UBI集團訊息
United BioPharma Received IND Approval from China NMPA for a Phase 3 Trial with UB-421 in Patients with Multi-Drug Resistance (MDR) HIV-1 infection
United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) to conduct a Phase 3 clinical trial with UB-421, an anti-CD4 monoclonal antibody, in patients with multi-drug resistant (MDR) HIV-1 infection. The study is a multi-nation trial which will include Taiwan and China; the same protocol was approved earlier this year by TFDA.
A majority of people living with HIV can be successfully treated with combined antiretroviral therapy (ART); however, a subset of patients develop resistance to multi-drugs or multi-drug classes, and are unable to tolerate a regimen that could suppress HIV-RNA to undetectable levels. With very limited treatment options, these patients are at a higher risk of HIV-related complications and progression to AIDS. The MDR patients are in vital need of a new treatment that is relatively safe, and without drug-drug interactions or cross-resistance.
In this multi-nation Phase 3 trial, a total of 50 HIV-infected patients who are highly treatment- experienced with resistance to multi-classes of antiretroviral agents will be enrolled. The protocol is designed according to US FDA guidance to evaluate the primary efficacy endpoint (at least 0.5 log reduction of HIV RNA achieved) within 2 weeks, followed by a maintenance phase of 24-weeks to assess the secondary efficacy and safety endpoints. The dosing regimen of UB-421 is 25 mg/Kg bi-weekly via intravenous (iv) administration.
About UB-421
UB-421 is an Fc-aglycosylated, non-T cell depleting and CD4-specific humanized IgG1 derived from the parent murine B4, which binds to discontinuous, conformational epitopes on the HIV-receptor complex, including CD4 (domain 1), and competitively blocks HIV entry. Both the murine and humanized mAbs bind to CD4+ T cells with approximately 50-100-fold higher affinity than HIV-gp120. UB-421 has been shown to inhibit viral entry with remarkable viral load reduction potency in Phase 1 and Phase 2a clinical studies involving treatment-naïve HIV-infected patients. In the Phase 2 study with ART-stabilized HIV-infected patients, UB-421 monotherapy maintains viral suppression for up to 16 weeks without viral rebound in the absence of ART. UB-421 is entering a multi-nation, multi-center clinical trial for ART substitution, as well as other trials for HIV multi-drug resistance (MDR) and proof-of-concept study of HIV functional cure.
About United BioPharma
United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP is headquartered in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has a highly passionate global team, developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable treatments to bring a better quality of life to patients.
United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.