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Monday, January 4, 2021

Life sciences SPAC Big Cypress Acquisition raises deal size by 33% ahead of $100M IPO

 Big Cypress Acquisition, a blank check company targeting life science businesses in the US and Israel, raised the proposed deal size for its upcoming IPO on Monday.


The Miami Beach, FL-based company now plans to raise $100 million by offering 10 million units at $10. The company had previously filed to offer 7.5 million units at the same price. Each unit still consists of one share of common stock and one-half of a warrant, exercisable at $11.50. At the revised deal size, Big Cypress Acquisition will raise 33% more in proceeds than previously anticipated.

The company is led by CEO, CFO, and Director Samuel Reich, who previously co-founded Biscayne Neurotherapeutics in 2011 and served as Executive Chairman until its 2018 sale to Supernus Pharmaceuticals (Nasdaq: SUPN) for $185 million. He is joined by Chairman Jeffrey Spragens, who previously co-founded SafeStitch Medical in 2005 and served as CEO until its merger with TransEnterix (NYSE: TRXC) in 2013. Big Cypress Acquisition plans on targeting growth-oriented life science companies that offer novel products and/or platforms with potential to address unmet medical needs.

Big Cypress Acquisition was founded in 2020 and plans to list on the Nasdaq under the symbol BCYPU. Ladenburg Thalmann is the sole bookrunner on the deal.

aTyr: Positive Topline Results in Phase 2 Trial in COVID-19 with Severe Respiratory Complications

 Study met primary safety endpoint in moderate to severe hospitalized COVID-19 patients.

A single dose of 3.0 mg/kg of ATYR1923 resulted in a median time to recovery of 5.5 days.

83% of patients receiving 3.0 mg/kg dose of ATYR1923 achieved recovery in less than a week.

Management hosted conference call and webcast January 4 at 5:00pm ET/2:00pm PT. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event.

https://finance.yahoo.com/news/atyr-pharma-announces-positive-topline-211500350.html


Online appointment system keeps thousands of older people from access to COVID vax

 Thousands of older people may not get the potentially life-saving COVID-19 vaccine as early as hoped because local health departments are forcing those who want an appointment to apply for it online.

This decision is leaving older people who lack access to, or are not comfortable with, technology unable to secure one of the already hard-to-get and coveted spots to get inoculated.

Both Sarasota and Manatee County health departments have created appointment systems in which people have to go online to register for a place in line and then download and print the forms they’ll need.


That’s a nearly impossible task for thousands of older people who either don’t have computers, smartphones or printers or, when they do, are not proficient enough to quickly snap up one of the few available spots.

Nicholas Azzara, a Manatee county spokesman, said Thursday that the county was allotted only 3,500 doses of the vaccine. So officials decided to “distribute the initial batch as efficiently as possible” believing that “a quick, efficient showing early on” would mean the county would get more vaccines, he said.

A spokesman for Sarasota County’s Department of Health did not respond to an email request for a comment on this story. His voicemail was full.

Jeff Johnson, AARP’s Florida state director, said the organization is monitoring the vaccine rollout throughout the state.

He called the pandemic “a catastrophe” in Florida and said his group is working with state officials to make sure seniors know when, how and where to get access to the vaccine.

“AARP Florida believes state and local governments must be transparent about their vaccine distribution plans and keep the American public informed,” he said in an emailed statement.

The local vaccine rollout sheds a light on an issue that’s been made worse by the pandemic as more and more of daily life has shifted online.


While this shift is seen as positive, giving people the ability to work and communicate remotely and mitigating problems like isolation, older people who have been hit hardest by the pandemic have, in large parts, been left behind, experts say.

A November study in the journal Frontiers in Psychology said “this results in a paradoxical situation, in which the population most affected by the lockdown is also the population least helped by the digital tools aiming to mitigate the negative effects.”

Forcing older people, who are the most vulnerable in the pandemic, to go online to access a potentially life-saving vaccine is an example of this. The people who need the vaccine the most are likely the least able to get access to it.

