The Sareum Holdings Plc (LON: SAR) share price rose 6.58% after announcing that it had started dosing the first subjects in the multiple ascending dose part of its Phase 1a clinical trial for lead drug candidate SDC-1801.
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SDC-1801 is being developed to treat autoimmune diseases and cancers, with the company’s current focus being psoriasis, an autoimmune disease affecting the skin. The drug safety committee approved the Phase 1a trial after analysing preliminary data generated from the first three cohorts in the single ascending dose part of the study.
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The dosing is being conducted at a specialist clinic in Melbourne, Australia, and the subjects will receive SDC-1801 orally once daily for 10 days. The safety review committee saw that the data from the first three cohorts was adequate to allow the multiple ascending dose part of the study to begin.
SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being created as a potential new treatment for a range of autoimmune diseases. The Phase 1a trial is meant to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of an oral formulation of SDC-1801 in healthy participants.
The clinical trial is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. The trial has three parts, the first being a single ascending dose study (Part 1), the second being a multiple ascending dose study (Part 2), and the third being a food effects study (Part 3).
The safety and pharmacokinetics data from the first cohorts of Part 1a clinical study indicate a favourable safety profile and fully support the oral dosing of patients once daily.
Sareum’s CEO, Dr Tim Mitchell, commented: “We are delighted that the data generated to date supports the safety review committee’s approval to begin dosing the first subjects in the multiple ascending dose part of our Phase 1a trial of SDC-1801. Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated that will be available upon completion of this part of the trial.”
Sareum share price.
The Sareum share price rose 6.58% to trade at 82.60p, from Friday’s closing price of 77.50p.
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