Lynk Pharmaceuticals has dosed the first subject in a Phase Ⅲ clinical trial of its JAK1 inhibitor, LNK01001, to treat rheumatoid arthritis (RA).
The double-blind, randomised, placebo-controlled trial will assess the safety and efficacy of LNK01001 to treat moderate-to-severe active RA with insufficient response or not tolerant to bDMARDs.
Peking Union Medical College Hospital and Chinese Academy of Medical Sciences professor Xiaofeng Zeng will lead the trial.
Lynk’s commercialisation partner Simcere Pharmaceutical will offer support to carry out the trial at various clinical study sites in China.
Lynk Pharmaceuticals chairman and CEO Dr Zhao-Kui Wan said: “The successful dosing of the first patient with LNK01001 in its Phase III study for the treatment of rheumatoid arthritis is an important milestone for our team and a key step towards providing innovative treatment options for patients with rheumatoid arthritis.
“We believe that the Phase III clinical trial of LNK01001 will further validate its efficacy and safety. We hope to have an opportunity to offer patients a better treatment option to improve their quality of life.”
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The JAK1 inhibitor has been analysed so far in three Phase II clinical trials to treat RA, ankylosing spondylitis (AS) and atopic dermatitis (AD) patients.
More than 800 participants across the world have received the LNK01001 treatment with nearly 100 individuals in a Phase I trial in Australia and over 600 with RA, AS or AD in China.
According to data from the concluded Phase II trials, the drug candidate showed to meet primary and secondary clinical endpoints.
Furthermore, LNK01001 was shown to have robust overall safety without any major adverse cardiovascular events, thrombosis, severe infections, or malignancy linked to other JAK inhibitors reported.
In March last year, Lynk and Simcere signed a strategic collaboration to commercialise the therapy.
Under this deal, Simcere obtained the sole commercial rights to supply the drug candidate for RA and AS indications in greater China.
In August, Lynk reported positive topline data from a Phase II clinical trial of LNK01001 in adults with AS.