ArTiMist® : Malaria

ArTiMist® was designed with a child in mind; a child living in a challenging environment where healthcare resources can be very scarce and time is of the essence. ArTiMist® is the world’s first sub-lingual spray for the treatment of p. falciparum severe paediatric malaria. The active pharmaceutical ingredient in ArTiMist® is artemether, which is a widely used anti-malarial and is currently administered by infusion or orally in a tablet form.

ArTiMist® is administered sub-lingually or under the tongue and enters the bloodstream where the parasite lives, attacking at a far greater speed than conventional tablets and reducing the need for continued hospitalisation whilst presenting significant cost savings to governments and relief organisations. ArTiMist® is especially effective in the treatment of children and young infants who are experiencing malaria-related and gastro-intestinal problems and cannot tolerate tablet treatments.

In April 2013, Suda Ltd released results from its ART004 Phase III trial in 150 patients across multiple sites in Africa. The results confirmed that ArTiMist® was convincingly superior to the current gold standard intravenous Quinine treatment. The key results were:

95.6% 0f ArTiMist® treated patients had a greater than 90% reduction in parasite count in the first 24 hours vs. 40.9% of the Quinine treated patients.

There were 10 early treatment failures in the quinine arm including one that required rescue therapy whilst there were none in the ArTiMist® arm.

There were no treatment related adverse events in the ArTiMist® arm.

% of patients with ≥90% decrease in parasite count within 24 hrs.

Parasite clearance time (hours)

Early treatment failures

ArTiMist®

IV Quinine

ArTiMist®

IV Quinine

ArTiMist®

IV Quinine

95.6%

40.6%

30

68

0

10

The Company submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration in 2017 and aims to commercialise the product through a partnership or divestment.

The WHO estimates that 3.3 billion people or about half of the world’s population is at risk of malaria with 453,000 children deaths reported in 2013 as a direct result of malaria [1]. Clinically, malaria is broadly divided in uncomplicated and severe. The progression from one form to another is very fast and if delayed or left untreated it can be fatal especially in children <5-years old. The mortality rate of untreated severe malaria is thought to approach 100% and if treated, it falls to 15-20%.

Most malaria deaths occur in rural areas where healthcare facilities are more often than not several hours away. It is therefore vital to slow-down the disease progression while on-route to a hospital where parenteral artemisinin derivatives or quinine can be administered. ArTiMist® could be used in pre-referral settings, to dose those children that require transfer to a fully equipped medical centre given the severity of their condition. The pre-referral phase of the treatment is currently managed by administering artesunate rectal suppository (ARS), if other options are not available. However, ARS is not indicated if a child is suffering with diarrhoea.

Extensive marketing studies of anti-malarials indicate a potential market size in excess of 300 million doses per year. ArTiMist® addresses a major global unmet medical need in the treatment of children with severe malaria and directly addresses a WHO requirement to provide a novel solution to minimise treatment delays to reduce morbidity.

In 2011 ArTiMist® was identified by Thompson Reuters as one of the World’s 5 most promising drugs in Phase III clinical development. Its intrinsic characteristics (efficacy, user-and-patient friendly, hygienic and non-toxic) could make ArTiMist® the treatment of choice in urban and in rural locations, as its initial administration could be done at community level by individuals that are not necessarily medically trained.

Three peer-reviewed articles describing the ArTiMist® clinical results were published in 2015 in Antimicrobial Agents and Chemotherapy (AAC), which is a journal of the American Society for Microbiology. The AAC is one of the most respected peer-reviewed scientific journals for preclinical and clinical data on novel anti-malarial treatments. The abstracts and articles can be accessed via the following links:

Pharmacokinetics of a novel sublingual spray formulation of the antimalarial drug artemether in healthy adults

Pharmacokinetics of a novel sublingual spray formulation of the antimalarial drug artemether in African children with malaria

Efficacy of a novel sublingual spray formulation of artemether in African children with falciparum malaria

 

If you are interested to learn more about ArTiMist®, please email This email address is being protected from spambots. You need JavaScript enabled to view it. (Chief Business Officer).


[1] WHO World Malaria Report 2014