SIGA Provides Update on Progress in Clinical Trials to Assess Use of TPOXX ® (tecovirimat) for Treatment of Monkeypox

• Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The NIAID-funded AIDS Clinical Trials Group (ACTG) is leading the study, which may later expand to international sites. Study investigators aim to enroll more than 500 participants, including children and those who are pregnant or breastfeeding, from clinical research sites. The trial will also include an open label arm that will include children, pregnant/breastfeeding individuals and those who are immunocompromised or have severe monkeypox disease.
• PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research (NIHR). The trial is being led by researchers at Oxford University and aims to recruit at least 500 participants, including children weighing ≥13 kg, across the U.K.
• PALM 007 is a DRC-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale (INRB). Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and those who are pregnant or breastfeeding, at clinical sites in the DRC.

“We are grateful for the outstanding efforts of our collaborators and partners across the globe to quickly launch placebo-controlled studies to evaluate TPOXX,” said Phillip Gomez, CEO of SIGA. “As the global monkeypox outbreak continues to evolve, these studies can provide new levels of data and further confirm findings related to safety and efficacy that can support regulatory review and potential approval of TPOXX for the treatment of monkeypox in the United States and other countries.”

On July 13, 2018, the US Food and Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In December 2021, oral TPOXX was approved for the same indication by Health Canada. Tecovirimat (TPOXX) was approved by the European Medicines Agency (EMA) in January 2022 and the Medicines and Healthcare products Regulatory Agency (MHRA) in June 2022 with a broader label that covers the treatment of smallpox, monkeypox, cowpox, and complications from vaccination for smallpox.

In addition to providing support for clinical trials, SIGA continues to respond to TPOXX procurement order requests from countries around the world. In a separate press release in September, SIGA disclosed that the Company had received, as of mid September, approximately $76 million of international orders for oral TPOXX from twelve international customers.

SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the U.S. maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. This project has been funded in whole or in part with federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number HHSO100201800019C. For more information about SIGA, please visit www.siga.com.

Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent.