Transmissible November 2024, volume 1, issue 1

Introduction

Welcome to Contagion’s first Linkedin newsletter, Transmissible. Each month, our goal is to provide the latest infectious disease news, clinical articles, highlight some of our multimedia projects such as our podcasts, roundtables, and video interviews, as well as our articles from our most recent online edition of our publication, Contagion.

We hope to deliver?quality and relevant information and resources to?health care professionals treating infectious diseases.

Enjoy the issue!

News

FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated Urinary Tract Infections

Iterum Therapeutics plc received approval for Orlynvah as the first oral penem for treating uncomplicated urinary tract infections in adult women with limited treatment options.

The approval was based on data from a pair of phase 3 trials, SURE 1 (NCT03354598) and REASSURE (NCT05584657), demonstrating its effectiveness against infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.

Contagion spoke to Iterum Therapeutics CEO Corey Fishman and Senior VP of Clinical Development Steven Aronin about the approval and what it means to the market.

Watch the full conversation here: FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated Urinary Tract Infections

Japan Approves Updated Self-Amplifying mRNA COVID-19 Vaccine

Japan approved the CSL and Arcturus Therapeutics the updated self-amplifying (SA) mRNA COVID-19 Vaccine, ARCT-154?(Kostaive). The updated vaccine is targeted to protect against the JN1 lineage of omicron subvariants for adults 18 years of age and older.

This became the world’s first such vaccine platform approved when Japan gave it the nod last November. Arcturus Therapeutics is in an exclusive partnership with CSL Seqirus, CSL’s vaccine subsidiary.

Read the full article here: Japan Approves Updated Self-Amplifying mRNA COVID-19 Vaccine

Due to FDA Policy Change, Fecal Microbiota Transplants Are in a Tenuous Position

This fall, there has been some legal limbo going on at the FDA as it pertains to deciding if the federal agency should restrict the nonprofit company, OpenBiome, from continuing to distribute its fecal products for use in fecal microbiota transplants (FMT). This procedure has been a life-saving treatment for both adult and pediatric patients suffering from fulminant Clostridioides difficile for several years.

Prior to this fall, the FDA had allowed the distribution of the company’s fecal products under enforcement discretion for many years. However, the FDA changed its position creating an uneasy, untenable position for the future of FMT—at least in the short term.

Without OpenBiome’s ability to distribute their product, many patients might not have immediate access to FMT, and this is not an ideal situation considering the severity of infection for patients with fulminant C diff, including the possibility it could cause death.

Christian John Lillis Lillis, CEO of the Peggy Lillis Foundation spoke to Contagion about the situation and offered some insights on the importance of having both newer and older modalities for C diff treatment.

Watch the full conversation here: Due to FDA Policy Change, Fecal Microbiota Transplants Are in a Tenuous Position

To read more infectious disease news, go to the Contagion website.

From Our Latest Online Issue

Antimicrobial Resistance: A Catastrophic (and Neglected) Biological Threat

Saskia Popescu, PhD wrote our cover story about antimicrobial resistance (AMR) as a biological threat and areas around preparedness.

To read the article, go here.

What's New In 2024: From the CLSI Subcommittee on Antimicrobial Susceptibility Testing

Morgan Bixby, PhD, Jenna Salay and Betsy Hirsch, PharmD, FCCP, FIDP, FIDSA The provide an update on the breakpoints for a variety of classes of antimicrobials based from the Clinical and Laboratory Standards Institute (CLSI) Subcommittee on Antimicrobial Susceptibility Testing series of meetings earlier this year.

To read the article, go here.

STAY PrEPARED: Understanding COVID-19 Pre-Exposure Prophylaxis

Michael McAlister PharmD, BCIDP and Cara Slaton discuss newer pre-exposure prophylaxis (PrEP) therapeutics and the hope they add to this emerging market.

To read the article, go here.

To read the issue in its entirety, go to our Fall 2024 issue.

Multimedia

A Deep Dive: Understanding the Neurological Toll of Long COVID

This roundtable series discusses Long COVID's prevalence, noting that one in five Americans and one in ten COVID patients may be affected. It features a panel of experts including Ravindra Ganesh, MD, MBBS, FACP, Dip ABOM, Svetlana Blitshteyn, MD, FAAN, and Monica Verduzco-Gutierrez, MD.

Check out the entire series here.

From Pathogen to Infectious Disease Diagnosis

Here is our inaugural podcast with our host, Rodney E. Rohde, PhD, SV/SM/MB(ASCP)CM, FACSc, who interviews guests on connecting lab professionals to clinicians and the intricacies of assays, the next generation of diagnostics, and the nuances of interpreting test results.

Video Collection

We have a library of video interviews with clinicians and key stakeholders in the infectious disease industry.

To see the library go here.

Website Clinical Articles

Echinocandin Dosing Considerations in Obese Patients: A Review

This article comes from our partner, the Society of Infectious Diseases Pharmacists (SIDP) . Taryn Eubank and David Ha, PharmD, review echinocandin dosing considerations in obese patients from the available literature.

Read the entire article here.

INSTIs and Cardiovascular Outcomes: More Complexity

The significance of antiretroviral therapy (ART) has been a game changer for people living with HIV (PLWH). Still, there are some cardiovascular risks associated with different ART classes—particularly protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase strand transfer inhibitors (INSTIs). Peter G. Collin, MD, and Jianxiang Xia, MD review a piece in the literature around this area of study.

Optimizing Vancomycin Therapy: A Review of AUC Calculation Techniques

The ideal parameter for vancomycin monitoring is the area under the curve, which can be calculated using pharmacokinetic equations or Bayesian software. Abdulwhab (Abe) Shremo Msdi , Jacinda C. Abdul-Mutakabbir, PharmD, MPH, and Karen Tan, PharmD, BCIDP write about this topic.

Thanks for reading this month's issue of Transmissible. Please let us know your thoughts on this newsletter. Email assistant managing editor John Parkinson, at [email protected].