Tag Archives: Drug Resistant Bacterial Infections

Antimicrobials Working Group (AWG) Announced the Addition of ACURX Pharmaceuticals To Its Coalition Of Companies With the Mission To Combat Drug Resistant Infections

The Antimicrobials Working Group (AWG) announced August 5, 2021 the addition of Acurx Pharmaceuticals, Inc. to its coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations. This new addition brings AWG’s membership to 13 antimicrobial drug companies.

Acurx is a clinical stage biopharmaceutical company developing a new class of antibiotics for infections caused by bacteria listed as priority pathogens by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). Their lead product candidate, ibezapolstat, is a first-in-class of a new class of DNA pol IIIC inhibitors which is in Phase 2 clinical development to treat C. difficile Infection (CDI). Ibezapolstat is the first antibiotic candidate intended to work by blocking the DNA Pol IIIC enzyme, the enzyme necessary for replication of the DNA of the C. difficile bacterial cell.

“We are delighted to have Acurx join AWG and add their voice to our mission to improve the antimicrobial drug and device environment to provide doctors and patients with innovative treatment options for difficult to treat infectious diseases,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics and Chairman of AWG. “Through the collective power of our membership, AWG will continue to engage with key legislators and stakeholders to drive public policy that will stabilize the fragile antimicrobial ecosystem, enable appropriate patient access to novel products, and spur much-needed research and development to help combat the growing threat of antimicrobial resistance. We look forward to working with Acurx to accomplish these goals.”

Bob DeLuccia, Executive Chairman of Acurx, stated: “Antibiotic-resistant Gram-positive infections are substantial societal, public health, and economic burdens worldwide. Methicillin-Resistant Staphylococcus aureus (MRSA) alone accounts for more than half of the infections in US-hospitalized patients, more than any other category of pathogens, including the most problematic serious Gram-negative infections combined. He further stated: “Acurx is pleased to join the AWG and support its efforts to improve the regulatory, investment and commercial environment for successful antimicrobial drug development and commercialization, thereby ensuring preparedness for the next pandemic, antimicrobial resistance, for the benefit of patients worldwide.”

All pharmaceutical and biotechnology companies developing new antimicrobial therapeutics and diagnostic devices are eligible for consideration of membership in AWG. If you are interested in learning more about becoming a member of AWG, please contact us here.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company’s approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (PRSP).

For more information, please visit: www.acurxpharma.com.

About The Antimicrobials Working Group

AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of thirteen antimicrobials companies: Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), Cidara Therapeutics Inc. (NASDAQ: CDTX), , Crestone, Inc., Entasis Therapeutics Inc., Iterum Therapeutics Ltd. (NASDAQ: ITRM), Melinta Therapeutics Inc. (NASDAQ: MLNT), Nabriva Therapeutics US Inc. (NASDAQ: NBRV), Paratek Pharmaceuticals Inc. (NASDAQ: PRTK), Qpex Biopharma, Inc., SCYNEXIS Inc. (NASDAQ: SCYX), Summit Therapeutics plc (NASDAQ: SMMT) (AIM: SUMM), UTILITY therapeutics Ltd., and Venatorx Pharmaceuticals, Inc.

For more information, visit: www.antimicrobialsworkinggroup.org

About The Conafay Group

The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

For more information, visit: www.conafaygroup.com

 

United Nations Releases Critical Warning On Growing Concerns of Drug-Resistant Infections

With more and more common medications losing their ability to fight dangerous infections, and few new drugs in the pipeline, the world is facing an imminent crisis that could lead to millions of deaths, a surge in global poverty and an even wider gap between rich and poor countries, the United Nations warned in a report on April 29th – 2019.

Drug-resistant infections already claim 700,000 lives a year, including 230,000 deaths from drug-resistant tuberculosis, the report said. The rampant overuse of antibiotics and anti-fungal medicines in humans, livestock and agriculture is accelerating a crisis that is poorly understood by the public and largely ignored by world leaders. Without concerted action, a United Nations panel said, resistant infections could kill 10 million people annually by 2050 and trigger an economic slowdown to rival the global financial crisis of 2008.

The problem threatens people around the world. During the next 30 years, the United Nations experts said, 2.4 million people in Europe, North America and Australia could die from drug-resistant infections, making routine hospital procedures like knee-replacement surgery and childbirth far riskier than they are today.

“This is a silent tsunami,” said Dr. Haileyesus Getahun, director of the U.N. Interagency Coordination Group on Antimicrobial Resistance, which spent two years working on the report. “We are not seeing the political momentum we’ve seen in other public health emergencies, but if we don’t act now, antimicrobial resistance will have a disastrous impact within a generation.”

 

To read article in its entirety please click on the following link to be redirected:

https://www.nytimes.com/2019/04/29/health/un-drug-resistance-antibiotics

IDSA and SHEA Release New Antibiotic Stewardship Guidelines

In The News

April 2016

Preauthorization of broad-spectrum antibiotics and prospective review after two or three days of treatment should form the cornerstone of antibiotic stewardship programs to ensure the right drug is prescribed at the right time for the right diagnosis. These are among the numerous recommendations included in new guidelines released by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) and published in the journal Clinical Infectious Diseases.