Lisa Merritt, executive director of Sarasota’s Multicultural Health Institute, said the situation is even more difficult for seniors who don’t speak English.

She said that along with the issues other older people deal with, non-English speakers are facing “all kinds of problems and fears” as they try to get answers and look for the vaccine.


“Technology divide, transportation challenges, literacy and English-language issues, distrust of government and mixed messaging,” she said, go along with a “preoccupation with trying to cope with current psychosocial issues and complex chronic health conditions.”

Azzara said plans are in the works to make sure people without access to the internet know what’s going on with vaccines and how to get them when more doses are available.

“Once that plan is fully established,” he said, “we'll work with our aging services division and local partners who serve seniors to disseminate the news and ensure those folks receive vaccinations if they would like to be vaccinated.” 

He expects the process to work similarly to the county’s hurricane emergency system, where emergency management works closely with aging services to make sure people are notified of urgent information.

For those older people who are looking for an appointment but who do not have access to or cannot work on the internet, there are resources available that will help them navigate the system.

Renee DiPilato, director of Sarasota County Libraries and Historical Resources, said seniors who need help can go to any branch to use computers to set up appointments and print forms.

For people who are not comfortable with computers, “staff will be on-site to help those who need it,” she said. 

And in Manatee, Tracie A. Adams, human services program manager for the county’s Neighborhood Services Department, said the elder helpline has seen an uptick in the number of calls it receives since the vaccine became available. 

She said that her staff has attempted to register those who cannot do it on their own and has a list of people to call when more doses become available Monday.

 “I only say attempt to register because we will be going through the process the same as anyone else trying to register for an appointment and we don’t know how quickly they will fill up,” she said.


Azzara, the county spokesman, said that Manatee’s 311 call center can help Spanish and English speakers with the forms and with setting up appointments. The department of health is also available.

“The message we’re stressing is one of patience,” he said.

“We understand the urgency for many thousands of people wanting to be vaccinated. Many people who weren’t able to book an appointment for this first round of vaccinations will be able to find an appointment and vaccine in coming weeks.”

https://www.heraldtribune.com/story/news/local/sarasota/2021/01/04/seniors-withseniors-without-computers-may-lack-access-out-computers-may-lack-access-covid-19-vaccine/4098005001/

Can melatonin reduce the severity of COVID-19 pandemic?

Alex Shneider et al. 

https://doi.org/10.1080/08830185.2020.1756284

PDF: https://www.tandfonline.com/doi/pdf/10.1080/08830185.2020.1756284

Abstract:

The current COVID-19 pandemic is one of the most devastating events in recent history. The virus causes relatively minor damage to young, healthy populations, imposing life-threatening danger to the elderly and people with diseases of chronic inflammation. Therefore, if we could reduce the risk for vulnerable populations, it would make the COVID-19 pandemic more similar to other typical outbreaks. Children don’t suffer from COVID-19 as much as their grandparents and have a much higher melatonin level. Bats are nocturnal animals possessing high levels of melatonin, which may contribute to their high anti-viral resistance. Viruses induce an explosion of inflammatory cytokines and reactive oxygen species, and melatonin is the best natural antioxidant that is lost with age. The programmed cell death coronaviruses cause, which can result in significant lung damage, is also inhibited by melatonin. Coronavirus causes inflammation in the lungs which requires inflammasome activity. Melatonin blocks these inflammasomes. General immunity is impaired by anxiety and sleep deprivation. Melatonin improves sleep habits, reduces anxiety and stimulates immunity. Fibrosis may be the most dangerous complication after COVID-19. Melatonin is known to prevent fibrosis. Mechanical ventilation may be necessary but yet imposes risks due to oxidative stress, which can be reduced by melatonin. Thus, by using the safe over-the-counter drug melatonin, we may be immediately able to prevent the development of severe disease symptoms in coronavirus patients, reduce the severity of their symptoms, and/or reduce the immuno-pathology of coronavirus infection on patients’ health after the active phase of the infection is over.

https://www.tandfonline.com/doi/full/10.1080/08830185.2020.1756284

Variants and Vaccines

 BDerek Lowe

Well, here I am with the first “In the Pipeline” post of 2021, and damn itall, I’m right back to the stuff I was writing about last time. I still expect this year to be the time when we beat back the coronavirus pandemic, and (as a minor side effect for me) to be the year when I can spend more time blogging about other things than viruses and vaccines. But that time is not yet.

