On the 5th (local time), HANDOK’s affiliate Rezolute announced on the 7th that its hypoglycemia treatment candidate RZ358 (Ersodetug), related to tumor-mediated hyperinsulinemia, received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).
The FDA’s Breakthrough Therapy Designation is a system that accelerates the development and review process for drugs that show significant efficacy compared to existing therapies in the early stages of clinical development for serious or life-threatening diseases.
Rezolute is a U.S. biotech venture developing treatment candidates RZ358 for hyperinsulinemia and RZ402 for oral diabetic macular edema. Of these, RZ358 is currently in phase 3 clinical trials for two indications: congenital hyperinsulinemia and tumor-mediated hyperinsulinemia. HANDOK holds the commercialization rights for RZ358 and RZ402 in South Korea.
Nevan Charles Elam, Rezolute’s CEO and founder, noted, “This Breakthrough Therapy Designation acknowledges the therapeutic potential of Ersodetug by the FDA,” adding, “Ersodetug can provide therapeutic benefits when existing standard treatments are insufficient to effectively manage persistent hypoglycemia or when hypoglycemia poses obstacles to surgery or other tumor treatments.” He stated, “Ersodetug is characterized by its ability to act on various forms of hyperinsulinemia,” and highlighted that “successful treatment effects have been confirmed in treatment cases for tumor-mediated hyperinsulinemia patients over the past two years.”
Rezolute plans to start a registrational study of RZ358 (Ersodetug) targeting tumor-mediated hyperinsulinemia patients by mid-year and aims to release topline data in the second half of 2026. Simultaneously, based on this Breakthrough Therapy Designation, they will discuss submitting a Biologics License Application (BLA) for RZ358 for the tumor-mediated hyperinsulinemia indication with the FDA.
Earlier this year, Rezolute also received Breakthrough Therapy Designation for RZ358 for treating hypoglycemia due to congenital hyperinsulinemia. Clinical trials for this indication are currently ongoing in more than 12 countries worldwide.