Eastland Medical Systems Ltd (EMS) in conjunction with its UK clinical consultants ProtoPharma Limited announces today the very positive results of the recently completed Phase IIa clinical trial of ArTiMist™, a patented sublingual delivery technology designed to administer the drug Artemether. ArTiMist™ was specifically designed to provide a rapid first line treatment of children with severe or complicated P. falciparum malaria, or uncomplicated P. falciparum malaria with gastrointestinal complications.
The majority of deaths from severe malaria in young children are caused by the delayed administration of effective malaria treatments. Moreover, oral treatment is not adequate for patients who are suffering from vomiting and diarrhea and oral absorption (tablets) is slower and often not possible. It is a fact that many deaths occur due to delays in transferring a patient to a hospital setting where trained staff are on hand.
The results show that ArTiMist™ was rapidly absorbed following first administration via the sublingual route. The new route of administration containing the new formula of Artemether was shown to be safe and well tolerated by patients. The three primary efficacy parameters were met and showed success in the reduction of parasite count within 24 hours after receiving the first dose.
The addressable market for ArTiMist™ is large. It is estimated that alone there are over 90 million children under the age of 5 (the most vulnerable patient population) in sub-Sahara Africa at “high risk” of contracting malaria. It is further reported that children are prone to between 1.6-5.4 episodes of malaria each year. Data relating to the more virulent P. falciparum malarial strain indicate 86 million reported cases in Africa annually and 287 million estimated cases in the overall population. Based on these figures and on the distinct advantages of ArTiMist™ over IV quinine, we have internally estimated a potential market size of between 80 -100 million units in Africa for the <5 years old demographic alone. Asia represents also a large potential market even though the socio-economic and healthcare infrastructure are generally in better shape than in sub- Sahara Africa.