SIGA (SIGA) Issues Update on Progress in Trials to Assess Use of TPOXX – StreetInsider.com

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SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox.

In recent weeks, randomized, placebo-controlled clinical trials were initiated in three countries including the United States, United Kingdom and Democratic Republic of Congo (DRC) to further assess the safety and efficacy of TPOXX in participants with monkeypox. These randomized clinical trials are now enrolling patients to collect data on the potential benefits of using TPOXX as an antiviral treatment for active monkeypox disease.

About the clinical trials:

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.

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SIGA (SIGA) Issues Update on Progress in Trials to Assess Use of TPOXX - StreetInsider.com