PALM 007 Study Results for Tecovirimat in Mpox Treatment Released

The National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) recently unveiled preliminary findings from the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial. The analysis, which focused on patients in the Democratic Republic of the Congo (DRC) with monkeypox (mpox), indicated that the study did not achieve its primary goal of demonstrating a significant statistical improvement in the time to lesion resolution within 28 days post-randomization for those treated with SIGA’s tecovirimat compared to a placebo. Participants in this trial were hospitalized throughout the treatment period.

However, some positive outcomes were noted in specific patient groups. Patients who began treatment within seven days of symptom onset and those with severe disease—defined by the World Health Organization (WHO) as having 100 or more skin lesions—showed meaningful improvement when treated with tecovirimat. These results hint at the potential benefits of administering tecovirimat early in the infection and to those with severe manifestations of the disease. Further trials are suggested to explore these potential benefits more comprehensively.

The study also reaffirmed tecovirimat's strong safety profile, as it exhibited safety comparable to the placebo. This finding is in line with previous research conducted over the past 15 years which has consistently shown the safety of tecovirimat.

Diem Nguyen, Chief Executive Officer of SIGA, expressed optimism about the findings, highlighting the potential benefits of tecovirimat for patients with severe mpox and those who seek early treatment. Nguyen noted that while the study did not meet its primary endpoint, this was not entirely unexpected given that all patients were hospitalized and received a high level of supportive care, with many presenting for treatment more than a week after the onset of illness.

Nguyen also emphasized that SIGA and NIAID are thoroughly analyzing the data to understand the results and their implications. He stressed the importance of further research to evaluate the impact of early treatment on improving outcomes in mpox patients in real-world settings. SIGA is committed to using these findings to develop effective treatment regimens for mpox and other infectious diseases.

The PALM 007 trial is a part of a global effort to address the 2022 mpox outbreak. The study was designed to include patients at different stages of disease progression, ages, and health conditions. To ensure accurate data collection and patient care, all participants were hospitalized for the duration of the treatment. This controlled environment might have influenced the trial results, as patients in the placebo group had more favorable outcomes compared to those in observational studies from the DRC.

Ongoing research around the world is expected to provide further insights into the potential benefits of tecovirimat for mpox patients. Four additional randomized clinical trials—STOMP (U.S. and other countries), UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU)—are currently enrolling patients. These trials will help determine whether the results from PALM 007 were affected by factors such as trial design, patient population, medical protocols, or disease variations.

Nguyen acknowledged the support of various partners, including the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and Institut National de la Recherche Biomédicale (INRB), as well as the patients and investigators involved in the trial. Their dedication has been crucial in advancing the understanding of tecovirimat as a treatment for mpox.

In summary, while the PALM 007 trial did not meet its primary endpoint, it provided valuable insights into the safety and potential benefits of tecovirimat for certain groups of mpox patients, particularly those treated early and those with severe disease. Further research is needed to explore these findings and develop effective treatment strategies.