In the Phase II clinical trial, Biosion’s BSI-045B is being assessed to treat atopic dermatitis. Credit: NIAID/ Flickr (Creative Commons).

Clinical-stage biotechnology company Biosion USA has opened an investigational new drug (IND) after the US Food and Drug Administration review to commence a Phase II clinical trial of BSI-045B to treat atopic dermatitis (AD).

The trial has been designed for evaluating BSI-045B’s efficacy as monotherapy and along with Dupixent for further increasing the therapeutic effectiveness for AD patients.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The high-affinity, humanised monoclonal antibody (mAb) BSI-045B targets thymic stromal lymphopoietin (TSLP), which is a cytokine implicated in the pathogenesis of asthma, AD, as well as other eosinophilic and Th2 immune-related diseases.

In addition to excellent pharmacokinetic (PK), favourable safety profile, the monoclonal antibody showed potential to be a first-in-class treatment for AD, because of its single dose activity in an AD patients’ cohort, in a Phase I trial.

Biosion USA president and Biosion chief operating officer Dr Hugh Davis said: “BSI-045B is a next generation anti-TSLP mAb with high affinity and bioactivity that has the potential to offer greater therapeutic potential for patients with AD.

“Initiating the Phase II clinical trial is an important step toward our goal of developing antibody-based therapeutics for patients with unmet medical needs worldwide.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Currently, Chinese pharmaceutical firm CTTQ, the collaboration partner of Biosion, is also conducting a Phase II clinical trial of BSI-045B to treat severe uncontrolled asthma in China.

CTTQ holds the rights to develop and commercialise BSI-045B (TQC2731) in the country.