Healthcare company Janssen Research & Development, LLC said on Tuesday that it has received encouraging results from a randomised, placebo-controlled Phase 2 study of the anti-interleukin (IL)-12/23 monoclonal antibody STELARA (ustekinumab) in the treatment of active systemic lupus erythematosus (SLE or lupus).
Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain. SLE can range from mild to severe and is characterised by inflammation of any organ system including kidneys, nervous system and brain.
The company added that the Phase 2 study study met the primary endpoint, with a significantly higher proportion of patients in the ustekinumab group showing improvements in lupus disease activity as measured by the SLE Responder Index (SRI)-4 response at week 24, compared with patients receiving placebo. About 60% of patients receiving ustekinumab showed significant reductions in lupus disease activity versus 31% of patients receiving placebo.
Under the Phase 2 study study, the patients were randomised (3:2) to receive intravenous (IV) ustekinumab 6 mg/kg or placebo (PBO) at week 0, followed by subcutaneous (SC) injections of ustekinumab 90 mg or placebo every eight weeks, both in addition to standard of care therapy for 24 weeks.
A pre-specified exploratory endpoint demonstrated that the risk of a new BILAG flare (at least one new BILAG A or at least two new BILAG B) was nominally significantly lower in the ustekinumab group compared with the placebo group. It plans to advance ustekinumab into Phase 3 development program based on Phase 2 results
In conjunction, the company is presenting the data as a late-breaking oral presentation at the 2017 ACR/ARHP Annual Meeting in San Diego.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Ono partners with Shattuck Labs for bifunctional fusion proteins
Artax Biopharma doses first subject in AX-158 Phase 2a psoriasis trial
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
BioSenic expands patent coverage for ATO therapeutic platform
Celltrion USA submits CT-P47 Biologics License Application to FDA
NS Pharma's NS-229 receives European Commission orphan drug designation
Kyverna Therapeutics' KYV-101 granted US FDA fast track designation
InnoCare Pharma receives U.S. FDA clearance for ICP-248 clinical trial
Biosenic finalises agreement with Phebra for oral arsenic troxide development
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Allorion Therapeutics signs exclusive option and global license agreement with AstraZeneca