United BioPharma Filed IND to Taiwan, China and Thailand FDA for UB-421 Phase III HAART Substitution Study

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United BioPharma (UBP, 6471) announced that the company recently received the approval from Taiwan FDA an IND (Investigational New Drug) application for a multi-nation, multi-center, Phase III clinical trial with UB-421 monotherapy as HAART substitution in HIV infected patients.  The subsequent filing of IND to China and Thailand has also been completed.

According to WHO, there are approximately 37 million people infected with HIV around the world currently. Among them, about 19.5 million persons are using highly active antiretroviral therapy (HAART) and those who are stably taking HAART to control the blood HIV at the undetectable level are the target population of this trial. 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 25mg/Kg, bi-weekly for a treatment period of 26 weeks. The subjects will be grouped into tow cohorts, one cohort will continue the original HAART treatment alone and the other cohort will switch to receive UB-421 as the monotherapy for 26 weeks. After the treatment period, subjects in both cohorts will return to HAART and followed for another 22 weeks.

According to the market report, the main reason that the clinicians switch anti-HIV drugs for patients is that most patients prefer simpler and less frequent treatment regimens. In addition, the current anti-retroviral therapy some with serious side effects affects patient’s quality of life greatly. Furthermore, the drug resistance to HAART is also a common problem.

Compared to the current HAART in which the patients need to take medicines daily for a life time, many patients are willing to try novel anti-HIV drugs that only need to be taken weekly or monthly and with milder side effects. If bi-weekly UB-421 monotherapy are clinically proven to replace HAART, it is for sure a simpler and more favorable therapy to the 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 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 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.

 

 

Contact:

Victor Run-Ben Sun

Spokesperson and Vice President of Administration & Legal Affairs

+886-3-6684800 # 3808

victor.sun@unitedbiopharma.com

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