United BioPharma (UBP, 6471) announced today that the company receives the approval from Thailand FDA an IND (Investigational New Drug) application for a multi-nation, multi-center, Phase III clinical trial with UB-421 monotherapy as HAART (Highly Active Anti-retroviral Therapy ) substitution in HIV infected patients.
The phase III trial is a randomized, open-label, controlled trial to investigate the efficacy and safety of UB-421 monotherapy as substitution for stable antiretroviral therapy in HIV-infected adults. Subjects will receive UB-421 by intravenous infusion at 25 mg/Kg, bi-weekly for a treatment period of 26 weeks. The subjects will be grouped into two cohorts, one cohort will continue the original HAART treatment as control and the other cohort will switch to receive UB-421 monotherapy for 26 weeks. After the treatment period, subjects in both cohorts will return to HAART and followed for another 22 weeks. The primary objective of this phase III trial is to evaluate the ability of UB-421 monotherapy in maintaining viral suppression in HIV patients who are stable on HAART.
There are approximately 37 million people infected with HIV around the world currently. Among them, about 19.5 million persons are using HAART to control the HIV viral load. To keep the virus suppressed, these patients are required to take HAART for life time. In addition, the side effects of anti-retroviral chemical drugs often lead to poor compliance of treatment and development of drug resistance. The company expects that biweekly administration of UB-421 can substitute the daily dosing of HAART and provide a more convenient and safer treatment for HIV patients.
About United BioPharma (6471)
UBP was established in September 2013 as a spinoff from United Biomedical, Inc., Asia, and is strategically partnering 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 execution,” 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
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 UBP. UBP has received the Technology Development grants from 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.
Victor Run-Ben Sun
Spokesperson and Vice President of Administration & Legal Affairs
+886-3-6684800 # 3808