No, definitely not. There are a lot of things happening right on top of each other at the moment, and it’s impossible to say yet how they’re going to balance out. On the plus side, we have two vaccines approved in the US, and other countries are starting to use the Oxford/AstraZeneca vaccine or one of the Chinese vaccines. And we have more promising candidates that will be reporting very soon (J&J and Novavax). The minus side is that we’re going to need those very much, because manufacturing and distribution constraints are very real problems. We can argue (a lot) about those, their extents, who’s at fault or not, and all the rest, but I think that we can stipulate with no problem that they are indeed constraints. We have to get a large number of people vaccinated in a short period of time, the largest in the shortest, and as it stands right now neither of those numbers are anywhere near what we need.

I have every expectation that the pace of vaccination will pick up. But the other factor at work is the new coronavirus variant. Since I wrote that post, it’s become even more clear that yes, B.1.1.7 is indeed more infectious. The data from the UK are no longer consistent with its numbers being due to any sort of statistical accident, and it’s now been reported in numerous countries and several US states. At this point, it seems likely that it may follow the same pattern in those areas – and in the US – that it did in the United Kingdom, spreading more rapidly until it becomes the dominant strain in these populations.

That’s not good. Reports so far don’t show B.1.1.7 leading to more severe infections, but spreading the same disease we have now more quickly is still one of the last things we need. The latest data would seem to point to increased viral load in the upper respiratory tract as a big part of the problem – people are presumably shedding more infectious particles more quickly, which would certainly do it. There are many people talking about the cellular entry part of the infection process and whether B.1.1.7 is better at that, but I’m still reading up on the details. That could well be what leads to the increased viral load, but there are other possibilities, too. We’re going to know more about the details, and soon – a huge amount of work is going on in real time – but the increased R for this variant seems hard to refute.

So it’s the UK that’s in the worst shape with this variant right now, from what we can see, and what are they doing about it? This Helen Branswell piece at Stat will get you up to speed. As many will have heard, there are proposals from the British government to delay the second dose of the existing vaccines in order to get first doses into as many people as possible. It appears that our existing vaccines do indeed protect against B.1.1.7 infection, although more data on that would be welcome, but they sure don’t protect the people that aren’t dosed with them; on that we can all agree.

The delayed-dose idea had been floated before, and I wasn’t exactly an early adopter, but the more contagious version of the virus has made me reconsider. But as I was going on about on Twitter the other day, we have to be clear that this is, in fact, an experiment on the population. It seems likely that delaying these doses will likely work out OK. But we don’t have much evidence either way. I’m in favor of doing it, but I’m not happy about ending up in that position. I don’t trust immunology to always work the way that I think it should work, but it seems that we have little choice.

And by “we”, I mean all of us. As mentioned, B.1.1.7 is showing up around the world, including areas whose medical capacities are already being strained. The U.S. is very much included – look, for example, at the situation in Southern California. If things go badly, we could be seeing a big wave of this variant across many parts of the country in the next weeks, and it could be spreading much faster than our vaccination program can knock things back down. We have to get ready for that possibility, and there are already proposals here to adopt the delayed-second-dose protocol. Just in the last day or so, in fact, there’s been another proposal to use 50µg doses of the Moderna vaccine instead of the 100µg doses authorized in the EUA. Moncef Slaoui pointed out that the data submitted by Moderna show that the two doses produce similar immune responses in the 18-55 age group.

