US-based biopharmaceutical firm Matinas BioPharma Holdings has started dosing in the first-in-human trial of its lead drug candidate MAT9001, designed to treat severe hypertriglyceridemia.
The company’s initial trial is being carried out in Canada and is a pharmacokinetic and pharmacodynamic (PK/PD) study of MAT9001 versus an active comparator.
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The PK/PD clinical trial will assess about 50 patients with an aim of showing better bioavailability than the active comparator.
Additionally, the company intends that the trial will provide data on MAT9001’s ability to yield distinctive therapeutic response properties and an improved therapeutic profile consistent with its preclinical trials.
Topline data from the PK/PD trial is expected to be reported in the second quarter of 2015.
Matinas BioPharma president and chief executive officer Roelof Rongen said: "Dosing of our first subject is a very important milestone for the company and for the advancement of MAT9001.
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By GlobalData"The commencement of the PK/PD study in Canada along with the recently filed IND in the US for our novel omega-3 drug candidate MAT9001 marks tremendous progress with the execution of our global development strategy and an important step forward as we prepare for the start of our Phase III registration programme of MAT9001 next year."
MAT9001 is a prescription-only omega-3 fatty acid medication including docosa-pentaenoic acid (DPA) and other omega-3 fatty acids, and it is specifically designed to provide a differentiated pharmacotherapy for the treatment of dyslipidemia.
The company said that promising pre-clinical studies with DPA and MAT9001 indicate distinctive therapeutic response properties.
