ripped off,” John Kaehny, of the good-government group Reinvent Albany, said of the Digital Gadgets deal funded by New York taxpayers with the help of federal relief aid.
While some companies charged the state just $5 for rapid tests, the N.J.-based Digital Gadgets got as much as $13 per unit in a total of $637 million worth of no-bid deals for millions of tests as Hochul pushed schools to stay open amid the omicron wave last year, according to the Times Union
The deal was made under suspended procurement rules enabled by a state of emergency that Hochul has renewed every month since late last year.
Some Republicans are now calling for Hochul to come clean about the questionable purchases.
“At the very least, the public deserves a hearing to address how this deal was arranged, why it lacked a formal contract, and the seemingly questionable timing of relevant communications,” Republican Assembly Minority Leader William Barclay said in a statement Friday.
Government watchdogs say the test purchases stick out even compared to other alleged instances of her administration helping donors tied to causes as diverse as rapid tests, the Medicaid transportation services, and overhauling Manhattan’s Penn Station.
Hochul raised eyebrowsfor backing a Penn Station overhaul that would potentially direct more than $1 billion in tax breaks to Vornado Realty Trust after its head, Steve Roth, gave the maximum $68,700 to her campaign in December.
A company called Medical Answering Services has landed millions in state Medicaid business under Hochul’s watch after its president and his wife gave $52,600 stretching back to last September when she was still lieutenant governor under Cuomo.
Hochul also got slammed for backing $600 million in public money for a new stadium for the Buffalo Bills, who do business with a company employing her husband Bill Hochul, who has officially recused himself from the matter.
“This deal looks to be the dirtiest,” Kaehny said of the business Hochul did with Digital Gadgets on rapid tests in late 2021 and early 2022.
The incumbent Democrat – who has raised more than $34 million in campaign cash at a rapid rate over the past year – has denied that campaign cash has anything to do with official decision-making on government contracts.
New Jersey-based Digital Gadgets founder and CEO, Charlie Tebele charged $13 per COVID test, a total worth of $637 million of no-bid deals.charlietebel/linkedin
“At a time when at-home tests were nearly impossible to find in stores and the Omicron variant caused a spike in COVID-19 cases, state agencies worked diligently to secure a large number of tests to allow kids across New York to safely return to in-person learning and protect residents and visitors in nursing homes,” Hochul spokesman Avi Small said in a statement.
A campaign spokesman told The Post Friday that “high ethical standards” mean donors have “no influence” over government decision-making despite concerns about the timing of the Digital Gadgets deal.
The company offered to sell the state rapid tests last December shortly after Hochul declared a state of emergency suspending purchasing rules requiring state Comptroller Thomas DiNapoli to sign off before state contracts get finalized.
It remains unclear to what extent the Hochul administration sought to negotiate down the price for 52 million tests delivered on time through two purchase orders that charged $13 and $11.50 per unit, according to documents obtained by the Times Union.
Two other companies charged the state at least several dollars less per unit though the administration has claimed those bought through Digital Gadgets are of a higher quality than those offered by other companies, which could only provide a limited volume in time for the reopening of schools amid the omicron wave.
“Because of the reliability of the tests themselves and the assurances around delivery, comparing US-made AccessBio tests to inferior quality tests that were manufactured in China is not valid,” John Gallagher, a spokesman for Digital Gadgets, said in a statement.
A campaign spokesman told The Post Friday that “high ethical standards” mean donors have “no influence” over government decision-making.Matthew McDermott
The Department of Health paid Digital Gadgets on Dec. 29, 2021, and March 25, 2022, for the tests, which were being distributed throughout the winter and spring, according to a DOH spokesman, who added that no new orders were made after January.
Company honcho Charlie Tebele – whose family has given roughly $300,000 to Hochul’s campaign – and his wife gave the maximum $69,700 each to her run for governor in May, state records show.
With COVID-19 caseloads steadily dropping since then, the state still has about 7 million tests bought through Digital Gadgets slated to be distributed through the end of the year, according to the Times Union.
“They way over-bought at a very high price – using these emergency powers – from a major donor. I mean, it’s just – the whole thing looks very bad,” said Bill Hammond, a senior health care fellow at the Empire Center for Public Policy.
The suspect pay-to-play situations are transforming Hochul’s prolific fundraising into a political liability in her race against Republican Rep. Lee Zeldin, whose mid-July campaign filings show he had $1.57 million on hand compared to $11.7 million for Hochul.
The GOP standard-bearer has campaigned heavily on the notion that Hochul sold out to campaign donors after replacing disgraced ex-Gov. Andrew Cuomo last August following his resignation amid a multitude of sex-harassment and COVID-handling scandals.
“Kathy Hochul loves declaring health emergencies, because that’s how she hoards extra self-claimed powers that allow her to award MASSIVE no-bid, ridiculously priced government contracts to her top campaign donors, going around the state’s competitive bidding laws,” Zeldin tweeted Friday afternoon about the Digital Gadgets deal.
Gallagher said Tebele “never” spoke to Hochul about anything related to COVID-19 tests while claiming the seemingly outlandish price was fair to taxpayers given the timing of the deals.
“Digital Gadgets provided 52 million high-quality AccessBio tests at a price that was very competitive at the time, and because the tests were manufactured in New Jersey, were able to provide a level of certainty around delivery and shipping that the State needed,” Gallagher said in the statement.
By the time you test positive for COVID-19, the SARS-CoV-2 virus has already taken up residence in your respiratory system. With each breath, you expel invisible viral particles into the air—a process known as viral shedding. Existing drugs aimed at treating COVID-19, even when they address symptoms of the virus, do little to quell viral shedding.
