Thursday, January 6, 2022
Ensysce to be at H.C. Wainwright BIOCONNECT Conference
Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with novel technology platforms that may provide new hope for those in severe pain, today announced management’s participation in the H.C. Wainwright BIOCONNECT Conference being held virtually January 10-13, 2022.
An on-demand presentation from the H.C. Wainwright conference will be available through Ensysce’s Investor Relations website at https://ir.ensysce.com/ beginning January 10, 2022, at 7:00am ET.
The Company’s Chief Executive Officer Lynn Kirkpatrick, PhD and Chief Financial Officer Dave Humphrey will be available for one-on-one and small group meetings with investors. To schedule a meeting with Ensysce management, please contact your conference representative or you may also email your request to ENSC@mzgroup.us.
https://finance.yahoo.com/news/ensysce-biosciences-announces-participation-h-210500109.html
Enanta to update on R&D at JP Morgan
Plans to Initiate First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19, in February 2022
Completes Enrollment for RSVP, a Phase 2 Study of EDP-938 in Community-Acquired Respiratory Syncytial Virus (RSV) Infection in an Adult Population; Plans to Report Topline Data in the Second Quarter of 2022
Announces RSV L-Protein Inhibitor, EDP-323, With Plans to Initiate a Phase 1 Study in the Second Half of 2022
Pipeline Update and Business Review
Respiratory Syncytial Virus
EDP-938, an N-protein inhibitor, is being evaluated in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVPEDs and RSVTx.
RSVP, which is designed to study the effect of EDP-938 on community-acquired RSV infection in an adult population, has completed enrollment and the company plans to report topline data in the second quarter of 2022.
For RSVPEDs, a global, multi-center Phase 2 double-blind, placebo-controlled, dose-ranging study of EDP-938 in children aged 28 days to 24 months designed to enroll hospitalized and non-hospitalized infants and children with RSV, and RSVTx, a global, multi-center Phase 2b, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract, Enanta expects enrollment to continue into 2023.
EPD-323, Enanta’s newest clinical candidate for RSV, is a novel oral, direct-acting antiviral selectively targeting the RSV L-protein, a viral RNA-dependent RNA polymerase that contains multiple enzymatic activities required for RSV replication. EDP-323 has shown nanomolar potency against RSV-A and RSV-B in vitro and is not expected to have cross resistance to other classes of inhibitors. EDP-323 has the potential to be used alone or in combination with other RSV mechanisms, such as EDP-938, to broaden the treatment window or addressable patient populations. Additional preclinical data will be shared at the Conference. Enanta expects to initiate a Phase 1 study in the second half of 2022.
COVID-19 (SARS-CoV-2)
Enanta is initiating a Phase 1 study of EDP-235, its oral 3CL (or main) protease inhibitor (3CLpro or Mpro) specifically designed for the treatment of COVID-19, in February 2022. Recently presented data demonstrated that EDP-235 potently blocked the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells where an EC90 of 33 nanomolar was observed, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection. Preclinical studies showed that EDP-235 has good oral bioavailability without ritonavir boosting and favorable distribution into lung cells as well as other key target tissues, with expected once-daily human dosing. Importantly, EDP-235 has potent antiviral activity across a range of currently circulating SARS-CoV-2 variants, as well as other human coronaviruses.
Hepatitis B Virus
In November 2021, Enanta announced positive final data from both Phase 1b studies of EDP-514 in viremic and NUC-suppressed chronic HBV patients. EDP-514 has Fast Track Designation from the FDA and the company is focused on identifying other compounds to develop with EDP-514 in combination regimens as a functional cure for chronic HBV.
Human Metapneumovirus (hMPV)
Enanta is continuing the development of nanomolar inhibitors of human metapneumovirus, a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma. Clinical candidate selection is targeted for the second half of 2022.
Webcast Information
Enanta’s presentation will take place on January 11, 2022 at 3:00 p.m. ET. A live webcast of the presentation will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta’s website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 60 days.
https://finance.yahoo.com/news/enanta-pharmaceuticals-updates-research-development-120000578.html
Stop Gloating Over COVID Deaths Among Anti-Vaxxers
Hi. I'm Art Caplan. I head the Division of Medical Ethics at New York University's Grossman School of Medicine.
Have you ever heard the word schadenfreude? It's German for taking joy or pleasure in the miseries of others. Sadly, we've seen quite a bit of this taking place during the COVID-19 era.
There was a gentleman reported in The New York Times named Nick Bledsoe, from Alabama, who was an auto mechanic there. He had shared his opposition to vaccines and masks many times since last year on his Facebook page, basically saying, "Don't get vaccinated. I don't care if you ever get a vaccine, come on into my shop. I think vaccines are stupid."
He kept referring to and even cursing President Joe Biden for his mandates, saying, "Biden and his ridiculous vaccine requirements," and he frequently posted misinformation about the safety of vaccines on his website as well.
