Kainos Medicine is developing novel non-nucleoside reverse transcriptase inhibitor (NNRTI) as anti HIV drug. This compound is the same NNRTI class with efavirenz(Sustiva) which is a blockbuster HIV drug marketed by BMS. Efavirenz is known to cause birth defects and should not be used in women who might become pregnant.

In vitro antiviral activity and nonclinical pharmacology assessments of KM023 demonstrate comparable protein adjusted activity versus wild-type HIV, improved retention of activity versus K103N mutant and potential for QD dosing to cover circulating wild-type and major resistant virus. KM023 is compatible with three other classes of antiretrovirals (NRTI, PI and II) and exhibited a potential for improvement in safety profile compared to efavirenz.

Kainos conducted a placebo controlled, Single and Multiple Ascending Dose study (SMAD) in healthy volunteers. KM023 human pharmacokinetics demonstrated that QD dosing is possible covering the K103N mutant display improved safety profile relative to efavirenz and has the potential to be combined with other drugs in a single pill.

We are completed transfer of technology to the Chinese pharmaceutical company and currently proceeding with a strategic joint development for additional clinical trials and commercialization of KM023. The project was designated for Fast-track review by the CFDA in 2016. Currently, clinical study Phase III of KM023 is in progress.