United BioPharma Received IND Approval from China NMPA for UB-621 Phase 2 Trial in Patients with Recurrent Genital Herpes
Taipei, Taiwan – November 10th, 2020 –United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a Phase 2 clinical trial with UB-621, an anti-HSV (Herpes Simplex Virus) monoclonal antibody, to evaluate its safety and efficacy in adults with recurrent genital herpes.
Earlier in an open label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous (SC) injection of UB-621 at doses ranging from 0.1 mg/kg to 5 mg/kg. In particular, UB-621 was found to have a remarkably long half-life of approximately 25 days. The current Phase 2 study is a randomized, single-blinded, placebo-controlled study to investigate the efficacy and safety of single dose UB-621 treatment for recurrent genital herpes.
Genital Herpes (GH) disease is a life-long HSV-2 infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections and is a leading cause of genital ulcers around the world. Patients with genital herpes often suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. Genital Herpes has been viewed as a significant global public health problem, as it can also intensify and exacerbate the transmission of human immunodeficiency virus 1 (HIV-1).
Currently, there are no effective vaccines against genital herpes and most of the current medications for genital herpes are generic nucleoside acyclovir analogues. Although there are several approved antiviral agents for treatment of GH outbreaks and for suppressive therapy, these antivirals are not always effective and can result in the development of drug resistance with prevalence of 0.1~0.6% in immunocompetent patients, and the staggering 3.5~10% in immunocompromised patients . Therefore, new interventions for effective prophylactic and therapeutic purposes are still urgently needed.
UB 621 is a novel, fully human monoclonal antibody that interferes with HSV infection by binding specifically to HSV envelope glycoprotein D (gD). It has been shown in vitro to block HSV infections of both wild type and acyclovir-resistant viral strains with over hundreds-fold higher potency. Our pre-clinical and early clinical data show that UB-621 has the potential to suppress recurrence of genital herpes.
UB-621, a fully human IgG1 monoclonal antibody, functions to block viral entry through binding to the surface envelope glycoprotein D (gD) of HSV, type I and type II. UB-621 has been demonstrated to exhibit a high-affinity binding (Kd, 3.6 × 10-11 M) to gD protein and a high potency against both HSV-1 and HIV-2 infections. UB-621 also shows capability to inhibit cell-to cell spread of HSV-1 and HSV-2 in vitro. Results in virus plaque reduction assays demonstrated that UB-621 is not only more potent than acyclovir (ACV) in inhibiting clinical HSV isolates of American and Asian origins, but also exerts marked neutralization activity towards ACV-resistant HSV strains from various sources. HSV disease animal model studies show that UB-621 exhibits both prophylactic and therapeutic activities, and can reduce severity of genital HSV-2 infection. In HSV infected mice model, UB-621can prevent virus transmission from eye infection site to neuron and to brain.
A subcutaneous (SC) liquid formulation of UB-621 has been demonstrated safe and well tolerated in healthy volunteers in a Phase I study. UB-621 exhibits a long half-life of approximate 25 days, which may allow a monthly or quarterly dosing scheme to treat HSV infection. UB-621 is entering a Phase II clinical study with patients suffering from recurrent genital herpes.
About Recurrent Genital Herpes
Genital herpes is a common sexually transmitted disease (STD) caused by herpes simplex virus type 1 or 2, but most are infected by herpes simplex virus type 2. There are approximately 500 million genital herpes patients around the world, 38% of them may have 6 or more recurrences per year and 20% of them may have more than 10 recurrences during the first year. When symptoms occur, small blisters are usually produced around the genitals or anus, and then the blisters break into superficial ulcers that become painful. Superficial ulcers would heal within about two to four weeks without leaving scars. However, symptoms of genital herpes may recur after weeks or months.
About United BioPharma
United BioPharma (UBP) is a clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to research, development and manufacturing of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou, China, and liaison offices in the U.S. The company has a global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the patients.
For more detailed information, please visit the website at: http://www.unitedbiopharma.com
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.
Dr. Mei June Liao, Executive Vice President, Product Development
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