On Jul. 29, 2021, SIGA Technologies announced that it had entered into a collaboration with Oxford University in the United Kingdom to provide TPOXX (tecovirimat) under an expanded access protocol to treat individuals affected by mpox in the Central African Republic (CAR). Under the agreement, Oxford University sponsor the protocol and study in CAR, and SIGA provided up to 500 courses of TPOXX (tecovirimat) at no cost.

The Institut Pasteur of Bangui (“IPB”), a research foundation established in CAR in 1961, will act as coordinator and be responsible for oversight and conduct of the study in CAR including managing the investigational sites, hosting the clinical trial database and performing the biological testing. The Ministry of Health and Population of CAR (“Ministry”) will be responsible for the administration of TPOXX (tecovirimat) to patients with monkeypox infection at the selected investigational sites.

In addition to providing TPOXX to this study, SIGA is seeking inclusion of treatment of monkeypox in the label indication as it works with the European Medicines Agency (EMA) to obtain regulatory approval for oral tecovirimat (marketed as TPOXX in the United States where that brand name has been approved). The company anticipates EMA approval of tecovirimat in late 2021 or early 2022 and has requested a label indication that includes treatment of smallpox, monkeypox, cowpox, and complications due to vaccinia vaccination.

ISARIC is working with collaboratively with Institut Pasteur Bangui and the Ministry of Health to train health personnel and optimizing delivery and monitoring of tecovirimat treatment. Although not a formal clinical trial, the expanded access program will be conducted following good clinical practices, providing important insights into the effects of tecovirimat when delivered in real-life conditions.”

Mpox is a contagious disease caused by infection with monkeypox virus, a virus closely related to variola virus, which causes smallpox. Mpox is characterized by severe flu-like symptoms and a rash of pus-filled pocks that may cover the whole body. The rash may not occur until approximately two weeks after exposure to the virus, making it difficult to diagnose initially, and, if not fatal, the disease may last nearly a month.. Almost all infections result from exposure to infected animals, although person-to-person transmission is possible. Most cases occur in Central and West African countries, but infections have been documented outside of Africa, including cases in the United States just this month (July 2021) and previously (2003), UK (2018, 2019), and Israel (2018). In comparison to West African strains, infections with Central African strains are typically more severe and more likely to be fatal (1 – 10%). The incidence of disease is likely to continue to increase, both within Africa and elsewhere, as protective immunity in the population decreases. This decreased immunity is due in part to cessation of vaccination for smallpox, which provided cross-reactive immunity to monkeypox, following the eradication of smallpox in 1980.