Landos Biopharma has published data from the Phase Ib NEXUS clinical trial investigating NX-13 in patients with ulcerative colitis (UC).
The majority of the subjects treated with the drug reported consistent and rapid clinical improvement in symptoms, as measured by rectal bleeding and stool frequency, and endoscopic improvement after four weeks. NX-13 was well tolerated in all patients.
The data from the clinical trial was published in the Journal of Crohn’s and Colitis on 21 November.
In the announcement accompanying the data, lead author Bram Verstockt said: “Despite advances in UC treatments, the need for new and novel therapies such as NX-13 remains highly important for patients. The early signs of efficacy, along with a favourable safety profile, highlighted in this publication are encouraging.”
The Phase Ib placebo-controlled, randomised, multicentre study (NCT04862741) evaluated the clinical activity, safety, and pharmacokinetics of NX-13, an oral NLRX1 agonist, as a treatment for ulcerative colitis.
The study randomised 38 patients into NX-13 immediate-release doses 250mg and 500mg, 500mg of delayed-release dose of NX-13, and placebo.
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NX-13 is currently being evaluated in the Phase II study (NCT05785715) with topline results expected in Q4 2024. The study plans to enrol 80 patients with a long-term extension (LTE) period in patients with moderate to severe UC.
The patients are randomised into three groups where they will receive either a 250mg dosage of NX-13 plus two placebo tablets, three tables of 250mg of NX-13 or a placebo. The primary outcome of the study is evaluating the clinical activity of NX-13 versus placebo.
Landos has other UC drugs in the late-stage pipeline such as omilancor (BT-11), a LANCL2 receptor agonist. The company recently published positive data from its Phase II trial (NCT03861143) that is evaluating this candidate. The trial was completed in June 2021 after the US Food and Drug Administration (FDA) accepted Landos’ investigational new drug application (IND) in June 2018.
UC is an inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, specifically the innermost lining of the large intestine. According to a report on GlobalData’s Pharma Intelligence Centre, UC drug sales are forecast to increase to $10bn across the eight major markets, which include the US, France, Germany, Italy, Spain, UK, Japan, and Canada, by 2031.
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