“Initially, antibiotic stewardship was more focused on cost savings, and physicians responded negatively to that, because they often felt it was best to give patients the newest, most expensive drug,” said Tamar Barlam, MD, lead co-author of the guidelines, director of the antibiotic stewardship program at Boston Medical Center and associate professor of medicine at Boston University Medical School. “While these programs do save hospitals money, their most important benefit is that they improve patient outcomes and reduce the emergence of antibiotic resistance. When we say stewardship, we really mean stewardship, and increasingly, doctors are realizing it’s important and necessary.”

The White House has called for hospitals and healthcare systems to implement antibiotic stewardship programs by 2020 to ensure appropriate use of these vital drugs and reduce resistance, an escalating problem that threatens the ability to effectively treat often life-threatening infections.

The new guidelines replace those originally created to help with the development of programs when antibiotic stewardship was in its infancy, and instead focus on specific strategies that the evidence suggests are most beneficial to ensure the program will be effective and sustainable. They also note it is key that these programs tailor interventions based on local issues, resources and expertise. To ensure that, the guidelines recommend the programs be led by physicians and pharmacists and rely on the expertise of infectious diseases specialists.

“We want hospital administrators to understand the importance of giving antibiotic stewardship their full support to ensure its success,” said Sara Cosgrove, MD, MS, lead co-author of the guidelines, president-elect of SHEA and associate professor of medicine and epidemiology at Johns Hopkins University, and director of the antimicrobial stewardship program and associate hospital epidemiologist at The Johns Hopkins Hospital, Baltimore. “Distributing a few brochures or holding grand rounds won’t do it. It’s vital that antibiotic stewardship be integrated into the hospital’s culture and that infectious disease specialists guide strategies that have been shown to work.”

The guidelines note that more research needs to be done to determine how to ensure antibiotic stewardship is most effective. However, the best evidence to date suggests a number of components, including the following, will help ensure the implementation of an effective antibiotic stewardship program.

  • Preauthorization or prospective audit and feedback – Targeted antibiotics, such as those that treat emerging drug-resistant bacterial infections, should require preauthorization. This means providers need to get approval to use antibiotics before they are prescribed. Prospective audit and feedback can be an alternate strategy or combined with preauthorization. Prospective audit allows antibiotic stewards to engage the prescribing clinician after the antibiotic has been used, typically after two or three days, to optimize antibiotic treatments. Both methods can reduce antibiotic misuse and decrease the development of resistance. Hospitals should choose one or both of these methods as part of their program based on their local resources and expertise.
  • Syndrome-specific interventions – The guidelines recommend focused multifaceted interventions for the treatment of specific syndromes, rather than trying to improve treatment of all infections at once. For example, Dr. Barlam said those leading a hospital’s antibiotic stewardship program might take a close look at management of pneumonia during winter, including making recommendations to shorten the amount of time people are treated and switching to an oral agent more quickly, and then measuring the results of those interventions. In the fall, the program might focus on urinary tract infections and then several months later, switch to skin and soft tissue infections. “This method makes stewardship more manageable and provides a targeted and clear treatment message rather than trying to disseminate 100 different lessons at the same time,” she said.
  • Rapid diagnostic testing – The guidelines note that rapid diagnostic testing of respiratory specimens can help determine if the cause is viral and therefore reduce the inappropriate use of antibiotics. They also note that the rapid testing of blood cultures in addition to conventional culture is helpful, but should be guided by the antibiotic stewardship team for maximum benefit to the patient.

Other recommendations include reducing the use of antibiotics associated with Clostridium difficile infection, implementing antibiotic time-outs and other strategies to encourage prescribers to perform routine reviews of regimens and using computerized clinical decision support if possible.

The guidelines do not recommend relying solely on passive educational materials to implement antibiotic stewardship because any improvement likely will not be sustained. Lectures and brochures should be used to supplement strategies such as antibiotic preauthorization and prospective audit and feedback, the authors note.

AT A GLANCE

  • Preauthorization and prospective review of antibiotics are among the many recommendations to ensure antibiotic stewardship programs are most effective, suggest new guidelines from IDSA/SHEA.
  • Antibiotic stewardship programs should be led by physicians and pharmacists, including ID specialists, who have the expertise and education to ensure the right drug is being prescribed at the right time for the right diagnosis.
  • Antibiotic stewardship programs must be based on the specific problems identified by the healthcare facility and a realistic examination of available resources to ensure interventions are performed with consistency.
  • These programs have been shown to improve patient outcomes, reduce antibiotic resistance and save money.

In addition to Drs. Barlam and Cosgrove, the antibiotic stewardship program guidelines panel includes: Lilian Abbo, Conan MacDougall, Audrey N. Schuetz, Ed Septimus, Arjun Srinivasan, Timothy Dellit, Yngve T. Falck-Ytter, Neil Fishman, Cindy W. Hamilton, Timothy C. Jenkins, Pamela A. Lipsett, Preeti N. Malani, Larissa S. May, Gregory J. Moran, Melinda M. Neuhauser, Jason Newland, Christopher A. Ohl, Matthew Samore, Susan Seo and Kavita K. Trivedi.

IDSA and SHEA individually have published myriad treatment guidelines and together have published several, including the prevention of healthcare-associated infections and antimicrobial prophylaxis in surgery.

As with other IDSA and SHEA guidelines, the antibiotic stewardship guidelines will be available in a smartphone format and a pocket-sized quick-reference edition.

The full guidelines are available free on the

IDSA website at http://www.idsociety.org

 

SHEA website at http://www.shea-online.org.

 

To read this article in its entirety click  on the following link:

http://www.eurekalert.org/pub_releases/2016-04/idso-nas041216.php