Top-line data support Phase 3 trial of LNK01001 in hard-to-treat AS

Phase 2 trial: LNK01001 reduced inflammation in adults with active disease

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by Steve Bryson PhD |

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An experimental therapy called LNK01001 can safely lower a measure of inflammation, pain, and stiffness in adults with active ankylosing spondylitis (AS) who were refractory or intolerant to non-steroidal anti-inflammatory drugs.

These top-line data from a 12-week Phase 2 clinical trial support moving LNK01001 to a Phase 3 trial, according to the therapy’s developer, Lynk Pharmaceuticals.

“Ankylosing spondylitis is a chronic inflammatory disease primarily affecting the spine and sacroiliac joints,” Xiaofeng Zeng, MD, the trial’s principal investigator, from the Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, said in a company press release. “Controlling or reducing inflammation, relieving pain, and stiffness are the main treatment goals.”

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Phase 3 trial to validate efficacy and safety of LNK01001

“LNK01001 has demonstrated both efficacy and safety in this study, and we look forward to further validating its efficacy and safety in Phase III clinical trials to benefit more patients,” Zeng said.

AS is a type of arthritis that affects the joints of the spine, as well as the sacroiliac joints, where the base of the spine meets the pelvis. Symptom onset, such as back pain and stiffness in the lower back and hips, typically occurs in early adulthood and gradually worsens, but severity can vary from person to person.

“Ankylosing spondylitis, which predominantly affects young and middle-aged individuals, significantly impairs patients’ mobility and quality of life,” said Henry Wu, PhD, Lynk’s chief development officer. “There are still many unmet treatment needs in the existing therapeutic approaches.”

LNK01001 is designed to block the action of Janus kinase 1 (JAK1), a protein that plays a key role in inflammation. Its goal is to reduce inflammation in multiple inflammatory diseases, including AS.

The Phase 2 study enrolled 177 adults diagnosed with AS who were randomly assigned to a high or low dose of LNK01001, or a placebo, for 12 weeks (nearly three months).

Phase 2 trial met goal, with more treated patients achieving ASAS40 response

The trial met its primary goal, with significantly more patients in both LNK01001 dose groups achieving an ASAS40 response compared with the placebo at 12 weeks. An ASAS40 response requires at least a 40% improvement in a minimum of three out of four assessment domains: inflammation, pain, function, and global patient assessment.

Treatment benefits were rapid, the company said, with patients in both LNK01001 dose groups showing improvements from the second week.

“We are pleased to witness LNK01001’s positive outcomes in this study,” Wu said. “The company has recently submitted an End of Phase II (EOP2)/Pre-Phase III meeting application and is actively advancing the Phase III clinical trial of LNK01001 for the treatment of ankylosing spondylitis, aiming to provide an improved treatment option for patients.”

Treatment was well tolerated, with most treatment-emergent adverse events (TEAEs) being mild to moderate (grade 1-2). Severe or life-threatening TEAEs (grade 3 or above), discontinuations, or serious adverse events were low and comparable to the placebo. No major heart or blood vessel complications were reported.

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LNK01001 being tested in clinical trials for other inflammatory diseases

Lynk is also testing LNK01001 in clinical trials enrolling people with other inflammatory diseases, including rheumatoid arthritis and atopic dermatitis (eczema).

“As a highly selective JAK1 inhibitor, LNK01001 has successfully completed multiple Phase Ib and Phase II clinical trials in almost 600 patients for three indications (rheumatoid arthritis, atopic dermatitis, and ankylosing spondylitis) with about 800 subjects exposed to LNK01001,” said Zhao-Kui Wan, PhD, Lynk’s chairman and CEO. “All studies conducted have shown promising results up to date.”

“We are delighted to observe the significant efficacy and favorable safety profile demonstrated by LNK01001 in these studies,” Wan added. “We are gearing up to initiate Phase III clinical trials for LNK01001 in the near future to accelerate the clinical development and regulatory process for this product, and at the same time to explore the potential of additional indications.”