Handok "Rezolute’s Hyperinsulinism Treatment Receives FDA Breakthrough Therapy Status"

Handok's affiliate, Rezolute, announced on the 7th (local time) that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its treatment for hypoglycemia caused by congenital hyperinsulinism (HI), RZ358(ersodetug).

BTD is a program designed to expedite the development and approval of new drug candidates that demonstrate significant improvement over existing therapies for serious or life-threatening conditions.

The BTD was granted based on results from a Phase 2b clinical trial targeting congenital hyperinsulinism patients. The study showed that over 75% of patients experienced improvements in hypoglycemia without clinically significant hyperglycemia.

Rezolute is conducting Phase 3 clinical trials for ersodetug, targeting both congenital hyperinsulinism and tumor-induced hyperinsulinism. The global Phase 3 trial for congenital hyperinsulinism, including in the U.S., is expected to announce topline results in the second half of this year. Additionally, Rezolute initiated Phase 3 trials for tumor-induced hyperinsulinism earlier this year, with key results slated for release in the second half of next year.

Nevan Charles Elam, Rezolute’s CEO and founder, commented, “This Breakthrough Therapy Designation recognizes ersodetug’s potential to deliver therapeutic benefits for hyperinsulinism patients. We aim to complete patient enrollment for the Phase 3 trial on congenital hyperinsulinism and announce topline results later this year, while also progressing with Phase 3 studies on tumor-induced hyperinsulinism.”

Rezolute is a U.S.-based biotech venture focused on developing targeted therapies for rare and metabolic diseases. Its pipeline includes RZ358 for congenital hyperinsulinism and RZ402, an oral treatment for diabetic macular edema. Handok holds the rights to commercialize RZ358 and RZ402 in South Korea and continues to collaborate with Rezolute during the development phase.