That’s another one that you can say will probably work, but there are things to worry about, both in the Moderna dosage idea and the general delay-the second-dose plan. I’ve been watching some very competent people argue these points both ways: here’s Florian Krammer with the possibility that these ideas could end up generating more resistant variants of the coronavirus. The Stat article linked above has similar worries from Paul Bieniasz at Rockefeller and Isabella Eckerle in Geneva, along with other experts who still think it’s the right way to go. But the worries are not just scaremongering from randos online or anonymous bureaucrats who don’t want to fill out more forms; it’s a real possibility, and its chances have to be weighed against the effects of the greater spread of the existing variant with slower vaccination schedules. Both of these could lead to very bad outcomes. Not dosing more people could exacerbate the problem of regions getting overwhelmed with the more contagious variant, with needless deaths due to the loss of hospital capacity. But if we spread out such vaccinations too much and manage to generate another variant that partially or even completely escapes the existing vaccine response, we will be in even worse shape.

I do not know how to make this decision. I really don’t. We have degrees of harm, probabilities of harm, logistics, timing, public health capabilities, politics and more to consider, and not a lot of time in which to consider them. Anyone who uses the phrase “no-brainer” to describe this call should be dropped from your list of people to take advice from. This is the opposite: it’s a decision that all our brainpower may still not be sufficient to make clear. But we’re going to have to make it anyway.

https://blogs.sciencemag.org/pipeline/archives/2021/01/04/variants-and-vaccines

Corticosteroid nasal spray for recovery of smell sensation in COVID-19


Abdelrahman AhmedAbdelalima  Ayman AbdelaalMohamadyaRasha AbdelhamidElsayedbMona AhmedElawadycAbdelhakim FouadGhallaba


Abstract

Objectives

To evaluate the role of the topical corticosteroid, mometasone furoate, nasal spray in the treatment of post COVID-19 anosmia.

Methods

A prospective, randomized, controlled trial was conducted among patients with post COVID-19 anosmia. One hundred patients were randomly assigned to two groups; group I included 50 patients received mometasone furoate nasal spray in an appropriate dose of 2 puff (100 μg) once daily in each nostril for 3 weeks with olfactory training, group II included 50 patients were advised to keep on olfactory training only. The assessment of smell was done using (Visual Analog Scale from 0 to 10). All patients were initially evaluated after their recovery from COVID-19 and followed up for 3 weeks. The smell scores were recorded weekly and the duration of smell loss was recorded from the onset of anosmia till the full recovery.

Results

In both groups, the smell scores significantly improved by the end of the third week (P < 0.001). By comparing smell scores between both groups after 1 week, 2 weeks, and 3 weeks of treatment, there were no statistically significant differences between both groups. In group I, (62%) of patients completely recovered their sense of smell after 3 weeks of treatment, compared to (52%) of patients in group II (P = 0.31).

Conclusion

The results suggested that using mometasone furoate nasal spray as a topical corticosteroid in the treatment of post COVID-19 anosmia offers no superiority benefits over the olfactory training, regarding smell scores, duration of anosmia, and recovery rates.

COVID-19 ARDS: dysregulated host response differs from cytokine storm, may be modified by dexamethasone

 Aartik Sarma, 

Stephanie A. ChristensonEran MickCatherine DeVoeThomas DeissAngela Oliveira PiscoRajani GhaleAlejandra JaureguiAshley ByrneFarzad MoazedNatasha SpottiswoodePratik SinhaBeth Shoshana ZhaPaula Hayakawa SerpaK. Mark AnselJennifer G. WilsonAleksandra LeligdowiczEmily R. SiegelMarina SirotaJoseph L. DeRisiMichael A. MatthayCOMET ConsortiumCarolyn M. HendricksonKirsten N. KangelarisMatthew KrummelPrescott G. WoodruffDavid J. ErleCarolyn S. CalfeeCharles R. Langelier