Lynk hits main goal for ankylosing spondylitis to wrap up clean sweep of phase 2 JAK trials
23 Aug 2023
Phase 2Phase 3Drug Approval
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Source: FierceBiotech
Lynk Pharmaceuticals plans to run a phase 3 trial in ankylosing spondylitis.
Lynk Pharmaceuticals has completed a clean sweep of midphase clinical trials. Having reported primary endpoint hits in two indications earlier this year, the Chinese biotech has maintained its pristine record by linking the JAK1 inhibitor LNK01001 to improvements in adults with active ankylosing spondylitis (AS).
The phase 2 development program for LNK01001 targeted three indications: rheumatoid arthritis, atopic dermatitis and AS. Lynk shared news that the rheumatoid arthritis study had met its primary endpoint in May, prompting it to start preparing for phase 3, and followed up with news that the drug candidate beat placebo in atopic dermatitis earlier this month.
Those back-to-back victories left Lynk needing to move the needle in AS, a type of arthritis that causes inflammation in the spine, to achieve a 100% success rate in phase 2. Lynk revealed the AS trial went the same way as the earlier studies Wednesday morning.
The latest trial randomized 177 people with AS who were failed by nonsteroidal anti-inflammatory drugs to receive one of two doses of LNK01001 or placebo. After 12 weeks, Lynk saw a statistically significant difference over placebo in the proportion of patients in both treatment arms who experienced a 40% or greater improvement on an AS symptom scale.
On the safety and tolerability front, Lynk reported that the rate of treatment-related discontinuations and serious adverse events over the first 12 weeks was low in both LNK01001 cohorts and comparable to the control group. No patients across the entire 24-week trial experienced major adverse cardiovascular events, venous thromboembolism or severe safety events such as malignancies.
The AS press release, like the earlier statements on rheumatoid arthritis and atopic dermatitis, lacks any numbers to show how well LNK01001 performed compared to placebo. The details matter, because Lynk is far from the only company targeting the indications. AbbVie’s JAK1 inhibitor won FDA approval in AS last year and has racked up authorizations in a handful of other indications in China, Lynk’s home market.
While Lynk is yet to share AS data, its actions indicate belief in the candidate. The biotech plans to run a phase 3 trial in AS, making the indication part of its multifront, late-stage push. Lynk is focusing its work on China and, with EQRx walking away from ex-China rights earlier this year, has previously discussed its desire to partner the program in global markets.
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