SIGA's Tecovirimat Study For The Treatment Of Mpox Did Not Achieve Primary Endpoint

(RTTNews) - On Thursday, the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) announced the results of the PALM 007 trial, which evaluated the effectiveness of SIGA Technologies' tecovirimat (Tpoxx) in treating monkeypox in the Democratic Republic of the Congo (DRC).

The trial found that tecovirimat did not achieve its primary objective of reducing lesion duration in both children and adults. However, the overall mortality rate among participants was 1.7%, lower than the DRC's reported monkeypox mortality rate of 3.6%.

NIAID Director Jeanne Marrazzo expressed disappointment at the findings but stressed the need for alternative treatments and the commitment to developing effective interventions for monkeypox in Central Africa and globally.

Co-principal investigator Jean-Jacques Muyembe-Tamfum, director-general of INRB and a professor of microbiology at Kinshasa University Medical School, stated, "This study provided urgently needed evidence to inform the monkeypox response in Central Africa." He also praised the exceptional supportive care that study clinicians provided to all participants, reflecting the expertise and skills that Congolese clinicians have developed in managing monkeypox-related diseases.

SIGA Technologies noted that the controlled hospital environment in which the trial took place may have influenced the data from the comparator group. Patients were hospitalized throughout the study to ensure access to food and accurate data collection, receiving a level of care typically unavailable to most monkeypox patients in real-world scenarios.

Compared to other observational studies from the DRC that informed the trial's design, patients in the placebo group of the recent trial exhibited much more favorable outcomes, potentially diminishing the perceived benefit of Tpoxx, according to Fierce Pharma. The international STOMP trial is currently investigating the safety and efficacy of tecovirimat against clade II monkeypox. Additionally, the UNITY study, sponsored by ANRS Emerging Infectious Disease, is assessing tecovirimat using a similar design to STOMP in Argentina, Brazil, and Switzerland. Both studies will continue to enroll participants and work in close collaboration.