About 6 months after that, probably sometime in March or April of this year, he wound up on a ventilator. Although he said he wanted to be vaccinated at that time, it was too late. He never left the hospital. He died at the age of 41, leaving behind a wife and four kids. Sadly, if you will, he was an opponent of vaccination and ended up suffering for it.
What happened as a result of this death of someone who was such a critic was that pro-vaccine people began to pile on to his website, insulting him, basically calling him out as a hypocrite, a fool, or worse, and basically leveled all kinds of, if you will, schadenfreude — taking joy in his death.
That raises an ethics question: Should a patient get involved in that, what do you say? Is it ever right to say, "Look, you said all these things and they resulted in your death, so you deserved it or you merited it"? I don't think so.
As much as it might be tempting to say, "You basically have caused harm because you've told others not to vaccinate, you didn't vaccinate yourself, you spread misinformation, and now you got yourself sick and you died," I think the goal here is to try to get people who don't want to vaccinate and don't want to mask to do so — to get better behavior.
I have to say, flat out, that making fun of, insulting, sneering at their surviving spouse, their surviving children, doing it in a public way... I don't think it's going to be persuasive in any way to vaccine critics and opponents. Indeed, it's probably likely to just make them mad and further the divide that exists between pro-vaccine and anti-vaccine, between pro-science and anti-science attitudes that we see all over the United States.
I get the temptation. This guy did some harm by running a website where he put out nonsense and false information, and he paid the price. That's sad enough for his wife and kids. Just commenting on the fact that he died, I think, makes all the points that need to be made about the importance of vaccines.
Would it be useful if, later, one of his children said, "I want to talk about the importance of vaccines because I lost my dad"? Yes, but that's something that the family gets to choose. That's something that the family might decide to do in order to try to correct misinformation or hope that a tragedy doesn't happen to another family.
I absolutely do not encourage badmouthing, finger-pointing, or insulting anybody who's lost someone to COVID-19, even if part of the reason that might have happened is that they didn't take the proper precautions or they didn't follow the best medical advice.
At the end of the day, if we're cruel to those we disagree with, I don't think it's going to move the needle in terms of getting them to do better, to support better practices, or to reconsider some of their opposition to the best tools we have to protect them against diseases like COVID-19.
It just doesn't work that way. I don't think hate delivers.
Obesity Prevention in Infants Benefits Second-Born Too
An obesity prevention program targeted at parents of infants benefited not only firstborn infants but their second-born siblings as well, a new study suggests.
According to a statement from the National Institutes of Health, who funded the study, it is the first such infant obesity intervention to show the spillover effect. Findings were published online Dec. 21, 2021, in Obesity.
The program is called Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, and it included guidance on feeding, sleep, interactive play, and regulating emotion.
Parents were given guidance by nurses who came to their homes on how to respond when their child is drowsy, sleeping, fussy, and alert. They also learned how to put infants to bed drowsy, but awake, and avoid feeding infants to get them to sleep; how to respond to infants waking up at night; when to start solid foods; how to limit inactive time; and how to use growth charts.
The control group program focused on safety and matched the guidance categories. For example, early visits included information on prevention of sudden infant death syndrome for sleep, breast milk storage and formula for feeding, and safe bathing.
Jennifer S. Savage, Center for Childhood Obesity Research, Penn State University, University Park, led the study that enrolled 117 infants in a randomized controlled trial. Mother and firstborn children were randomized to the RP or home safety intervention (control) group 10-14 days after delivery. Their second-born siblings were enrolled in an observation-only ancillary study.
Second-born children were delivered 2.5 (standard deviation, 0.9) years after firstborns. Anthropometrics were measured in both siblings at ages 3, 16, 28, and 52 weeks.
Firstborn children at 1 year had a body mass index (BMI) that was 0.44 kg/m2 lower than the control group (95% confidence interval, −0.82 to −0.06), and second-born children whose parents received the RP intervention with their first child had BMI that was 0.36 kg/m2 lower.
“What we saw here is that it worked again," coauthor Ian Paul, MD, MSc, professor of pediatrics and public health sciences at Penn State University, Hershey, said in an interview.
“Once we imprint them with a certain approach to parenting with the first child, they're doing the same thing with the second child, which is wonderful to see," he said.
He noted that this happened with second children without any reinforcements or booster information.
Paul said it's still not clear which of the interventions – whether related to feeding techniques or sleeping or activity – helps most. And for each family the problematic behaviors may be different.
Responsive parenting programs have shown success previously among firstborns, the authors wrote, but 80% of those children grow up with younger siblings, so an intervention that also benefits them is important.
Weighing the Costs of the Intervention
The intervention was extensive. It involved four hour-plus nurse visits a year, often by the same nurse who built a relationship with the family.
But Ms. Savage said that it is possible to replicate INSIGHT on a larger scale in the United States with the dozens of home visitation models.
“Currently, 21 home visitation models meet the U.S. Department of Health & Human Services criteria for evidence of effectiveness, such as Nurse Family Partnership, Family Check-up, and Early Head Start Home Based Option. There is an opportunity to use home visitation models at the national scale to potentially interrupt the cycle of poor multigenerational outcomes such as obesity," she said.
Paul said the initial investment “can save money in the long term," given what's at stake. “We know that 20%-25% of 2- to 5-year-olds are already overweight or obese and if they are already overweight or obese at that age, that;'s likely to persist."
However, he acknowledged that staff shortages and costs are a challenge.
“Other countries have made that investment in their health care system," he said. “In the U.S. only a fraction of new mothers and babies get home visitation. The kind of work that we did for obesity prevention has not yet been incorporated into evidence-based models of home visitation, though it certainly could be."
Paul said his team is hoping to collaborate with others in the near future on expanding this program to such models of home visitation.
Telehealth, though a less desirable option, compared with in-home visits, could also be utilized, he said.
Short of the comprehensive intervention, he said, many of the concepts can be put into practice by pediatricians and parents.
Paul noted that the Robert Wood Johnson Foundation has endorsed “responsive feeding" as the preferred approach to feeding infants and toddlers. Responsive feeding – helping parents recognize hunger and satiety cues as opposed to other distress cues – is a big part of the intervention.
“Feeding to soothe is not the preferred approach," he said. “Food and milk and formula should be used for hunger." That's something pediatricians may not be stressing to parents, he said.
Pediatricians can also counsel parents on not using food as a reward. “We shouldn't be giving kids M&Ms to teach them how to potty train," he said.
"Promising" Findings
Charles Wood, MD, a childhood obesity specialist at Duke University, Durham, N.C., who was not part of the study, called the findings “very promising."
It also makes sense that the “aha moments" of first-time parents learning from the INSIGHT intervention would carry over to the second sibling, he said.
Wood agreed costs are a big factor. However, he said, the potential downstream costs of not preventing obesity are worse. And this study indicates the benefits may keep spreading with future siblings.
Wood said accessing obesity interventions outside the pediatrician visit can also help. Connecting patients with support groups or dietitians or with a counselor from Women, Infants, and Children can help. However, consistent messaging among the providers is key, he noted.
Wood's research group is investigating text messaging platforms so parents can get answer to real-time questions, such as those about feeding behaviors.
He pointed to a limitation the authors mention, which is that the study was done in mostly White, highly educated, higher-income families.
“There's a big problem with racial disparities and obesity," Wood noted. “We definitely need solutions that address disparities as well."
Mothers included in the study had given birth for the first time and their infants were enrolled after birth from a single maternity ward between January 2012 and March 2014. Major eligibility criteria were that the babies were full term (at least 37 weeks' gestation), single births, and delivered to English-speaking mothers at least 20 years of age. Infants who weighed less than 2,500 g at birth were excluded.
The paper's authors and Wood declared no relevant financial relationships.
This research was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases; and the Department of Agriculture.
Reimbursement for At-Home COVID Tests to Start Next Week
Starting next week, Americans struggling to get tested for COVID-19 will be able to get reimbursed for the cost of rapid at-home tests, according to The New York Times.
In upcoming weeks, people should also be able to order free tests online, White House officials said.
"We know this remains frustrating for people getting tested in many parts of the country," Jeff Zients, the White House coronavirus response coordinator, said during a news briefing on Wednesday. "So we are working to do all we can."
Two weeks ago, President Joe Biden said his administration would buy 500 million rapid tests to distribute to the public for free and that insurance companies would begin reimbursing people for the tests they buy on their own. At the time, Biden said the new initiatives would start "in the coming weeks."
So far, the Biden administration hasn't released specifics for people to order the free tests online. With a massive surge in COVID-19 cases due to the Omicron variant, the demand for at-home tests has outpaced supply, and most retail stores have run out of stock.
Zients said Wednesday that test makers will begin delivering rapid test kits to the federal government next week and that Americans will start receiving free tests "in the coming weeks." The Biden administration will set up a "free and easy system, including a website" where people can order them, he said.
In the meantime, new federal testing sites are opening this week in Philadelphia and Washington, DC, Jen Psaki, the White House press secretary, told reporters on Wednesday. Other testing sites will also open soon in Delaware, Maine, Maryland, Nevada, Texas, and Washington, Zients said, and mobile testing sites are now available in New York City and New Jersey.
Last week, the CDC removed a testing requirement from its new isolation guidelines, which shortened the isolation period from 10 days to 5 days. Public health experts criticized the change, saying that a negative test should be required before people end their isolation.
