United BioPharma Receives China NMPA Approval for UB-421 Phase 3 ART-Substitution Trial in HIV-infected Patients
Taipei, Taiwan, May 13, 2019 -- United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a multi-nation, multi-center phase 3 clinical trial with UB-421 substitution monotherapy for HIV-infected adults who are on a stable treatment course of antiretroviral therapy (ART). The INDs of this trial had been approved earlier by Taiwan and Thailand regulatory agencies.
Of the estimated nearly 40 million people worldwide currently living with HIV, only half of those infected with HIV are being treated with ART. They are required to take ART drugs daily for life in order to maintain suppression of viral load at an undetectable level. The strict adherence to daily medication, fatigue from multiple drugs, and the associated social stigma remain a hurdle to overcome. In some patients, viral rebound occurs due to drug resistance, or are intolerable to the medication due to ART toxicity. Unmet medical need still exists for many HIV infected patients.
The current phase 3 trial is an extension study based on the results of the phase 2 ART-substitution trial, which was recently published in the April 18th issue of New England Journal of Medicine (NEJM), entitled “Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption.” The phase 2 study demonstrated UB-421 is safe and efficacious in sustaining HIV viral remission without drug-resistance viral rebound.
The phase 3 trial involves two cohorts of ART-stabilized patients, one cohort to continue their ongoing ART regimen as control, and the other cohort to switch to UB-421 monotherapy as an ART substitute by intravenous infusion at 25 mg/kg, bi-weekly for 26 weeks. After the treatment period, the study participants will return to the ART regimen and followed for an additional 22 weeks. The clinical protocol is designed to evaluate the long-term safety, efficacy, and capability of UB-421 as a substitution monotherapy.
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 currently in the stage of a multi-nation and multi-center clinical trial for ART substitution, as well as other trials for multi-drug resistance and proof-of-concept study of HIV functional cure.
About United BioPharma
United BioPharma (UBP) is a multi-national clinical-stage biopharmaceutical company dedicated to the research, development and manufacture of innovative and biobetter monoclonal antibody therapeutics for treatment of infectious, cancerous and immunological diseases. With R&D and manufacturing conducted at UBP’s headquarters in Hsinchu Industrial Park (Hukou), clinical research centered at the laboratories in Hsinchu Biomedical Park (Zhubei), and business operations at offices at Taipei 101, UBP is effectively positioned to employ its cutting edge and solid integrated technology platform and utilize its state-of-the-art research and manufacturing facilities to address unmet medical needs in mankind and to improve patient health and quality of life. UBP has its liaison offices in Long Island, New York; a research base for clinical development and regulatory affairs in Shanghai; a clinical laboratory, and pilot as well as commercial scale protein drug GMP manufacturing facilities currently being established in Yangzhou, China.
For more information, please visit http://www.unitedbiopharma.com
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Dr. Mei June Liao, Executive Vice President, Product Development
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