U.S. NIH finds that Tecovirimat, the Mpox drug many countries were stockpiling, is not effective against the new clade I strain!

Mpox News: A Disappointing Revelation
In a startling development, researchers from the U.S. National Institutes of Health (NIH) have discovered that tecovirimat, a drug widely stockpiled by many countries during the recent global mpox outbreak, is ineffective against the more dangerous Clade I strain of the virus currently spreading in Africa. This finding has significant implications for global public health, as Clade I is associated with more severe illness and higher mortality rates compared to the Clade II strain that caused the 2022-23 global outbreak. The research, conducted in collaboration with the Democratic Republic of the Congo's (DRC) Institut National de Recherche Biomédicale (INRB), has raised concerns about the preparedness of health systems worldwide in the face of this evolving threat.


U.S. NIH finds that Tecovirimat, the Mpox drug many countries were stockpiling,
is not effective against the new clade I strain!

Thailand Medical News had also previously covered previous warnings by WHO that even the current Mpox vaccines were not 100% effective against both clades of Mpox as there were many breakthrough infections being reported.

https://www.thailandmedical.news/news/latest-who-warns-of-several-breakthrough-monkeypox-cases-and-now-states-that-current-monkeypox-vaccines-are-not-100-percent-effective
 
With no effective drugs and vaccines, its is worrisome as to how the situation will be handled should the Mpox crisis spiral out of control in terms of spread!
 
The Study: Tecovirimat Fails to Deliver
The NIH-backed study, which enrolled 597 mpox patients from the DRC, aimed to evaluate the efficacy of tecovirimat in treating Clade I mpox. Participants, including both children and adults, were randomly assigned to receive either tecovirimat or a placebo and were monitored for 14 days while receiving high-quality supportive care in a hospital setting. Despite its initial promise, the results were disappointing. Tecovirimat did not reduce the duration of mpox lesions, a critical indicator of its effectiveness. The overall mortality rate among the study participants was 1.7%, a figure lower than the 3.6% mortality rate reported in the DRC at large, suggesting that hospitalization and supportive care were the primary factors contributing to improved patient outcomes.
 
A Closer Look at Clade I Mpox
Clade I mpox, also known as the Central African clade, has been a cause of concern for decades due to its severe clinical manifestations. Unlike Clade II, which typically results in milder symptoms, Clade I is particularly deadly, with a higher prevalence of severe illness and fatalities. The strain disproportionately affects children, with recent data indicating that 67% of suspected mpox cases and 78% of suspected deaths in the DRC occurred in individuals aged 15 years and younger. This alarming trend has prompted the World Health Organiz ation (WHO) to declare a global emergency, underscoring the need for effective treatments and interventions.
 
Implications for Global Health
The findings from this study are a significant setback for global health authorities and pharmaceutical companies that had placed considerable hope in tecovirimat as a viable treatment for mpox.
 
Tecovirimat, also known as TPOXX, was originally developed to treat smallpox, a virus closely related to mpox, and was approved for use in the European Union and the United Kingdom based on animal studies. During the 2022-23 mpox outbreak, countries like the U.S., the U.K., and several European nations stockpiled the drug, anticipating its effectiveness against the virus. However, the recent study's results have cast doubt on its utility against the more virulent Clade I strain, raising questions about the strategic stockpiling of the drug and the preparedness of global health systems to tackle emerging infectious diseases.
 
The Manufacturer's Response: A Call for Further Research
In response to the study, SIGA Technologies, the manufacturer of tecovirimat, acknowledged the disappointing results but emphasized that there was a "meaningful improvement" in outcomes for patients who were treated early and had the most severe cases of mpox. Although these findings were not statistically significant, SIGA has called for further trials to explore the potential benefits of tecovirimat in specific patient subgroups. Despite the negative news, SIGA's share price, which initially plummeted by more than 40%, partially recovered as investors weighed the potential for continued research and development.
 
The Road Ahead: Exploring Alternative Treatments
The NIH and its partners have expressed a commitment to identifying alternative therapeutic options for mpox, particularly in light of the Clade I strain's severity. According to Dr Jeanne Marrazzo, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the study's findings highlight the urgent need for new treatments and vaccines that can effectively combat the evolving mpox threat. Dr Marrazzo told Mpox News journalists that the PALM007 trial, which investigated tecovirimat, is just one component of a broader effort to address the disease in endemic regions like Central Africa. Researchers are now focusing on analyzing the trial data to determine whether certain patient characteristics, such as the duration of symptoms before treatment or the severity of the disease, might influence treatment outcomes.
 
Ongoing and Future Trials: Hope on the Horizon
While the PALM007 trial's results were not what researchers had hoped for, the study provided critical insights into the management of mpox in a hospital setting.
 
The U.S. NIH is continuing to explore the efficacy of tecovirimat in other contexts, including the ongoing international STOMP trial, which is examining the drug's effectiveness against Clade II mpox. Additionally, a similar study called UNITY is underway in Argentina, Brazil, and Switzerland, further evaluating tecovirimat's potential in treating mpox. These trials, along with continued research into other antiviral therapies, are crucial in the global effort to find effective treatments for both Clade I and Clade II mpox.
 
Conclusion: A Call to Action
The recent findings from the NIH and INRB underscore the complexities and challenges of combating emerging infectious diseases like mpox. While the results regarding tecovirimat's efficacy against Clade I mpox are disappointing, they also serve as a clarion call for the global health community to intensify research efforts and develop new therapeutic strategies. The evolving nature of mpox, coupled with the differences between the Clade I and Clade II strains, necessitates a multi-faceted approach to treatment and prevention. As researchers continue to explore new avenues for combating this deadly virus, the lessons learned from the PALM007 trial will undoubtedly play a pivotal role in shaping future responses to mpox and other emerging infectious diseases.
 
This study's findings, although unexpected, highlight the importance of robust clinical trials and international collaboration in the fight against infectious diseases.
 
The PR Release of the study findings can be found here:
https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-mpox-resolution-democratic-republic-congo
 
For the latest Mpox News, Mpox updates as well as other medical news, be sure to check Thailand Medical News.
 
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