SUDA Announces Peer-Reviewed Clinical Publication Of ArTMist In Scientific Journal

27th August 2015, ASX Announcement

SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that a third peer-reviewed article describing ArTiMist™ clinical data has been published 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 article, which is titled, ‘Efficacy of a novel sublingual spray formulation of artemether in African children with falciparum malaria’, sets out the results from SUDA’s two clinical efficacy studies of ArTiMist™ including the Phase III trial in children with severe, complicated or uncomplicated malaria, but who were unable to tolerate oral medication.

In both studies, the efficacy of sublingual ArTiMist™ was compared to the standard-of- care intravenous (iv) quinine. There were 31 children in the Phase II study and 151 children in the Phase III trial. Patients were randomised to receive either ArTiMist™ or iv quinine. The primary endpoint was parasitological success, defined as a reduction in parasite count of ≥ 90 % of baseline at 24 hours after the first dose. In the Phase II study, there was 93% parasitological success with ArTiMist™ versus 67% for iv quinine. In the Phase III study, 94% of ArTiMist™-treated patients compared to 39% of patients treated with iv quinine had parasitological success (p < 0.0001). Indicators of parasite clearance were also significantly superior for children treated with ArTiMist™ than those treated with iv quinine.

SUDA’s CEO, Mr Stephen Carter, commented: “We are delighted to have a third manuscript published in the prestigious AAC journal . It confirms the importance of the clinical data and the high level of interest in ArTiMist™ amongst the scientific community in the field of malaria. The results from the two clinical efficacy studies clearly demonstrate that treatment with ArTiMist™ leads to superior parasite clearance and clinical recovery compared to intravenous quinine. We are working with our advisers as well as groups such as the Medicines for Malaria Venture to bring ArTiMist™ to the market at the earliest opportunity. This publication provides further endorsement of the product and supports our strategy for registration and partnering.”

To download the full document, please click on the link below.