Day: October 6, 2021

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Covicept Therapeutics initiates a Phase 2 clinical study with PJS-539, an oral small molecule for the treatment of patients with COVID-19 (SARS-CoV-2)

Covicept Therapeutics initiates a Phase 2 clinical study with PJS-539, an oral small molecule for the treatment of patients with COVID-19 (SARS-CoV-2)

  • Covicept has initiated a Phase 2 multi-center, randomized, double-blind, placebo-controlled 150 patient clinical trial in Brazil
  • The study will evaluate safety and efficacy of PJS-539 in reducing viral load in patients with COVID-19
  • PJS-539 is a potent, once daily, oral pill that inhibits attachment, infection and replication of SARS-CoV-2 and other RNA viruses
  • Covicept is a California-based biotech company funded and operationally supported by Forbion, a leading European life sciences venture capital firm

San Diego, USA, October 6th, 2021 – Covicept Therapeutics, an antiviral drug development company, announced today that a double-blind, placebo-controlled Phase 2 trial of PSJ-539 has been initiated and has begun enrolling patients with mild-to-moderate COVID-19. PSJ-539 has the potential to become a best-in-class small molecule for the treatment of COVID-19 patients and also has potential as a broad-spectrum antiviral drug targeting RNA viruses.

This multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate safety and efficacy of PJS-539 in patients recently diagnosed with COVID-19. The trial in up to 150 patients is being conducted in Brazil, led by Bruno M Tomazini, MD of the Hospital do Coração São Paulo. PSJ-539 is administered once a day over ten days and the primary endpoint of the study will be the effect of two different doses of PSJ-539 on viral load compared to placebo. Secondary endpoints include the frequency of hospitalization and need for mechanical ventilation. Results are anticipated by the end of the year (1). The unique mechanism of action of PSJ-539 may prevent or minimize the development of resistance to vaccines and anti-viral medications.

Covicept has discovered several new host-dependent mechanisms by which PSJ-539 inhibits viral infections underscoring its potential as a broad-spectrum antiviral drug targeting RNA viruses (2). In addition, PSJ-539 has strong anti-inflammatory and anti-fibrotic effects in preclinical models of SARS-CoV-2-induced pneumonia. PSJ-539 has previously been tested in human clinical trials, however its anti-viral potential is novel and Covicept holds an exclusive world-wide license to the new patents.

Large scale GMP manufacturing of PSJ-539 has been established.

Professor Tsimikas, Co-Founder, Chairman and Chief Executive Officer of Covicept, commented: “It is a significant milestone for this program to move into clinical development in less than a year since Covicept was founded. Our team, together with Forbion’s operational and financial support, provides the necessary synergy to bring this medicine to patients infected with SARS-CoV-2 as quickly as possible.”

Sander van Deventer, Covicept Board member and Operating Partner at Forbion, added: “Covicept is a great example of how academic researchers, entrepreneurs, and investors can join forces and in a very agile way bring new therapeutic options to patients. PSJ-539 has potential as a prophylactic and to treat early, moderate and severe disease to reduce viral load, to minimize transmission and infection, as well as to reduce the long-term effects. We are very excited by the progress the team has made in the past nine months and continue to support the company on its way to develop potential blockbuster anti-viral drugs.”

RNA viruses such as SARS-CoV-1 (“COVID”), SARS-CoV-2 (“SARS”), MERS-CoV (“MERS”), Dengue, Chikungunya, Zika and Ebola, are considered to be the most likely causes of devastating global pandemics. Vaccination strategies can prevent the spread of these viruses and protect individuals, but they require a significant lead time before implementation and demonstration of efficacy. Hence, a small molecule that can be stockpiled and used to inhibit viral replication would be an integral component of the response to pandemics caused by RNA viruses.

Details of the Covicept PSJ-539 program and results to date will be presented later today by Dr van Deventer at the Sachs 8th Annual Healthtech Investment Forum in Basel, Switzerland in the Spotlight Showcase at 12.20pm local time.

References

  1. Clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05008393?term=covicept&draw=2&rank=1
  2. Cell paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489987/

About Covicept Therapeutics, Inc.

Covicept Therapeutics, Inc. was founded in 2020 in San Diego, California USA, based on discoveries by Professor Sam Tsimikas, Professor Philip Gordts and Professor Jeffrey Eskowith. It is focused on the development of drugs to treat diseases caused by a variety of RNA viruses, including SARS-CoV-2. It is backed by $2.3 million in seed funding and operational support from leading European VC firm Forbion.

Covicept is developing PSJ-539, a small molecule that inhibits attachment, infection and replication of SARS-CoV-2 and other RNA viruses. PSJ-539 has shown good tolerability and high potency with excellent and high biodistribution to tissues, including the lungs, in humans allowing for relatively low daily doses. PSJ-539 also inhibits fibrosis, a property that may be valuable for patients infected with SARS-CoV-2, both short term and long-term. The unique mechanism of action of PSJ-539 may prevent or minimize the development of resistance to vaccines and anti-viral medications.

