British scientists behind key COVID trial launch study to test monkeypox treatment

SIGA Technologies

23/08/2022 11:30

By Natalie  Grover
    LONDON, Aug 23 (Reuters) - The British scientists behind one
of the major therapeutic COVID-19 trials have turned their focus
to treatments for monkeypox, a viral disease that has been
labeled a global health emergency by the World Health
Organization (WHO).  
    The team from Oxford University behind the so-called
RECOVERY trial - which honed in on four effective COVID
treatments - on Tuesday unveiled a new trial, dubbed PLATINUM,
to confirm whether SIGA Technologies'  SIGA.O  tecovirimat is an
effective treatment for monkeypox.
    Although there are vaccines developed for the closely
related smallpox that can reduce the risk of catching monkeypox,
there are currently no treatments that have been proven to help
hasten recovery in those who develop the disease. 
    More than 40,000 confirmed cases of monkeypox - including a
handful of deaths - in over 80 countries where the virus is not
endemic have been reported since early May. Over 35% of the
current global case count is in the United States, while the UK
has over 3,000 confirmed cases.  urn:newsml:reuters.com:*:nL5N2XF1XF
    The virus is transmitted chiefly through close contact with
an infected person. It typically causes mild symptoms including
fever, rash, swollen lymph nodes and pus-filled skin lesions.
Severe cases can occur, though people tend to recover within two
to four weeks, according to the WHO.
    Siga's drug, branded Tpoxx, has been cleared to treat
diseases caused by the family of orthopoxvirus that includes
smallpox, monkeypox and cowpox by the European Union and United
Kingdom, but due to limited trial data it is generally only used
in severe cases in Britain. 
    In the United States and Canada, the drug is only approved
to treat smallpox. 
    Since smallpox has been eradicated, and cases of monkeypox
and cowpox typically occur sporadically, studies to assess the
effectiveness of the drug in infected people have so far not
been carried out.
    Instead, its effectiveness is based on studies in animals
infected with lethal doses of orthopoxviruses, as well tests of
the medicine's effects in healthy humans.
    The PLATINUM trial, funded by a 3.7 million pound ($4.35
million) UK government grant, aims to recruit at least 500
participants. Participants will either be given a 14-day course
of tecovirimat twice daily, or a placebo. 
    To assess the drug's effectiveness, the rate at which
lesions heal, the time taken until patients test negative for
the virus, and the proportion of patients who require
hospitalisation due to complications will be tracked. 
    "I'm hoping that we can have a result before Christmas, but
it depends on the rate of recruitment," said Sir Peter Horby,
Professor of Emerging Infections and Global Health at the
University of Oxford and the director of the new Pandemic
Sciences Institute.
    Earlier this month, U.S. officials indicated they were
planning a randomized clinical trial in the country to determine
whether tecovirimat should secure U.S. approval for monkeypox.
 urn:newsml:reuters.com:*:nL1N2ZF27W
    Siga, which sells an oral and intravenous formulation of the
drug, has already received $60 million worth of orders for oral
tecovirimat this year.    
    Meanwhile, the only approved monkeypox vaccine - made by
Danish company Bavarian Nordic  BAVA.CO  - is in short supply,
pushing countries to stretch existing supplies.  urn:newsml:reuters.com:*:nL1N2ZV0MZ 
    ($1 = 0.8499 pounds)

 (Reporting by Natalie Grover in London; Editing by Jan Harvey)
 ((natalie.grover@thomsonreuters.com; Twitter: @NatalieGrover;))