Intramuscular Mepron for Malaria Prophylaxis

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Unmet Need
Despite significant research and clinical efforts, malaria continues as a substantial health problem in over 90 countries.  According to the WHO World Malaria Report, in 2016 there were 216 million cases of malaria worldwide with an estimated 429,000 deaths.  Malaria also poses a serious health threat to tens of millions of nonimmune travellers who visit malaria endemic areas every year.  With the current lack of a clinically proven vaccine, preventing malaria is dependent upon chemoprophylaxis.  Chemoprophylaxis requires repeated and extended drug dosing, and lack of adherence to daily or weekly dosing regimens is a well-documented compromise to their efficacy. 
This invention for long-lived chemoprophylaxis against malaria is based on the intramuscular (IM) administration of the existing, orally dosed anti-malarial drug atovaquone (Mepron™).  It offers an excellent prospect of straightforward repurposing of a safe and effective oral formulation, that eliminates the problem of noncompliance with oral dosing regimens.  Over 25 years of clinical use provide substantial evidence for the safety of atovaquone in humans, at drug exposures much greater than those needed for malaria prophylaxis. 
Technology Overview
Atovaquone is a highly lipophilic compound with low aqueous solubility.  Microcrystalline atovaquone (Mepron) offers the prospect of long-acting slow-release activity when dosed as an intramuscular injection.
Using a stringent mouse model of malaria, Johns Hopkins researchers found that a single intramuscular injection of Mepron protects for five weeks; the same dose given orally protects for just one day.  Intramuscular dosing of the orally approved formulation causes no overt toxicity.  Pharmacokinetic correlates of efficacy suggest that comparable protection will be readily achievable in humans.  
Stage of Development
In vivo mouse model data are available.
Patent Information:
Title App Type Country Serial No. Patent No. File Date Issued Date Expire Date Patent Status
Intramuscular Mepron for Malaria Prophylaxis PCT: Patent Cooperation Treaty PCT PCT/US2018/030764   5/3/2018     Pending
For Information, Contact:
Vera Sampels
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