Stealth BioTherapeutics has begun the Phase I/II CHALLENGE-HD clinical trial of SBT-20 in the Netherlands to treat patients with early stage Huntington’s disease.

SBT-20 is an investigational tetrapeptide currently being developed to improve mitochondrial function for slowing down the neuronal degeneration and disease progression.

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The two-part, randomised, double-blind, placebo-controlled Phase I/II trial is currently being conducted at the Centre for Human Drug Research (CHDR) and is designed to assess the safety, tolerability and efficacy of various doses of daily subcutaneous SBT-20 in adult patients.

The trial will enrol a total of 24 patients who will participate in both parts of the trial.

Stealth BioTherapeutics chief executive officer Reenie McCarthy said: “The initiation of CHALLENGE-HD is a significant milestone for Stealth as our second drug candidate enters human trials in a new therapeutic area.

“We plan to use the results from this trial to better inform our SBT-20 pipeline development plan and the broader potential of our platform in neurodegenerative disorders.”

“As a leader in mitochondrial medicine, we want to pursue the full potential of mitochondria-targeted therapies, in rare primary mitochondrial diseases, common diseases of ageing and now in neurodegenerative disorders.

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“We plan to use the results from this trial to better inform our SBT-20 pipeline development plan and the broader potential of our platform in neurodegenerative disorders.”

The first part of the trial will include administration of one of three ascending doses of 5mg, 15mg and 25mg SBT-20 for seven days.

The data from this part of the trial will be used to choose a dose for administration in the second part for 28 days.

The primary endpoints of the trial are safety and tolerability, while the secondary endpoints include a measure of SBT-20’s effect on mitochondrial, motor function and pharmacokinetic profile.