suda limited’s artimist™ shown to be a “superi

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Suda Limited’s ArTiMist™ shown to be a “superior” malaria treatment for children
Tuesday, April 30, 2013 by Angela Kean

Suda Limited’s ArTiMist™ shown to be a “superior” malaria treatment for children

Suda Limited’s (ASX: SUD) ArTiMist™ has proven to be an effective treatment for children with malaria, as well as superior to the current treatment for severe malaria, in a recent African trial.

Preliminary results of a phase three African malaria trial in children has demonstrated that sub-lingual (under the tongue) ArTiMist™ is superior to quinine.

Results support the proposal that sub-lingual ArTiMist™ is an effective treatment for children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.

The results also strongly support the potential role that ArTiMist™ may be able to play in the early interventional treatment of malaria in these cases.

The trial was carried out in the malaria endemic areas of Rwanda, Burkina Faso and Ghana over a 22 month period from November 2010 to September 2012.

The study’s primary objective was to demonstrate that sub-lingual ArTiMist™ was superior to IV quinine in the reduction of the parasite counts by over 90% within 24 hours in children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.

The results of the trial demonstrated that 95.6% of patients treated with ArTiMist™ had their parasite counts reduced by over 90% in the first 24 hours.

By comparison, only 40.6% of the quinine treated patients had the same reduction.

The secondary efficacy parameters PCT, PRR24, PCT50, PCT90 demonstrated a statistically significant difference overall between the treatments in both efficacy populations (p < 0.005), further demonstrating the superiority of ArTiMist™ over IV quinine in clearing parasites.

There were 10 early treatment failures for quinine treated subjects. One quinine treated subject required rescue therapy.

For ArTiMist™ treated subjects there were no early treatment failures, and no patient required rescue therapy.

Quinine did not appear to be better than ArTiMist™ for any of the secondary endpoints included in this study.

There were no Treatment Related Adverse Events (TEAEs), deaths or neurological sequelae for either treatment.

Suda had around A$1.3 million in cash at the end of the March quarter 2013.