Lynk Pharmaceuticals Co Ltd, a clinical-stage drug development company focused on immune and inflammatory diseases, announced on Tuesday the completion of patient enrolment in the Phase III clinical trial evaluating its core product zemprocitinib capsules for the treatment of active ankylosing spondylitis (AS).
The randomised, double-blind, placebo-controlled, multicentred clinical trial is designed to evaluate the efficacy and safety of zemprocitinib in patients with active AS. The primary endpoint is the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40% response (ASAS40) at Week 16. A total of 352 patients have now been enrolled, and the study is proceeding as planned with ongoing treatment, follow-up, and data collection.
According to Lynk, preclinical and clinical studies have shown that zemprocitinib potently and dose-dependently inhibits multiple JAK1-related inflammatory signalling pathways, supporting its therapeutic potential across multiple indications. Previously reported 24-week Phase III data in rheumatoid arthritis and 52-week Phase III data in atopic dermatitis demonstrated that zemprocitinib achieved the primary and key secondary endpoints, while showing rapid and sustained efficacy together with a favourable safety and tolerability profile. Rates of serious adverse events and adverse events of special interest (AESIs) were comparable to placebo, and laboratory safety parameters were also favourable.
Newbury Pharmaceuticals receives Swedish approval for generic tofacitinib
HDT Bio Launches Canadian clinical programme for brain cancer treatment
Lynk Pharmaceuticals reports first patient dosed in Phase II clinical trial for vitiligo treatment
AbbVie receives positive CHMP opinion for upadacitinib in severe alopecia areata
Evommune reports Phase 2b trial miss for EVO756 in chronic spontaneous urticaria
AbbVie receives positive CHMP opinion for upadacitinib in non‑segmental vitiligo
NeuroSense reports Phase 2 proof-of-concept study results for PrimeC in Alzheimer's Disease
Vascarta announces VAS-101 Phase I results in sickle cell disease patients
Cirius Therapeutics commences enrolment and dosing for Phase 2 study of CIR-0602K in type 1 diabetes
Kither Biotech completes Phase 1 KIT2014 clinical study
Gesynta Pharma reports progress in Phase 2 trial of vipoglanstat
Hillhurst Bio reports first subject dosed in Phase 2a trial of HBI-002 for Parkinson's disease
Organon secures FDA approval expanding TOFIDENCE indications for CRS and paediatric COVID-19