Lynk Pharmaceuticals has posted positive topline results from a Phase III trial on its next generation Janus kinase 1 (JAK1) inhibitor, zemprocitinib, in rheumatoid arthritis (RA).
During the late-stage study (NCT06276998), patients given 12mg, twice-daily oral zemprocitinib experienced a statistically significant improvement in disease activity, with 79.1% of patients achieving American College of Rheumatology 20% (ACR20) response after 24 weeks, compared with 39.7% in the placebo cohort, meeting the trial’s primary endpoint.
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ACR50 responses were seen in 41.4% of patients who received zemprocitinib compared with 9.3% ACR50 in the placebo group after 12 weeks.
Zemprocitinib’s ACR50 rate was stronger at 24 weeks, with 55.8% of patients reaching this milestone compared with the 22% in the placebo cohort.
Treatment with the JAK inhibitor also significantly improved disease activity score 28 (DAS28) values, with 67% of those receiving zemprocitinib reaching a score of ≤ 3.2 at week 24 compared with 23.4% in the placebo group.
DAS28 incorporates both clinician and patient-related factors to measure the RA disease activity across 28 specific joints prone to degradation in this disease, including overall wellbeing, inflammatory markers and joint tenderness.
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By GlobalDataThe effect of treatment with zemprocitinib was observed in patients who had previously exhibited inadequate responses to disease-modifying antirheumatic drugs.
Alongside its promising efficacy profile, zemprocitinib was found to be safe and tolerable, with most treatment-emergent adverse events (TEAEs) observed being mild-to-moderate in severity. The incidence of severe TEAEs was similar across the zemprocitinib and placebo arms.
While Lynk is yet to share specific safety data from this trial, the Chinese drug development company will present the primary results at an upcoming scientific conference.
In 2022, Lynk inked a deal with fellow Chinese pharma, Simcere, which saw the latter company claim the exclusive rights to market zemprocitinib across the ankylosing spondylitis (AS) and RA indications in China.
Creating the next generation of JAK inhibitors
In recent years, there has been some strong developments across the immunology sector, which has seen the introduction of novel, disease-modifying therapies that improve patients’ quality of life.
A particularly prevalent area of development for pharma companies is the JAK inhibitor. According to GlobalData, parent company of Clinical Trials Arena, there are 36 ongoing clinical studies involving JAK inhibitors within the RA indication alone.
It is no surprise that companies are looking to develop such therapies, as GlobalData forecasts that AbbVie’s best-selling JAK inhibitor, Rinvoq (upadacitinib) is set to bring in nearly $15bn in sales by 2031.
According to Lynk, zemprocitinib marks the next generation of JAK inhibitors, as the therapy exhibits high selectivity to JAK1. Because of this, Lynk theorises that zemprocitinib’s side effect and efficacy profile may be stronger than currently marketed JAK inhibitors.
However, it is unlikely that zemprocitinib will make it to US and European patients in the near-term, as the drug is currently only being developed in China.
GlobalData analysts predict that the RA market will be worth $2.9bn across the eight major markets (8MM: the US, Australia, France, Germany, Italy, Japan, Spain and the UK) in 2031.
