Connect with us

International

Global study to test malaria drug to protect health workers from COVID-19

Global study to test malaria drug to protect health workers from COVID-19

Published

on

COVID-19 Therapeutics Accelerator to fund international trial of chloroquine

IMAGE

Credit: Erin Jones/Barnes-Jewish Hospital

With $9 million in philanthropic support, an international group of physicians and scientists is establishing a research network to evaluate promising therapies for COVID-19. The group, called the COVID-19 Research Outcomes Worldwide Network (CROWN) Collaborative, is testing whether the antimalaria drug chloroquine can prevent COVID-19 infection or decrease its severity in front-line health-care workers. An estimated 30,000 such workers from across the globe will participate in the clinical trial, which the collaborative is calling the CROWN CORONATION trial.

The collaborative and the trial are funded by the COVID-19 Therapeutics Accelerator, an initiative with contributions from an array of public and philanthropic donors, intended to support research and development to bring effective, accessible COVID-19 treatments to market as quickly as possible.

Washington University School of Medicine in St. Louis is the clinical coordinating center for this ambitious international trial. The investigators comprising the CROWN Collaborative are from prominent research organizations in African, European, North American and South American countries, including Cameroon, Canada, Ireland, Ghana, Peru, South Africa, Switzerland, the United Kingdom, the United States, and Zambia.

“Because of their repeated close contacts with infected patients, front-line health-care workers in all parts of the world have a higher risk of contracting COVID-19 than most members of the general public,” said one of the study’s principal investigators, Michael S. Avidan, MD, the Dr. Seymour and Rose T. Brown Professor and head of the Department of Anesthesiology at Washington University. “In some places, more than 10% of those who have become infected are health-care workers. There is an urgent need to identify drugs that are effective at preventing infection or mitigating its severity.”

The study will recruit front-line health-care workers globally, including those from lower- and middle-income countries. That’s important because in many such countries there are relatively few health-care workers per capita, and protecting them from severe COVID-19 infection would provide a substantial public health benefit.

“An important way to protect the public at large is to do our best to protect the health-care workers,” Avidan said “It is very important that there is a global effort to protect health-care workers because when it comes to COVID-19, we’re all in this together. Finding ways to keep health-care workers from getting seriously ill is one of the most important ways to protect vulnerable people everywhere.”

This new trial will be important because of its immense size and global reach, as well as its use of three different but well-established chloroquine dose schedules in healthy people. Health-care workers in the trial will be divided randomly into four groups. Three of the groups will receive chloroquine at various doses. The fourth group will receive an inactive placebo. The researchers want to learn whether the drug can prevent health-care workers from developing COVID-19 disease or decrease the severity of illness for those who do become infected.

The researchers also want to determine the lowest dose required to provide a benefit. Health-care workers in the study will receive lower doses of chloroquine than have been given in most other trials that have focused on treating patients already sick with COVID-19. That is important because lower doses of chloroquine should have fewer side effects. Plus, with a limited supply of chloroquine globally, if a lower dose turns out to be just as effective as a higher dose, many more people could benefit from the drug.

“When people have to travel to parts of the world where malaria is a problem, they often take low doses of chloroquine to help prevent infection,” said Avidan, also a professor of psychiatry and of surgery. “We want to learn whether this drug might work in a similar fashion in the case of COVID-19, or at the very least, whether low-dose chloroquine might help prevent the severe and life-threatening complications associated with the illness.”

The study will last five months. Health-care workers who participate will take chloroquine or a placebo for the first three months and will be monitored for another two months. Those previously infected with COVID-19 or those who have underlying medical problems that might make it unsafe to take chloroquine, such as heart ailments, will not be eligible to participate.

Data from the trial sites will be compiled at University College London. Laurence Lovat, MD, PhD, a professor of gastroenterology and biophotonics, is the study leader in the United Kingdom.

“Our hypothesis is that chloroquine may decrease the COVID-19 burden by decreasing entry of the novel coronavirus into host cells and by inhibiting viral replication,” Lovat said. “Furthermore, with its anti-inflammatory properties, chloroquine might dampen the exaggerated and unregulated immune response in the host, which often is responsible for the unpredictable and severe complications of COVID-19.”

The CROWN CORONATION trial’s other principal investigators are Ramani Moonesinghe, MD, a professor of perioperative medicine at University College London, and Helen Rees, MD, executive director of the Wits Reproductive Health and HIV Institute in Johannesburg.

“In the African region, the health-care workforce is under-resourced and overstretched, and the impact of the COVID-19 pandemic will make this situation worse,” Rees said. “If an inexpensive drug such as chloroquine could help protect our health workers, it would provide important insurance for many countries whose health-care systems could collapse if large numbers of health-care workers were to become infected and could not care for others who were sick with COVID-19.”

The investigative team at Washington University includes Avidan, Mary Politi, PhD, a professor of surgery in the Division of Public Health Sciences; Erik Dubberke, MD, and Elvin Geng, MD, both professors of medicine in the Division of Infectious Diseases; and Graham Colditz, MD, DrPh, the Niess-Gain Professor of Surgery and director of the Division of Public Health Sciences; George Kyei, MD, PhD, an assistant professor of medicine in the Division of Infectious Diseases; Victor Davila-Roman, MD, a professor of medicine, of anesthesiology and of radiology and associate director of the Center for Global Health in the Institute for Public Health.

“There is quite a bit of interest in chloroquine for both the prevention and treatment of COVID-19 infection,” Avidan said. “It has shown promise treating patients with COVID-19, but the only way to determine accurately whether this drug actually works is to conduct rigorous, large-scale, randomized trials in multiple locations.”

Politi, a leader in health decision-making, said she is particularly enthusiastic about the design of the study.

“The trial will be focused on health-care workers and their safety so that they can continue to care for patients around the world,” she said. “In addition to helping us study whether chloroquine works, and at what dose, all participants will receive education about COVID-19 and will be screened for evidence of infection. The trial has an adaptive design to learn from early study results. After a certain time period, if at least two of the chloroquine doses are demonstrating a benefit, we could stop assigning people to take placebo.”

COVID-19 Therapeutics Accelerator donors include the Bill & Melinda Gates Foundation, Wellcome, Mastercard, U.K. Department for International Development, Chan Zuckerberg Initiative, Michael & Susan Dell Foundation, Avast, Zhang Yiming, Alwaleed Philanthropies, EQT and Madonna.

Washington University School of Medicine’s 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

###

Media Contact
Jim Dryden
jdryden@wustl.edu

Original Source

https://medicine.wustl.edu/news/global-study-to-test-malaria-drug-to-protect-health-workers-from-covid-19/

Read More

Continue Reading

International

Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

Published

on

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

Read More

Continue Reading

International

Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

Published

on

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


Read More

Continue Reading

International

Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

Published

on

Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

Shutterstock

This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

More Travel:

With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

Read More

Continue Reading

Trending