Successful Unblinding of the Phase III Clinical Trial of Erythropoietin Conducted by UBI Pharma, a Subsidiary of United Biomedical
Hsiao-Chen Shen ｜ Taipei ｜ PUBLISHED: June 11, 2021 at 7:29 p.m.｜ Anue
UBI Pharma, a subsidiary of United Biomedical, announced today (June 11th) that the unblinding of the interim data of the phase III clinical trial of erythropoietin UBI-851 has been completed, and the mean change in the hemoglobin levels as the primary efficacy endpoint was statistically significant and met expectations for the trial. The application for drug license in Taiwan will be submitted thereafter.
The erythropoietin UB-851 developed by UBI Pharma Inc. is indicated for treating renal anemia. The phase III clinical trial enrolled 204 patients with renal anemia undergoing dialysis, and the reference drug selected was Eprex.
UBI Pharma stated that the results of the phase III clinical trial showed that the primary efficacy endpoint, the mean change in the hemoglobin levels, and the mean change in the weekly dose of erythropoietin were statistically significant, suggesting that treatment with UB-851 is equivalent in effectiveness to treatment with Eprex.
In terms of secondary efficacy endpoints, UBI Pharma stated that no statistically significant difference was found between UB-851 and the reference drug in the frequency of blood transfusions and maintenance of the hemoglobin levels in subjects, indicating that the similarity defined in the trial design and statistics had been reached. As for clinical safety, no subject reported adverse reactions; in addition, the degree of reaction and frequency of occurrence were very similar to those of the reference drug, and the endpoints all met expectations for the trial.
UBI Pharma stated that the unblinding of the interim data for the phase III clinical trial of UB-851 has been completed, and an application for the registration of a biosimilar drug in Taiwan will be submitted to the TFDA subsequently.
According to statistics released by research institutes, the size of the global erythropoietin market reached US$9.24 billion in 2020. The market size is expected to reach US$11.41 billion by 2028 with a compound annual growth rate of 5.7% from 2021 to 2018.