On Thursday, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health announced topline results from a preliminary analysis of the PALM 007 trial of tecovirimat, a treatment for the monkeypox virus (MPOX).
SIGA Technologies (NASDAQ:SIGA) markets Tecovirimat, an antiviral drug against orthopoxviruses such as smallpox and MPOX, under the name Tpoxx.
NIAID reported that a comparison of MPOX patients in the Democratic Republic of the Congo who received SIGA’s Tecovirimat versus placebo did not meet its primary endpoint of a statistically significant improvement in the time to clearance of lesions within 28 days after randomization.
Also read: WHO declares Mpox public health emergency: ‘Coordinated international response essential’ to contain epidemic;
All patients included in this study were hospitalized throughout their treatment period.
This study was not a registrational study conducted under an FDA Investigational New Drug application.
Among patients who received tecovirimat, those whose symptoms began within seven days of randomization and those with severe disease saw significant improvements.
“We believe these data warrant further investigation and support our view that post-exposure prophylaxis is essential for the treatment of severe smallpox and all smallpox cases,” said Chief Scientific Officer Dennis Ruby.
Additionally, in this study, tecovirimat demonstrated a safety profile comparable to placebo.
These results are consistent with several previous studies in healthy volunteers and further support the strong safety profile observed with Tecovirimat over the past 15 years.
The PALM 007 study was part of a globally coordinated effort to address the 2022 MPOX outbreak in the Democratic Republic of Congo and around the world.
In PALM 007, patients in the placebo group had much better outcomes than patients in the observational study of the DRC used to design the trial, which may reduce the measured benefit of tecovirimat compared with placebo.
It is not yet known how this controlled environment will affect the trial results.
However, the overall mortality rate among the study participants was 1.7%, whether they received the drug or not, which was much lower than the MPOX mortality rate of more than 3.6% among all cases reported in the Democratic Republic of Congo.
This indicates that mpox patients have better outcomes when hospitalized and receive high-quality supportive care.
Price Action: SIGA shares were down 38.3% during the pre-market trading session to $7.39 as of last check on Thursday.
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This article, “SIGA Technologies’ Antiviral Drug Tecovirimat Doesn’t Improve Lesion Clearance, Stock Tanks in NIH-Supported Congo Monkeypox Virus Study” originally appeared on Benzinga.com.
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