The US National Institutes of Health (NIH) unit, the National Institute of Allergy and Infectious Diseases (NIAID), has released initial results from the PALM 007 clinical trial of SIGA Technologies’ tecovirimat in treating monkeypox virus (Mpox).
The placebo-controlled, randomised, double-blind trial assessed the safety and efficacy of oral tecovirimat along with standard of care (SOC).
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Patients from the Democratic Republic of the Congo (DRC) were randomly assigned in a 1:1 ratio to receive either oral tecovirimat plus SOC or a placebo plus SOC for 14 days.
NIAID noted that the study did not meet its primary endpoint of a statistically significant improvement in time-to-lesion resolution within 28 days post-randomisation.
However, a meaningful improvement was observed in patients who began treatment within seven days of symptom onset and those with severe disease.
In the trial, tecovirimat also exhibited a safety profile comparable with placebo. These findings were in line with various other studies on healthy subjects.
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By GlobalDataSIGA Technologies CEO Diem Nguyen said: “We are highly encouraged by the PALM 007 study results, which showed that tecovirimat is safe and offers potential benefit to important groups of patients with Mpox disease, particularly those with severe disease and those who sought treatment early. As with other acute viral infections, patients benefit the most when antiviral treatment is administered as soon as possible after infection.
“Missing the primary endpoint is not entirely unexpected given that the study population was hospitalised during the duration of treatment receiving a high level of supportive care, and since many presented for treatment more than a week after their illness started.”
