The Africa CDC's declaration of the mpox outbreak as a Public Health Emergency of Continental Security, GIGA-2339's upcoming phase 1 trials for HBV, ActivePure Medical's air decontamination system's success in reducing MRSA and HAIs, and more this week from Contagion.
The Africa Centers for Disease Control and Prevention (Africa CDC) has declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS)—the first such declaration since the agency's inception in 2017. Similarly, the World Health Organization has labeled the mpox outbreaks in Congo and other parts of Africa as a global emergency. The virus has been confirmed in pediatric and adult cases across over a dozen countries on the continent, with a new variant spreading. According to the Africa CDC, at least 13 African countries, including previously unaffected nations like Burundi, Kenya, Rwanda, and Uganda, have reported mpox outbreaks. In 2024, these countries have confirmed 2,863 cases and 517 deaths, predominantly in the Democratic Republic of the Congo (DRC). Suspected cases continent-wide have surged past 17,000, up from 7,146 in 2022 and 14,957 in 2023, highlighting significant issues in surveillance, laboratory testing, and contact tracing.
GIGA-2339, developed by GigaGen, a Grifols company, is poised to enter phase 1 clinical trials following recent FDA approval of the company's investigational new drug (IND) application. This treatment represents the first recombinant human polyclonal antibody for HBV and is slated to begin trials in late 2024. Carter Keller highlighted pre-clinical results showing GIGA-2339's exceptional potency compared to current HBV treatments, noting, “It consists of thousands of antibodies all directed towards the Hepatitis B virus. We call these types of therapies recombinant polyclonal antibody therapies, which are very unique. What we find with our diverse antibody therapy is that it’s over 2000 times more potent than currently available therapies, as demonstrated in both in vitro and in vivo experiments.”
ActivePure Medical has revealed study results showing that its Induct Guardian Series air decontamination system can achieve a 96-99% reduction in methicillin-resistant Staphylococcus aureus (MRSA) and a 70% decrease in total healthcare-associated infections (HAIs) across two hospitals. This advanced technology offers continuous air and surface decontamination, providing automated, human-independent protection in healthcare settings. Deborah (Debbi) Birx, MD, chief medical and science advisor at ActivePure, emphasized the significance of targeting MRSA, “MRSA accounts for about 11% of all hospital-acquired infections, MRSA is responsible for nearly 42% of deaths from these infections, making it incredibly important and deadly, especially for hospitalized patients who are already vulnerable due to trauma or surgical procedures.”
This week saw significant international public health developments with the Africa CDC declaring the ongoing mpox outbreak a public health emergency of continental security and the World Health Organization (WHO) recognizing it as a global health emergency. Mitch Wolfe, MD, vice president of Global Engagement and Governance at Ginkgo Bioworks and former Chief Medical Officer at the CDC, welcomed the WHO's announcement, noting that it aids in organizing and unifying efforts among officials, clinicians, and other stakeholders to combat mpox. Wolfe explained that the WHO declaration imposes certain obligations on member states, enhances awareness, facilitates coordination, releases resources, and prompts countries to strengthen their responses. He expressed relief that the declaration came at an early stage in the outbreak. Wolfe added that both clades of mpox are typically transmitted through close, intimate contact, such as skin-to-skin contact and saliva, and noted that recent observations indicate an increase in transmission, including through sexual contact.
In May, Vedanta Biosciences began the Phase 3 RESTORATiVE303 clinical trial to evaluate VE303, a live biotherapeutic aimed at preventing recurrent Clostridioides difficile infection (rCDI). The trial's primary goal is to assess VE303's safety and efficacy in reducing CDI recurrence after an 8-week period following a 14-day treatment with either VE303 or a placebo. The study targets individuals with Stage 1 (rCDI) and Stage 2 (high-risk primary CDI) infections. Jeffrey Silber MD, Vedanta's chief medical officer, discusses the trial's details, what VE303 is, and its role in the trial.