This week, a need for better access to diagnostic technologies for Long COVID, Iterium Therapeutics' discussed their FDA-approved Orlynvah for uncomplicated UTIs, the recent rise in human cases of avian influenza, and more.
Currently, there are no specific diagnostic tests for Long COVID, making diagnosis challenging and often reliant on methods used for other chronic conditions. In Episode 4 of our Long COVID roundtable, experts emphasized the need for validated biomarkers and advanced diagnostic tools, such as functional MRIs and tests for hypercoagulability, to better identify and manage this condition. Clinicians highlighted the importance of thorough clinical evaluations and patient histories, as understanding clinical presentations is crucial in the absence of standardized tests. This discussion underscores a gap between research findings on potential biomarkers and their availability in clinical practice, stressing the need for improved access to diagnostic technologies to enhance understanding and treatment of Long COVID.
Part 1 of our interview with CEO Corey Fishman and SVP of Clinical Development Steve Aronin, MD, discusses Iterum Therapeutics receiving FDA approval for Orlynvah (oral sulopenem), the first oral penem for treating uncomplicated urinary tract infections (UTIs) in adult women with limited treatment options. This approval is based on two phase 3 trials, SURE 1 and REASSURE, which demonstrated the drug's effectiveness against infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. In the SURE 1 trial, sulopenem outperformed ciprofloxacin for fluoroquinolone-resistant infections, while the REASSURE trial showed a superior response rate compared to amoxicillin/clavulanate. With approximately 40 million UTI prescriptions annually in the US, and about 1% attributed to resistant pathogens, Orlynvah offers a significant new treatment option. The FDA's Antimicrobial Drugs Advisory Committee emphasized the need for careful post-market monitoring to prevent off-label use. Overall, Orlynvah represents a promising alternative in the fight against antimicrobial resistance in UTIs. Part 2 of our interview dives deeper in the trials, listen here:
This feature story dives into veterinary and public health officials emphasizes the importance of surveillance and prevention strategies in addressing the recent rise in human cases of avian influenza (HPAI) A(H5N1) in the US, particularly among poultry and dairy workers. The CDC has reported 18 human cases this year, with most infections linked to occupational exposure. Despite concerns about potential human transmission, no human-to-human spread has been identified. Experts advocate for the One Health approach, which integrates human, animal, and environmental health, to effectively monitor and respond to this zoonotic threat. Current efforts include testing and monitoring exposed individuals, as well as promoting vaccination and biosecurity measures to mitigate H5N1 risks in both animal and human populations. The CDC also highlights the need for careful monitoring of wastewater for potential virus presence, as contaminated water could pose risks to individuals in close contact with infected animals or raw milk products.
In the second part of their interview, Debika Bhattacharya, MD MSc, and Su H. Wang, MD, MPH, FACP, discuss the challenges of accessing care for hepatitis B patients and the impact of new US and global guidelines aimed at improving this situation. The guidelines emphasize universal screening for hepatitis B in all adults aged 18 and older, increasing vaccinations, and enhancing access to treatment. Bhattacharya highlights that the shift from risk-based to universal screening will help reach marginalized communities with limited healthcare access. Wang expresses optimism that primary care providers can effectively manage hepatitis B care, especially in resource-limited settings where specialists may be hard to find. The conversation underscores the importance of interdisciplinary collaboration in developing these guidelines to enhance care and prevention efforts.
The CANOPY Phase 3 clinical trial for Invivyd's investigational monoclonal antibody, pemivibart (Pemgarda), showed promising results in reducing the risk of symptomatic COVID-19. During the off-drug follow-up period (months 7-12), participants receiving pemivibart experienced a 64% reduction in symptomatic COVID-19 compared to the placebo group, contributing to an overall 12-month relative risk reduction (RRR) of 76%. The first six months of treatment showed an even higher RRR of 84%. No new treatment-emergent adverse events were reported, confirming a consistent safety profile. The trial included both immunocompromised and immunocompetent adults, addressing the need for effective preventive measures across different populations. Despite the presence of new variants, pemivibart provided substantial protection, highlighting its potential as a pre-exposure prophylactic therapy. Invivyd plans to further explore various dosing routes and continue developing monoclonal antibodies for long-lasting protection against COVID-19.
