UBI集團訊息
United BioPharma Files Phase IIb/III IND with the U.S. FDA for Treatment of Multi-drug Resistant HIV with Company’s Lead Product UB-421
In the completed phase IIa clinical trial, UB-421 has been demonstrated effective in reducing viral load in treatment naïve HIV patients. In subsequent phase II trial, UB-421 monotherapy was applied as substitution for highly active antiretroviral therapy (HAART or cART) and successfully maintains viral suppression in all treatment experienced patients during the study. The Company is confident that UB-421’s orthogonal treatment approach and its exceptional potency will help to overcome HIV drug resistance in MDR patients.
The Phase IIb/III trial is open labeled, randomized, multi-centered, and evaluated in two dose cohorts. The primary endpoint, defined as viral reduction after a single dose of UB-421, will quickly reveal the efficacy and benefits during the trial. For this specific indication, the Company plans to apply for orphan drug designation with the US FDA.
In addition to the indications for HAART substitution and treatment of multi-drug resistance, UBP plans to collaborate with NIH/NIAID to explore the functional cure application with UB-421, the ultimate goal in HIV treatment.
About United BioPharma (6471)
United BioPharma (UBP) was established in September 2013 as a spinoff from United Biomedical, Inc., Asia, and is strategically partnered with Formosa Plastics Group. UBP has an integrated monoclonal antibody drug development platform, and focuses on development, manufacturing, and marketing of innovative monoclonal antibody drugs and biosimilars. With a spirit of “innovation and practicality,” UBP is dedicated to addressing unmet medical needs, thereby improving the health of mankind and economic advancement of Taiwan. For more information, please visit http://www.unitedbiopharma.com
About UB-421
UB-421 is a humanized monoclonal antibody, which recognizes and binds to domain 1 of the CD4 molecule, the same site for HIV virus binding. This direct competition for binding to CD4 is termed competitive inhibition and effectively blocks the entry of HIV virus into CD4+ cells, thus inhibiting HIV infection. Competitive inhibition also prevents generation of drug resistance resulting from the mutation of the HIV virus.
UB-421 is an innovative antibody drug developed solely by United BioPharma (UBP). UBP has received Technology Development grants from the Taiwan government five times, won the Silver Prize in 2012 and Gold Prize in 2014 of the Pharmaceutical R&D Award. UBP also won the Gold Prize of the Taipei Biotech Award for its innovative R&D, and was selected as a Flagship Project and a Cross-Strait Pilot Program of Pharmaceutical Collaborative Development by the Taiwan FDA. UBP’s achievement in R&D and UB-421’s potential to treat AIDS have been repeatedly recognized.
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.