US-based biopharmaceutical company Sudo Biosciences has initiated a Phase I trial of SUDO-550, a drug candidate designed to treat neuroinflammatory diseases.
The trial aims to assess the drug’s tolerability, safety and pharmacokinetics, including its ability to cross the blood-brain barrier.
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It will involve both single and multiple-ascending doses being given to healthy volunteers.
SUDO-550 is an allosteric tyrosine kinase 2 (TYK2) inhibitor that is orally administered and designed to be highly selective and potent, minimising off-target effects.
In non-clinical studies, the drug has shown potential in blood-brain barrier penetration, which is crucial for treating central nervous system (CNS) diseases marked by compartmentalised neuroinflammation.
Sudo Biosciences chief medical officer Ian Mills said: “Entering the clinic is a critical step in the development of SUDO-550 and establishing it as a best-in-class brain-penetrant TYK2 inhibitor.
“This is a therapy that could significantly advance the treatment of diseases such as multiple sclerosis, amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease.
“This is the second allosteric TYK2 inhibitor we have advanced into the clinic this year, after SUDO-286, which is progressing in two Phase I trials as a topical treatment for psoriasis.”
SUDO-286 is being evaluated as a topical TYK2 inhibitor for psoriasis and other immune-mediated dermatologic diseases.
This programme is currently undergoing two Phase I trials in healthy volunteers and subjects, having entered the clinic earlier this year.
Based in Indiana, Sudo Biosciences focuses on the TYK2 pseudokinase domain, a crucial mediator in cytokine signalling pathways associated with a range of immune-mediated inflammatory conditions.
Last year, the company raised $116m in a Series B financing round jointly led by Enavate Sciences and TPG.
The funding round increased Sudo Biosciences’ total funding to $157m since its establishment in 2020.
The company has allocated these funds for advancing its investigational TYK2 candidates.
