Worldwide, an estimated 36.9 million people are living with HIV (UNAIDS, 2017). The number of patients receiving the anti-retroviral therapy was 21.7 million, an increase of 2.3 million over 2016 (UNAIDS). AIDS-related deaths in 2016 was reported to be around 1 million people, with the highest rate of infection (74 percent) concentrated in Africa (UNAIDS, June 2017). There is a need for new, safe and effective treatments that are amenable to formulation as a combination therapy and can retain activity towards resistant strains.

KM-023, Kainos' HIV drug candidate, belongs to the class of anti-HIV agents known as non-nucleoside reverse transcriptase inhibitors (NNRTI). The market leader (standard of care) in this class, Efavirenz (Sustiva, Stocrin), is part of the fixed dose combination Atripla that combines two additional nucleoside reverse transciptase inhibitors (tenofovir and emtricitabine) and is now prescribed for ~80% of treatment naive individuals. World-wide sales of NNRTIs is expected to peak at approximately $1 Billion by 2018.