Handok, under the leadership of CEO Kim Young-jin, has achieved a major milestone in the field of medicine. The European Medicines Agency (EMA) has granted priority medicines (PRIME) status to the treatment drug ‘RZ358’ for congenital hyperinsulinism. This recognition is reserved for new drugs that show potential benefits to patients in areas of unmet medical need, aiming to expedite their development and evaluation.
RZ358’s priority approval review was based on the successful outcomes of the phase 2b clinical trial known as ‘RIZE’ for congenital hyperinsulinism. The results were remarkable, with a 75% improvement in the incidence and duration of hypoglycemia. Moreover, the drug’s effectiveness in regulating blood sugar levels was observed across different age groups, including 2-6 years, 6-12 years, and 12 years or older.
Resolute’s Chief Regulatory Officer, Susan Stewart, expressed her delight with the PRIME status and highlighted the upcoming phase 3 clinical trial of RZ358, set to begin this quarter. She emphasized the positive impact that this treatment could have on patients and their families.
Chairman Kim Young-jin of Handok also expressed enthusiasm regarding RZ358, pointing out that its clinical results allowed for compassionate use in the United States for patients with refractory hypoglycemia caused by tumor-mediated hyperinsulinemia. He stated the potential of RZ358 to become a new treatment option for the severely limited options available for hyperinsulinism.
RZ358, developed by Resolute, is a monoclonal antibody specifically targeting the insulin receptor site. Its potential extends beyond the treatment of congenital hyperinsulinism and includes several other conditions characterized by excessive insulin production. The drug has been granted Orphan Drug Designation in the United States and Europe for congenital hyperinsulinemia, as well as Pediatric Rare Disease Designation in the United States.
The efficacy and safety of RZ358 in treating hypoglycemia have been verified in the RIZE clinical trial. Phase 3 clinical trials, set to take place in countries other than the United States and targeting participants over 3 months of age, are scheduled for the fourth quarter of this year.
Resolute, a bio venture specializing in rare and metabolic diseases, is dedicated to developing targeted treatments such as RZ358 for congenital hyperinsulinism and an oral diabetic macular edema treatment called ‘RZ402.’ Handok holds the domestic commercialization rights for both RZ358 and RZ402.
With these advancements, Handok and Resolute are poised to make significant contributions to the field of medicine, offering hope to those suffering from congenital hyperinsulinism and other related conditions.
Handok(CEO Kim Young-jin) is a related company. Determined(Decided) 의 congenital hyperinsulinism It was announced on the 18th that the treatment drug ‘RZ358 (development code name)’ has been given priority medicines (PRIME) status by the European Medicines Agency (EMA).
PRIME is awarded to new drugs that have demonstrated potential benefit to patients through clinical trials in areas of unmet medical need. It is designed to accelerate development and evaluation and strengthen support with the aim of bringing new treatments to patients more quickly.
RZ358 was granted priority approval review based on the results of the ‘RIZE’ phase 2b clinical trial for congenital hyperinsulinism. The clinical results showed that the incidence and times of hypoglycemia improved by about 75%. In addition, the effect of improving blood sugar levels appeared regardless of age, and was similar in patient age groups of 2-6 years, 6-12 years, and 12 years or older.
Susan Stewart, Resolute’s Chief Regulatory Officer, said: “We are delighted to have been granted priority review status ahead of the Phase 3 clinical trial of RZ358, which will commence this quarter. can recognize that RZ358 can have a positive impact on patients and their families through meaningful treatment effects,” he said.
Chairman Kim Young-jin of Handok said, “RZ358 shows promising clinical results, and in the United States last September, administration of RZ358 for patients with refractory hypoglycemia due to tumor-mediated hyperinsulinemia began under the compassionate use system for drugs .” “We expect that RZ358 may be a new treatment option for hyperinsulinism, for which treatment options are very limited,” he said.
Meanwhile, RZ358, which is being developed by Resolute, is a monoclonal antibody that acts on a specific site of the insulin receptor. It is being developed for the treatment of congenital hyperinsulin as well as a number of other diseases characterized by an excessive increase in insulin. RZ358 has been designated Orphan Drug Designation for the treatment of congenital hyperinsulinemia in the United States and Europe, and has also received Pediatric Rare Disease Designation in the United States.
The efficacy and safety of Rezolute in the treatment of hypoglycemia was confirmed in RIZE, a 2b clinical trial of RZ358 targeting patients with congenital hyperinsulinemia. In the fourth quarter of this year, phase 3 clinical trials targeting participants over 3 months of age are to be conducted in countries other than the United States.
Meanwhile, Resolute is a bio venture developing targeted treatments for rare and metabolic diseases. We are developing RZ358, a treatment for congenital hyperinsulinism, and ‘RZ402,’ an oral diabetic macular edema treatment. Handok holds the domestic commercialization rights for RZ358 and RZ402.
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