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the
(bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. For more information, please visit: www.forbion.com

Contacts

Covicept Therapeutics, Inc.
Professor Tsimikas, Co-Founder, Chairman and Chief Executive Officer
Tel: +1 (0) 858 699 3528
Sander van Deventer, Covicept Board director and Forbion Operating Partner
Tel: +31 (0) 6 5498 2592

Forbion
Laura Asbjornsen, Head of Communications
Email: laura.asbjornsen@forbion.com
Tel: +31 (0) 35 699 30 00

Consilium Strategic Communications
Ashley Tapp, Sue Charles, Kris Lam
Email: Covicept@consilium-comms.com
Tel: +44 (0)20 3709 5700

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Ceridian to Deliver Dayforce Payroll Across Nine New Markets

TORONTO and MINNEAPOLIS, Oct. 05, 2021 (GLOBE NEWSWIRE) — Ceridian (NYSE: CDAY; TSX: CDAY), a global leader in human capital management (HCM) technology, today announced plans to deliver Dayforce Payroll across nine new markets, including Germany, Hong Kong, Indonesia, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand.

Today, organizations around the world use Dayforce Payroll to reduce global compliance complexities and enable real-time auditing of payroll data to pay their people accurately and on time. Dayforce Payroll bridges the gap between pay and time, removing the pressure and burden of the traditional payroll process.

“The Dayforce platform’s continuous calculation of pay and time within a single solution has redefined how global enterprises experience payroll,” said Joe Korngiebel, Chief Product and Technology Officer, Ceridian. “We’re excited to bring Dayforce Payroll to nine new markets to drive increased business value for our customers, while delivering superior user experiences for their people.”

With ever-changing compliance and regulatory requirements, multinational organizations can achieve a competitive advantage by adopting a modern payroll solution that helps minimize risk and protect the bottom line. Ceridian seamlessly facilitates global pay in over 160 countries allowing employers to navigate their international workforces through one consolidated system, including country-specific details down to the employee level.

“We look forward to helping our customers with operations in APJ and EMEA to better navigate the complexities of today’s business world by providing accurate, compliant, and always-on payroll solutions as part of our global HCM leadership,” concluded Korngiebel.

We anticipate that Dayforce Payroll will be available in these new markets beginning in 2022. To learn more about Dayforce Payroll, visit: Ceridian.com/Payroll

About Ceridian
Ceridian. Makes Work Life Better™.
Ceridian is a global human capital management software company. Dayforce, our flagship cloud HCM platform, provides human resources, payroll, benefits, workforce management, and talent management functionality. Our platform is used to optimize management of the entire employee lifecycle, including attracting, engaging, paying, deploying, and developing people. Ceridian has solutions for organizations of all sizes. Visit Ceridian.com or follow us @Ceridian.

Forward-Looking Statement

This press release contains forward-looking statements that involve a number of risks and uncertainties. Statements that are not historical facts, and our expectations, hopes, intentions or strategies regarding the future are forward-looking statements. Forward-looking statements are based on management’s beliefs, as well as assumptions made by, and information currently available to, management. Because such statements are based on expectations as to the future and are not statements of fact, actual results may differ materially from those projected. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release should be read in conjunction with the risks detailed in the “Cautionary Note Regarding Forward-Looking Information,” “Forward-Looking Statement”, “Risk Factors” and other sections of Ceridian’s Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and other filings with the Securities and Exchange Commission.

Media Contact:

Fahd Pasha
647.417.2136
Fahd.Pasha@Ceridian.com

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WHO Backs Malaria Vaccinations for African Children

The World Health Organization recommended Wednesday that children in sub-Saharan Africa and other regions on the continent with moderate-to-high malaria transmission receive a malaria vaccine.

The vaccine, known as Mosquirix, proved effective in a pilot program in Ghana, Kenya and Malawi that has reached more than 800,000 children since 2019.

The WHO said malaria is a top killer of children in sub-Saharan Africa, causing the deaths of more than 260,000 children under age 5 every year.

The vaccine, which requires four doses, counters P. falciparum, “the most deadly malaria parasite globally, and the most prevalent in Africa,” WHO said in a press release.

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” Dr. Matshidiso Moeti, WHO regional director for Africa, said in a statement. “We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults.”

Substantial benefit

According to WHO, pilot program data showed that more than two-thirds of children who were not sleeping under bed nets were benefiting from the vaccine, and that there was a 30% reduction in “deadly severe malaria, even when introduced in areas where insecticide-treated nets are widely used and there is good access to diagnosis and treatment.”

The pilot program also found that the vaccine had a “favorable safety profile” and was “cost effective.”

According to The Wall Street Journal, it could still be years until the vaccine is widely available.

The vaccine has been under development for 30 years by GlaxoSmithKline, a global pharmaceutical company; PATH, a global nonprofit focused on health issues; and some African research organizations, WHO said.

The Bill & Melinda Gates foundation provided late-stage development funding for the vaccine, WHO said.

Source: Voice of America

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Laos logs 484 new Covid-19 cases, one new death

Some 484 new Covid-19 cases have been recorded nationwide over the past twenty four hours with the total reaching 26,462 including 6,558 active cases and 23 deaths.

