Tisento Therapeutics has dosed the first subject in its Phase IIb PRIZM study, examining the effects of the oral investigational therapy, zagociguat, on mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS), a rare mitochondrial condition.
The trial is designed to assess the therapy’s influence on cognitive impairment, fatigue, and other significant disease aspects.
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It is designed with patient convenience in mind, offering at-home evaluations, the possibility of home visits, and travel support.
Subjects will receive both zagociguat and placebo treatments in the single period of the crossover study and may access an open-label extension upon completion.
The assessments of clinical outcomes and strategy of endpoints of the study are based on the company’s interview study with patients who have MELAS, ensuring the trial addresses the impactful symptoms and disease effects as reported by the patients themselves.
Enrolment for the study, which is currently open across Europe, Australia, and North America, will explore the efficacy and safety of once-daily zagociguat at doses of 15mg or 30mg over a 12-week period, against a placebo.
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By GlobalDataTisento Therapeutics CEO Peter Hecht said: “Since Tisento’s founding, we have been focused on initiating a thoughtful, well-designed clinical study to evaluate zagociguat for the treatment of MELAS, and we are humbled by the enthusiastic response we have received from physicians and the mitochondrial disease community.
“We are pleased that the first participants are enrolling in the global PRIZM study, which was designed with patient perspectives at the forefront. We will continue to put patients first every step of the way as we work to develop creative solutions to address what matters most for people with serious diseases.”
Zagociguat is designed to positively affect both the peripheral and central nervous system manifestations of mitochondrial diseases by stimulating soluble guanylate cyclase, an enzyme crucial for neuronal function and blood flow.
