Aptabio said that the Hungarian health authorities have approved its investigational new drug (IND) application for phase 2 clinical trial of APX-115, a diabetic nephropathy treatment.
Aptabio applied for phase 2 clinical trial of APX-115 in four countries --Hungary, the Czech Republic, Serbia, and Bulgaria – in March. With the approval in Hungary, the company expects to obtain nods from three other countries. Upon completion of all IND approvals, the company will conduct trials on 140 patients in 22 medical institutions.
Aptabio’s candidate is a treatment for diabetic nephropathy based on its NOX inhibitor discovery platform, the company said. NOX consists of the seven enzymes in the body that regulates the production of reactive oxygen species, helping to control oxidative stress levels.
When enzymes are over-produced in the body, the amount of free radicals also increases and causes serious diseases such as fibrosis and inflammation.
According to a recent study, the company's treatment also showed efficacy in treating not only diabetic nephropathy but also the Covid-19 virus. Aptabio confirmed that inhibiting NOX4 in the body has the effect of treating pneumonia and pulmonary fibrosis, and inhibiting NOX2 can stop the infiltration and migration of Covid-19 virus cells.
"APX-115 is one of our major pipelines, and we have been working hard to enter phase 2 clinical trials in Europe quickly," a company official said.