Deputy Director General of the Department of Communicable Disease Control, Ministry of Health, Dr Sisavath Soutthanilaxay told a press conference today that the new confirmed cases included 468 local infections and 16 imported cases.

Some 284 patients were discharged from hospital today.

The local infections were reported in Vientiane 206, Luang Prabang 96, Bokeo 78, Savannakhet 58, Vientiane (province) 17, Champassak seven, Khammuan four and Xieng Khuang two.

The imported cases included seven each in Savannakhet and Vientiane and two in Bokeo.

Source: Lao News Agency

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Amazon’s Twitch Hit by Data Breach

Amazon.com Inc.’s livestreaming e-sports platform Twitch said Wednesday that it had been hit by a data breach. It gave no details.

An anonymous hacker claimed to have leaked Twitch data, including information related to the company’s source code, clients and unreleased games, according to Video Games Chronicle, which first reported the news of the hack.

Twitch confirmed the breach and said its “teams are working with urgency to understand the extent of this.”

The company declined to comment further and said ((https://twitter.com/Twitch/status/1445770441176469512)) it would “update the community as soon as additional information is available.” Amazon did not immediately respond to a request for comment.

The hacker’s motive was to “foster more disruption and competition in the online video streaming space,” according to the Video Games Chronicle report.

About 125GB of data was leaked, including information on Twitch’s highest-paid video game streamers since 2019, such as a $9.6 million payout to the voice actors of popular game “Dungeons & Dragons” and $8.4 million to Canadian streamer xQcOW, the report said.

“Twitch leak is real. Includes significant amount of personal data,” cyber security expert Kevin Beaumont tweeted.

Twitch, which has more than 30 million daily visitors on average, has become increasingly popular with musicians and video gamers. They interact with users while live streaming content.

The platform, which was boycotted earlier this year by users for not doing enough to block harassment, previously made a move to ban users for offenses such as hate-group membership and credible threats of mass violence.

Source: Voice of America

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Americans Being Warned of Deadly Fake Medication

Americans are being warned to beware of potentially deadly fake prescription pills that are laced with the powerful opioid fentanyl and the highly addictive stimulant methamphetamine. The counterfeit tablets are linked to a wave of drug overdoses killing unsuspecting users.

In its first warning in six years, the Drug Enforcement Administration (DEA) said international and domestic criminal networks were mass-producing fake pills and falsely marketing them as legitimate prescription medication.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before,” said DEA Administrator Anne Milgram at a news conference in Washington.

The notification was issued last week after the DEA announced it had seized more than 1.8 million fake pills during a two-month undercover operation and had arrested more than 810 people. In a statement, the agency said it had confiscated more than 9.5 million potentially lethal pills in the last year.

“Illicit fentanyl was responsible for nearly three-quarters of the more than 93,000 fatal drug overdoses in the United States in 2020,” said Deputy Attorney General Lisa Monaco. Health officials report fentanyl was responsible for nearly 70,000 of the overdose deaths.

Powerful pills

U.S. law enforcement investigators say the majority of counterfeit medication found in America is being made in labs in Mexico using chemicals imported from China. The DEA believes Chinese traffickers have switched from primarily manufacturing finished fentanyl to exporting precursors of the synthetic opioid to Mexican cartels, which then manufacture illicit fentanyl. U.S. officials are now seeking greater cooperation from Mexican law enforcement agencies to disrupt trafficking in the country.

DEA laboratory testing revealed that two out of five fentanyl-laced fake pills seized contained a potentially deadly dose of just 2 milligrams. Fentanyl can be 100 times more powerful than morphine. Drug researchers say a deadly dose of fentanyl is small enough to fit on the tip of a pencil.

“The fake pills seized were capable of killing more than 700,000 people,” Milgram noted, adding that law enforcement agencies have sought to shut down criminal distribution networks selling tablets that look exactly like name-brand prescription medications. “We are alerting the public to this danger so that people have the information they need to protect themselves and their children.”

The DEA alert said medications prescribed by doctors and dispensed by licensed pharmacists were safe, but pills acquired by other avenues were potentially deadly.

Decades of death

Since 1999, more than 500,000 Americans have died of opioid overdoses, both prescription and nonprescription. Deaths rose in nearly all states, with the highest increases in California, Kentucky, Vermont, South Carolina and West Virginia, according to the Centers for Disease Control and Prevention.

The more than 9.5 million fake tablets seized this year represented 430% more than the number seized in 2019. The DEA also confiscated ingredients used to make tens of millions of pills, including more than 4,000 kilograms of methamphetamine.

“The pervasiveness of these illicit drugs, and the fatal overdoses that too often result, is a problem that cuts across America from small towns to big cities and everything in between,” said Monaco.

The most common counterfeit pills are being made to look identical to prescription medications such as Oxycontin, Xanax, Vicodin or stimulants like amphetamines. Investigators say the fake medications are widely available and sold on social media platforms as well as on the streets.

“The illicit drug supply introduces even greater uncertainty about what people are taking, and that contributes to overdoses.” Dr. Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, told VOA. “If someone combines fentanyl with heroin or methamphetamine or another illicit product, it can be deadly.”

Source: Voice of America