Researchers at Gladstone Institutes previously developeda novel approachfor treatinginfectious diseases: a single-dose, intranasal treatment that protects against severe SARS-CoV-2 infection.
In a new study published in Proceedings of the National Academy of Sciences, they show that this new treatment, called a therapeutic interfering particle (TIP), also decreases the amount of virus shed from infected animals and limits transmission of the virus.
"Historically, it has been exceptionally challenging for antivirals and vaccines to limit the transmission of respiratory viruses, including SARS-CoV-2," says Gladstone Senior Investigator Leor Weinberger, Ph.D., senior author of the new paper. "This study shows that a single, intranasal dose of TIPs reduces the amount of virus transmitted, and protects animals that came into contact with that treated animal."
"To our knowledge, this is the only single-dose antiviral that reduces not only symptoms and severity of COVID-19, but also shedding of the virus," says Sonali Chaturvedi, Ph.D., a research investigator at Gladstone and first author of the paper.
A Drug that Evolves
Viruses like SARS-CoV-2, as well as influenza and HIV, evolve over time, becoming resistant to drugs and making it difficult to develop long-lasting treatments. More than two decades ago, Weinberger first proposed the idea of therapeutic interfering particles (TIPs) to treat viruses; rather than directly target a portion of a virus, TIPs compete for resources in an infected cell. By hogging the replication machinery inside a cell, they can keep the virus from churning out more copies of itself.
The benefit of TIPs, though, goes beyond their ability to stifle a virus inside infected cells. Because TIPs reside inside the same cells as the virus they target, they evolve at the same time, staying active even as new viral strains emerge.
"Over the last few years, many of the challenges of the pandemic have been related to the emergence of new variants," says Chaturvedi. "TIPs would be an ideal treatment because they keep learning as the virus evolves, so they could keep the problem of drug resistance in check."
Prior to the COVID-19 pandemic, Weinberger's group was already developing TIPs to treat HIV. In 2020, they quickly pivoted to SARS-CoV-2, developing a single-dose TIP against the virus that can be delivered intranasally.
Last year, they reported that, in rodents, TIPs could successfully block multiple different variants of SARS-CoV-2, reducing the viral load in the lungs by 100-fold and reducing many of the symptoms of COVID-19.
Stopping the Spread
In the new paper, Weinberger and Chaturvedi studied whether TIPs could also reduce viral shedding—a separate question from reducing symptoms and viral load.
The researchers treated hamsters infected with SARS-CoV-2 with the antiviral TIPs and then measured, daily, the amount of virus in the animals' noses. Compared to hamsters that hadn't received the TIPs (called control animals), treated animals had less virus in their nasal passages at every time point. By day 5, all control animals were still shedding high levels of virus, while the virus was undetectable in four out of five TIP-treated animals.
"We know that the amount of virus shed is proportional to how infectious someone is," says Weinberger, who is also the William and Ute Bowes Distinguished Professor and director of the Center for Cell Circuitry at Gladstone. "If viral shedding can be reduced, the number of secondary contacts likely to become infected will also very likely be reduced, which will in turn decrease overall virus dissemination and help keep vulnerable individuals safe."
When the SARS-CoV-2–infected animals were housed in cages with uninfected animals, treatment of the infected animals with TIPs did not fully prevent the transmission of COVID-19. However, it did lead to significantly lower viral loads and milder symptoms of infection in the newly exposed animals.
"This particular laboratory setting is known to generate much more efficient transmission than typically seen in humans, even in household settings, because the hamsters not only transmit via aerosols, but also through bodily fluids and by climbing over and grooming each other for many hours." says Weinberger, who holds the title of professor of biochemistry and biophysics, and pharmaceutical chemistry at UC San Francisco. "So, being able to reduce SARS-CoV-2 transmission in this animal setting is quite promising for being able to reduce human-to-human transmission."
While the initial experiments were done using the Delta strain of SARS-CoV-2, the researchers repeated the tests using the ancestral WA-1 strain of the virus and confirmed that the same TIPs were effective across variants.
Weinberger's team is now seeking FDA approval for a clinical trial to test the TIPs in humans.
More information: Sonali Chaturvedi et al, A single-administration therapeutic interfering particle reduces SARS-CoV-2 viral shedding and pathogenesis in hamsters, Proceedings of the National Academy of Sciences (2022). DOI: 10.1073/pnas.2204624119
The leaders of two congressional committees want a federal probe into whether airlines used government pandemic money to fund pilot buyouts and early retirements that may have fueled current pilot shortages, according to a letter released on Friday.
"As a result of pilot shortages, thousands of flights have been delayed or canceled, wreaking havoc on travel plans for millions of American taxpayers," House of Representatives' Oversight Committee Chairwoman Carolyn Maloney and Coronavirus Crisis Committee Chairman James Clyburn wrote in a Sept. 8 letter to Treasury Department's inspector general.
Spectrum Pharmaceuticals Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved ROLVEDON™ (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.
The Company understands this was a Paragraph III filing. A Paragraph III filing is made when an Abbreviated New Drug Application (ANDA) applicant does not intend to market its generic product until the patent expiration. The FDA will therefore not grant full approval until the expiry of the last of the Company's Orange Book listed patents for the XIFAXAN® (rifaximin) 200 mg product on July 24, 2029.
XIFAXAN 200 mg is indicated for travelers' diarrhea and currently contributes less than 1 percent of Salix revenues.
