Rezolute, Inc., a U.S. bio-venture in which Handok and Genexine are the largest shareholders, received Rare Pediatric Disease Designation (RPD) from the U.S. Food and Drug Administration (FDA) for RZ358, a treatment for congenital hyperinsulinism that is currently under development, on June 10, 2020.

Handok and Genexine jointly invested in this bio-venture spearheading development of innovative cures for rare illnesses in 2019 to become its largest shareholders. RZ358 is a monoclonal antibody to treat congenital hyperinsulinism, a genetically transmitted endocrine disorder. It is currently undergoing global Phase IIb study, and the first patient was registered in February earlier this year. The FDA’s designation of RZ358 as a treatment for a rare pediatric disease is expected to accelerate its development.

Congenital hyperinsulinism is an extremely rare disease with an incidence rate of one in 25,000 – 50,000 live births. This excessive production of insulin causes repeated hypoglycemia, which can lead to developmental delays, recurrent seizures, comas, and even death.

“With no available treatment indication for congenital hyperinsulinism, patients had no choice but to rely on other treatments and experienced many difficulties, such as severe side effects or limited effectiveness of medicine,” said Rezolute CEO Nevan Elam. “Our drug RZ358 currently under development is a treatment for patients with congenital hyperinsulinism of all ages, including children, and can restore and normalize insulin levels.” He added, “If RZ358 is approved as a new drug, Rezolute will be eligible for a Priority Review Voucher (PRV), which can be applied to subsequent marketing applications. This will contribute significantly to maximizing profits for our shareholders.”