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United BioPharma Receives IND Approval from TFDA for A Phase 2 Study of UB-221 in Adults with Chronic Spontaneous Urticaria

United BioPharma (UBP) announced today that the Phase 2 clinical trial of a novel anti-IgE monoclonal antibody UB-221 has been approved by Taiwan FDA to proceed. Patients with chronic spontaneous urticaria (CSU) who failed the 1st and 2nd-line treatment will receive two intravenous infusions of UB-221 at an interval of 3 months (long-acting usage) to evaluate the pharmacokinetics, pharmacodynamics, safety and efficacy of UB-221.

In the phase 1 clinical trial with participants of moderate to severe CSU who were followed up to 99 days after a single dose of UB-221 (6 or 10 mg/kg) as an add-on therapy, the participants’ serum IgE levels diminished quickly and maintained at undetectable level till the end of the study. Also, the scores for itch and hives (UAS7) decreased significantly in the first week after UB-221 administration. The therapeutic effect reached to 99 days or longer, implying that, a single dose of UB-221 could significantly or completely relieve the symptoms of the disease for more than three months.

The forthcoming Phase 2 clinical trial (double-blind, placebo-controlled) aims to evaluate the safety and efficacy of UB-221 as a long-acting add-on therapy. This trial is planned to enroll 25 of moderate to severe CSU patients and randomly divide the participants into two treatment groups (5 and 10 mg/kg) and one placebo group at a ratio of 2:2:1 with two intravenous infusions at an interval of 12 weeks (three months). It is expected that this trial is able to provide the evidence showing the therapeutic potential of two high-dose UB-221 treatments over a 6-month period or longer.

About UB-221
UB-221 is a humanized IgG1 that targets the Cε3 domain of IgE antibody. UB-221 is not only able to neutralize free/soluble IgE, but also to inhibit the IgE synthesis by binding to FcεRII (CD23) receptor on B cells surface. According to preclinical studies, UB-221 is superior to currently marketed therapeutic antibody targeting IgE (Xolair® ; Omalizumab) by 8-folds in terms of pharmacological effects. UB-221 shows 2 to 5-folds inhibition of IgE synthesis than Xolair® in the in vitro study. UB-221 only takes a 1/10 dose to achieve the same effect of Xolair® in huIGHE-knock-in mice model. A PK study in cynomolgus monkeys demonstrated UB-221 has a longer serum half-life (~11 days with SC administration) than Xolair®.

According to the results of phase 1 clinical trial, CSU patients treated with a single dose of UB-221 responded quickly and their free IgE in the serum were suppressed for weeks to months.  UB-221 effectively relieved the symptoms of chronic spontaneous urticaria (CSU) in all trial participants. In In vitro studies, UB-221 is able to inhibit the production of new IgE by binding to the IgE already bound on the low-affinity receptor CD23 (FcεRII). This is a unique IgE binding property not shared by Xolair®, the only anti-IgE mAb approved for clinical use. Since UB-221 can curb the synthesis of IgE, the speed of IgE rebound will be slower than that of Xolair® after the treatment is discontinued. The highest dose of UB-221 administered intravenously in phase 1 clinical trial has a long half-life up to 22 days. Potential indications of UB-221 include IgE-mediated allergies, such as chronic spontaneous urticaria, allergic asthma, allergic rhinitis, food allergies, and atopic dermatitis. UB-221 is with a great potential for application.

About Chronic Spontaneous Urticaria (CSU)
Spontaneous urticaria is categorized into acute (less than six weeks) and chronic (more than six weeks) spontaneous urticaria. Chronic spontaneous urticaria (CSU) is also formerly known as chronic idiopathic urticaria (CIU) and chronic urticaria (CU). With the incidence rate of 0.5–1%, patients are suffered from the disease at any time. Although all age groups can be affected, peak incidence has been observed between 20 and 40 years of age. CSU brings tremendous detrimental effects on quality of life, such as sleep deprivation and psychiatric comorbidity. CSU also has a large impact on the economy in terms of direct and indirect health care costs as well as reduced performance at work. In the majority of CSU patients, an underlying cause cannot be identified, making a causal and/or curative treatment difficult. Nonsedating H1‐antihistamines are the mainstay of symptomatic therapy, however treatment with licensed doses relieves symptoms effectively in <50% of patients. Although guideline‐recommended updosing up to fourfold increases symptom control in many patients, a substantial number of patients only benefit a little from H1‐anti-histamine medication. Hence, there is still a great need for new therapeutic strategies.

 (Reference: Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GALEN task force report. Allergy. 2011;66 (3):317-330).

About United BioPharma 
United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP is headquartered in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has a highly passionate global team, developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable treatments to bring a better quality of life to patients. For more information, please visit the website at: 

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.

Company contact:
Dr. Mei June Liao, Executive Vice President, Product Development

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