Artemisinin and its derivatives, such as artesunate, artemether, and dihydro-atemisinin (DHA), have for many years been the backbone of treatment of uncomplicated P. falciparum malaria. Parenteral forms of these drugs are also used for the treatment of severe malaria and cerebral malaria, conditions where patients are frequently unable to swallow. Currently available artemisinins used to treat malaria have limitations due to their association with neurotoxicity, thermal stability, and potency.
Artemisinins have also been found to have anti-viral properties, in particular against Human Cytomegalovirus (CMV), a double-stranded DNA virus that is normally latent in healthy seropositive individuals, but which frequently reactivates in immuno-compromised individuals such as patients having undergone Solid Organ Transplantation (SOT) or Hematopoietic Cell Transplantation (HCT). In such individuals, the reactivation of CMV can result in CMV disease of the eyes, lungs, gastrointestinal tract and central nervous system. In severe forms of CMV infection, end-organ failure and death may result. In addition, even in the absence of signs and symptoms, reactivation of CMV in HCT recipients has been associated with a two-fold increase in mortality risk. Current treatments for CMV have limitations in terms of toxicity and efficacy.
HCMV also affects newly born babies who are infected by their mothers in utero. This is called Congenital CMV (CCMV). Neonates who develop CMV disease are at heightened risk for suffering from a variety of developmental disorders including hearing loss, vision loss, intellectual disability, lack of coordination, muscular weakness, and seizures. Current treatments for Congenital CMV are limited by toxicity and there is a significant unmet need for treatments that can safely be administered to neonates.
There is also evidence that artemisinins may be a therapeutic alternative in highly aggressive cancers with rapid dissemination, without developing drug resistance. They also exhibit synergism with other anticancer drugs with no increased toxicity toward normal cells.
The company is currently evaluating appropriate next steps to further the clinical development of Artemisone in relevant patient populations.
Based on our current knowledge, it is likely that Artemisone has in vitro and potential clinical activity against other parasites and viruses. Pre-clinical screening of Artemisone against a number of other parasites/viruses is planned with the intent to initiate an additional development program during 2018.