On Tuesday, the CDC amended its guidance, adding that people who want to end isolation after 5 days can choose to take a test if they have access to one. If the test result is positive, they should stay home for another 5 days. But if the test is negative and they no longer have symptoms, they can end isolation and should wear masks in public for another 5 days.
The CDC took out the testing requirement because rapid tests aren't authorized by the FDA to determine whether someone is infectious, Rochelle Walensky, MD, the CDC director, said during the news briefing on Wednesday. Instead, the tests are authorized to detect infection and are meant to be used back-to-back, as in schools, to confirm that people continue to test negative, she said.
But the CDC amended its guidance this week because "it became very clear that people were interested in using the rapid tests," Walensky said, and she wanted to "provide guidance on how they should be used."
SOURCES:
The New York Times: "Reimbursement for rapid at-home tests will start next week, a White House official says."
C-SPAN: "White House COVID-19 Response Team Briefing," Jan. 5, 2022.
CDC: "COVID-19: Quarantine and Isolation, Updated Jan. 4, 2022."
Every US Cruise With Passengers Has COVID Cases
Coronavirus cases have been reported on every cruise ship sailing with passengers in U.S. waters.
All 92 ships have met the threshold for investigation, according to the CDC, which has either started an investigation or has already investigated and is observing each ship.
The number of ships under investigation has increased rapidly in recent days, The Washington Post reported. The CDC's update on Tuesday used data from the cruise lines submitted Monday, showing that every ship reached the threshold of .1% of passengers testing positive.
Last week, the CDC warned all travelers, including vaccinated people, to avoid cruise ships after COVID-19 cases jumped from 162 during the first 2 weeks of December to more than 5,000 cases during the last 2 weeks of December. The CDC moved cruise ship travel to Level 4, the highest level of risk.
"The virus that causes COVID-19 spreads easily between people in close quarters on board ships, and the chance of getting COVID-19 on cruise ships is very high, even if you are fully vaccinated and have received a COVID-19 vaccine booster dose," the CDC said in updated guidance.
Cruise lines are requiring all crew and most ― if not all ― passengers to be fully vaccinated to board, the newspaper reported. Passengers also need proof of a recent negative test.
In addition to the 92 ships with passengers, 18 ships with only crew members are in U.S. waters, the CDC reported Tuesday. Among those, two have met the threshold for investigation, while three have reported cases but not enough to pass the threshold.
"As part of investigating cruise ships that meet the investigation threshold, CDC will obtain additional information from the cruise ship, such as case exposure histories, details about close contacts, traveler vaccination rates, and medical capacities," Caitlin Shockey, a CDC spokeswoman, told the newspaper in an email.
The CDC will "consider multiple factors" and work with the cruise lines before moving ships from the current "yellow" status to the more serious "red" status that requires ships to return to port or delay sailing, Shockey told the Post. To reach the red status, a ship must have ongoing COVID-19 transmission and the potential for cases to overwhelm medical resources on the ship.
Several cruise ships have been turned away from ports since late December due to passengers or crew members testing positive, the newspaper reported. Most continued their trips but skipped the stops where they were turned away.
On Wednesday, Norwegian Cruise Line announced that it would cancel Norwegian Getaway's 9-day Caribbean trip that was scheduled to leave Miami that day, citing "COVID related circumstances."
The cruise line gave the same reason on Tuesday for bringing the Norwegian Pearl back to Miami after it departed for an 11-night Panama Canal trip on Monday. Passengers were told that the trip was ending after many crew members tested positive, the Post reported, though the specifics weren't disclosed. The ship is scheduled to return to Miami on Thursday.
The cruise line also announced on Wednesday that voyages will be canceled for Norwegian Pearl cruises through Jan. 14, Norwegian Sky cruises through Feb. 25, Pride of America cruises through Feb. 26, Norwegian Jade cruises through March 3, Norwegian Star cruises through March 19, Norwegian Sun cruises through April 19, and Norwegian Spirit cruises through April 23. All guests will receive an automatic full refund, the cruise line said.
"We will never compromise on health and safety and we will of course, continue to take all appropriate action to ensure everyone's well-being and to protect public health," the company said in a statement.
Also on Wednesday, Royal Caribbean Cruises canceled its Spectrum of the Seas cruise for Thursday after nine passengers on its Jan. 2 trip were identified as close contacts of a local COVID-19 case in Hong Kong, according to Reuters. They have tested negative so far, but the cruise ship will return to Hong Kong for more testing.
Sources
The Washington Post: "Every U.S. cruise with passengers has coronavirus cases on board."
CDC: "Travel Notices: COVID-19 and Cruise Ship Travel," updated Dec. 30, 2021.
Norwegian Cruise Line: "Media Statements: Jan. 5 and Jan. 4 announcements."
Reuters: "Royal Caribbean, Norwegian Cruise cancel voyages amid Omicron scare."