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▎WuXi AppTec Content Team Editor On March 23, 2022, Rezolute announced that its investigational therapy RZ358 has achieved positive results in a Phase 2b clinical trial
.
Trial data show that RZ358 can significantly improve hypoglycemia in patients with congenital hyperinsulinemia (HI), with good safety and tolerability
.
RZ358 is a humanized monoclonal antibody that binds to a unique stereogenic site on insulin receptors in liver, fat and muscle
.
The antibody counteracts the effects of elevated insulin in the body by regulating insulin binding, signaling and activity, thereby maintaining glucose levels within the normal range
.
Rezolute believes that RZ358 is well suited as a potential therapy for congenital hyperinsulinemia (HI), and other diseases characterized by excessive insulin levels
.
And, because RZ358 acts downstream of pancreatic islet β cells, it is expected to be broadly effective in the treatment of congenital HI caused by any underlying genetic defect
.
In addition, the US FDA has granted RZ358 Orphan Drug Designation and Pediatric Rare Disease Designation for the treatment of this disease
.
Image source: Reference [2] In this multicenter, open-label, repeat-dose Phase 2b clinical trial, 23 patients with congenital HI who had not adequately controlled hypoglycemia with standard therapy were treated with RZ358 to evaluate Drug safety and tolerability, pharmacokinetics and glycemic efficacy
.
All patients were divided into 4 cohorts with doses ranging from 3 mg/kg to 9 mg/kg
.
The trial evaluated the effect of RZ358 on hypoglycemia by continuous blood glucose monitor (measurement of hypoglycemia time), and self-monitoring blood glucose by blood glucose meter (statistics of hypoglycemic events)
.
Nevan Charles Elam, CEO and Founder of Rezolute, said: "We are very encouraged by the trial results and look forward to advancing the program to Phase 3 to develop an innovative treatment option for this debilitating disease
.
"Disease Introduction: Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children
.
Usually presenting early after birth, about 60% of infants with congenital HI develop hypoglycemia within the first month of life
.
If not properly diagnosed and treated, serious brain damage and death can result
.
Over time, recurrent or cumulative hypoglycemia can lead to progressive and irreversible damage, including severe and devastating brain damage, seizures, neurodevelopmental problems, feeding difficulties, and adverse effects on the quality of life of patients and their families significant impact
.
The two most commonly used long-term drugs, diazoxide and somatostatin analogs, are not yet FDA-approved for all forms of the disease and can be associated with intolerable side effects
.
In cases of congenital HI that do not respond to medical therapy, surgical removal of the pancreas may be required
.
However, in patients with diffuse congenital HI affecting the entire pancreas, about half of the children will continue to develop hypoglycemia and require medical treatment despite surgical removal of nearly the entire pancreas
.
Reference: [1] Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism.
Retrieved March 23, 2022, from https:// /0/en/Rezolute-Announces-Positive-Results-from-the-Phase-2b-RIZE-Study-of-RZ358-in-Congenital-Hyperinsulinism.
html[2] Targeting rare and metabolic diseases with transformative therapies.
Retrieved March 23, 2022, from https:// Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
.
Trial data show that RZ358 can significantly improve hypoglycemia in patients with congenital hyperinsulinemia (HI), with good safety and tolerability
.
RZ358 is a humanized monoclonal antibody that binds to a unique stereogenic site on insulin receptors in liver, fat and muscle
.
The antibody counteracts the effects of elevated insulin in the body by regulating insulin binding, signaling and activity, thereby maintaining glucose levels within the normal range
.
Rezolute believes that RZ358 is well suited as a potential therapy for congenital hyperinsulinemia (HI), and other diseases characterized by excessive insulin levels
.
And, because RZ358 acts downstream of pancreatic islet β cells, it is expected to be broadly effective in the treatment of congenital HI caused by any underlying genetic defect
.
In addition, the US FDA has granted RZ358 Orphan Drug Designation and Pediatric Rare Disease Designation for the treatment of this disease
.
Image source: Reference [2] In this multicenter, open-label, repeat-dose Phase 2b clinical trial, 23 patients with congenital HI who had not adequately controlled hypoglycemia with standard therapy were treated with RZ358 to evaluate Drug safety and tolerability, pharmacokinetics and glycemic efficacy
.
All patients were divided into 4 cohorts with doses ranging from 3 mg/kg to 9 mg/kg
.
The trial evaluated the effect of RZ358 on hypoglycemia by continuous blood glucose monitor (measurement of hypoglycemia time), and self-monitoring blood glucose by blood glucose meter (statistics of hypoglycemic events)
.
Nevan Charles Elam, CEO and Founder of Rezolute, said: "We are very encouraged by the trial results and look forward to advancing the program to Phase 3 to develop an innovative treatment option for this debilitating disease
.
"Disease Introduction: Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children
.
Usually presenting early after birth, about 60% of infants with congenital HI develop hypoglycemia within the first month of life
.
If not properly diagnosed and treated, serious brain damage and death can result
.
Over time, recurrent or cumulative hypoglycemia can lead to progressive and irreversible damage, including severe and devastating brain damage, seizures, neurodevelopmental problems, feeding difficulties, and adverse effects on the quality of life of patients and their families significant impact
.
The two most commonly used long-term drugs, diazoxide and somatostatin analogs, are not yet FDA-approved for all forms of the disease and can be associated with intolerable side effects
.
In cases of congenital HI that do not respond to medical therapy, surgical removal of the pancreas may be required
.
However, in patients with diffuse congenital HI affecting the entire pancreas, about half of the children will continue to develop hypoglycemia and require medical treatment despite surgical removal of nearly the entire pancreas
.
Reference: [1] Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism.
Retrieved March 23, 2022, from https:// /0/en/Rezolute-Announces-Positive-Results-from-the-Phase-2b-RIZE-Study-of-RZ358-in-Congenital-Hyperinsulinism.
html[2] Targeting rare and metabolic diseases with transformative therapies.
Retrieved March 23, 2022, from https:// Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
