Kind Pharmaceuticals LLC announced that their new drug AND017 for anemia developed by using their profound and unique understanding of the hypoxia mechanism in the human body, has officially entered Phase 1 clinical development. The first-in-human study will be conducted in Australia.
AND017 is an innovative drug for the treatment of anemia. It simulates altitude sickness in the human body in a normal oxygen environment. It is a high-altitude drug, also known as an oxygen-filled pill, and is designed to replace human recombinant erythropoietin (rhEPO) as a first-line treatment for anemia.
The mechanism of action of the drug won the Nobel Prize in Physiology or Medicine in 2019, that is, by specifically inhibiting prolyl-hydroxylase under low oxygen levels. Under this condition, the level of endogenous EPO in the body will be increased to stimulate the production of red blood cells in the bone marrow, achieving the purpose of treating anemia. This is a revolutionary advancement in the treatment of anemia.
In vitro studies of AND017 clearly showed the compound has an active effect on prolyl-hydroxylase-2. In vivo studies showed an evident effect of increased hemoglobin (~4.5g/dL) in a variety of mouse models by AND017, and showed a desirable dose-response effect, as well as excellent pharmacokinetic properties with an acceptable safety profile.
The purpose of the Phase 1 clinical trial of the drug includes safety and pharmacokinetic studies. It is planned to recruit 80 eligible healthy subjects, with up to 10 dose groups, and it aims to evaluate the safety, tolerability and PK of single-dose and multiple doses of AND017 in healthy subjects, providing the basis for formulating dosing regimens for future clinical trials.