United BioPharma (UBP) today announced their latest results featuring unprecedented and unique functional characteristics of UB-221 monoclonal antibody in the phase I single-dose clinical trial, with chronic spontaneous urticaria (CSU) patients, to exhibit durable disease symptom relief. The results were published in the latest Journal of Clinical Investigation (JCI).
A New Treatment Option for CSU
The chronic spontaneous urticaria (CSU) has known to be caused by a type of protein or antibodies produced by the immune system, known as Immunoglobulin E (IgE).
While the existing approved CSU therapy (omalizumab; Xolair® ) and investigational drug (ligelizumab), have exerted positive reaction to reduce the disease symptoms over the last two decades, United BioPharma’s latest results have shown that the potential of a newer class of anti-IgE monoclonal antibody UB-221 has superior efficacy in CSU and can prolong the suppression of the disease symptoms.
In the study, UB-221 has proven to be a potent IgE neutralizer and a significant inhibitor of IgE neo-synthesis. Meaning, UB-221 binds IgE with a higher affinity and inhibits IgE production at a far greater scale in comparison with other anti-IgE antibodies like omalizumab and ligelizumab.
The study also suggests this new class of monoclonal antibody shows promise for the prevention of the development of allergic symptoms, through targeting both high-affinity IgE receptor (FcϵRI) and low affinity IgE receptor (CD23) pathways.
In addition, a notable observation of the study is that UB-221 in free form can interact unrestricted with CD23. This unprecedented feature not found in any other anti-IgE antibodies, supports the contention that it could be of benefit to target IgE toward the non-inflammatory CD23 pathway. In other words, UB-221 can down-regulate IgE production and reduce serum IgE levels in urticaria patients.
Other findings highlighted from the data published in the JCI include:
- In studies with animal models, such as cynomolgus macaques and human IgE (ε, κ)-transgenic hIGHE (immunoglobulin heavy epsilon)-knockin mice, a single dose of UB-221 can induce a rapid, profound reduction of serum IgE.
- The prolong suppression of urticaria symptoms and reduction of serum IgE levels suggests that a single dose of >2.0 mg/kg could potentially allow UB-221 to be administered every 3 to 6 months and achieve complete response (UAS7 = 0) or well controlled stage (UAS7 ≤ 6) in the treatment of CSU.
Advances in UB-221 for Allergic Diseases
Recent studies have shown that the combined prevalence of allergic diseases has increased to affect more than 30% of the world population. The condition underscores unmet medical need, burden on healthcare systems and the global economy as well.
In response to the situation, UB-221 is being developed as therapeutic biologics. It aims to treat various types of allergic (atopic) diseases, including chronic spontaneous urticaria, food allergy, atopic dermatitis, asthma, and allergic rhinitis.