Benzinga | Sep 22, 2021 04:06PM EDT

Rezolute Presents Results From Two-Week Natural History Study In Congenital Hyperinsulinism Patients On Standard Of Care Therapies At ESPE 2021

Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today presented results from a natural history study designed to quantify the extent of hypoglycemia in congenital hyperinsulinism (HI) patients on standard of care therapies. The results (E-Poster #P2-234) were presented at the European Society for Paediatric Endocrinology 2021, held virtually September 22-26.

The two-week observational study was conducted in 22 patients ages two years old and older with HI of various genetic causes, 15 of whom were on at least one standard of care therapy, including diazoxide (50% of the patients) and octreotide (18% of the patients). The remaining patients were managed by other means (tube feeds and/or diet). Glucose control was evaluated by continuous glucose monitors (CGM) for at least two weeks.

Study Results

* The mean time in hypoglycemia (?SD, % of monitored time) as measured by CGM (< 70mg/dL) for all participants was 1165 (?164, 11.6%) and 1101 (?152, 10.9%) minutes in weeks 1 and 2, respectively. This included 115 (?36, 0.9%) and 91 (?26, 1.1%) minutes of severe hypoglycemia (<50 mg/dL).

* A 2 to 6 year-old subgroup (n=9) experienced a mean hypoglycemia duration of 1445 (?161,14.3%) and 1376 (?147, 13.7%) minutes in weeks 1 and 2, respectively with 131 (?36, 1.3%) and 146 (?36, 1.5%) minutes of severe hypoglycemia.

* The results equate to an average of over 2.5 hours per day spent in hypoglycemia for all participants, and nearly 3.5 hours per day for those between 2 and 6 years old.

* Notably, patients currently on standard of care therapies experienced a similar magnitude of hypoglycemia.

Current Pediatric Endocrine Society management guidelines recommend maintenance of blood glucose > 70 mg/dL, and consensus guidelines for diabetes hypoglycemia management recommend targeting less than 4% time in the hypoglycemic range (< 70 mg/dL) by CGM. As measured by CGM in this observational study, patients with congenital HI on available standard of care therapies experienced substantial periods of hypoglycemia, leaving them outside of the recommended blood glucose management guidelines.

"Cumulative hypoglycemia places patients with congenital HI at risk for adverse clinical outcomes, including developmental delays and permanent neurologic damage," said Davelyn Hood, M.D., Director, Scientific and Patient Affairs at Rezolute. "This natural history study highlighted the extended periods of hypoglycemia regularly experienced by vulnerable pediatric and adult congenital HI patients on currently available therapies, at levels more than three times the magnitude than is recommended for the management of hypoglycemia in diabetes. These results further validate the urgent need to develop innovative new treatments for congenital HI to more effectively treat hypoglycemia and minimize time outside of the recommended blood glucose range, and also highlight the potential role of continuous glucose monitoring to assess glycemic status and responsiveness to therapies."

Rezolute is currently enrolling patients into the second cohort of the Phase 2b RIZE study of RZ358, the Company's monoclonal antibody for the treatment of HI, with topline data expected in Q1 of 2022.