NIAID reports preliminary data from SIGA’s Mpox treatment study

The study investigated tecovirimat in the treatment of monkeypox virus. Image credit: Corona Borealis Studio/Shutterstock.

The US branch of the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), has published initial results of the PALM 007 clinical trial with tecovirimat from SIGA Technologies for the treatment of monkeypox virus (Mpox).

The placebo-controlled, randomized, double-blind study evaluated the safety and efficacy of oral tecovirimat combined with standard of care (SOC).

Patients from the Democratic Republic of Congo (DRC) were randomly assigned 1:1 to receive either oral tecovirimat plus SOC or placebo plus SOC for 14 days.

NIAID found that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion healing within 28 days of randomization.

However, significant improvement was observed in patients who started treatment within seven days of symptom onset and in patients with severe disease.

In the study, tecovirimat also showed a safety profile comparable to placebo. These results are consistent with various other studies in healthy volunteers.

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive advantage.

Company profile – free sample

Your download email will arrive shortly

We are confident in the unique quality of our company profiles, but we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by filling out the form below.

By GlobalData

Check this box to stop receiving curated industry news, reports and event updates from Clinical Trials Arena.

For more information about our Services, how we use, process and share your personal data, including information about your rights in relation to your personal data and how to unsubscribe from future marketing communications, please see our Privacy Policy. Our Services are aimed at corporate subscribers and you warrant that the email address provided is your corporate email address.

Diem Nguyen, CEO of SIGA Technologies, said: “We are very encouraged by the results of the PALM 007 study, which demonstrated that tecovirimat is safe and offers potential benefit to important patient populations with Mpox disease, particularly those with severe disease and those who sought early treatment. As with other acute viral infections, patients benefit most when antiviral treatment is administered as soon as possible after infection.

“The failure to meet the primary endpoint is not entirely unexpected, given that the population studied was hospitalized and received a high level of supportive care during the treatment period, and that many did not present for treatment until more than a week after the onset of their illness.”