Zura Bio has initiated the double-blind Phase II TibuSURE trial to assess the humanised tetravalent bispecific dual-antagonist antibody, tibulizumab, in treating systemic sclerosis (SSc), also referred to as scleroderma, in adult patients.
The global placebo-controlled trial involves nearly 80 subjects with early diffuse cutaneous systemic sclerosis (dcSSc).
Go deeper with GlobalData
It includes an efficacy period of 24 weeks followed by a 28-week open-label extension.
Modified Rodnan Skin Score (mRSS) is the primary endpoint and it also focuses on key efficacy endpoints such as lung disease through quantitative high-resolution computed tomography (qHRCT) and forced vital capacity (FVC), physical function via the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the revised Combined Response Index in Systemic Sclerosis (rCRISS).
Zura Bio Development head and chief medical officer Kiran Nistala said: “Single-pathway inhibition has demonstrated modest effects in rheumatic diseases like SSc. This is why we believe tibulizumab’s dual-pathway approach holds the potential to be best-in-class, aiming to provide deeper efficacy and greater benefits for patients affected by this life-threatening autoimmune disease.
“The initiation of the TibuSURE study marks a significant milestone in addressing certain urgent, unmet needs of this patient population and advancing our mission to improve the lives of those affected by autoimmune and inflammatory conditions.”
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.
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 GlobalDataTibulizumab combines Taltz (ixekizumab) and tabalumab to neutralise IL-17A and BAFF. The therapy is under investigation in this Phase II trial for SSc and is anticipated to enter a Phase II study for hidradenitis suppurativa next year.
Prior to being in-licensed, tibulizumab underwent Phase I/Ib studies for other autoimmune conditions, including rheumatoid arthritis and Sjögren’s syndrome.
As an investigational compound, it is yet to receive marketing approval from the Food and Drug Administration (FDA) or any other regulatory body.
Alongside tibulizumab, the company’s portfolio includes crebankitug (ZB-168) and torudokimab (ZB-880).
