US-based biotechnology company TRex Bio has begun dosing healthy volunteers in a clinical trial of TRB-061 for atopic dermatitis (AD).
TRB-061 is a tumour necrosis factor receptor 2 (TNFR2) agonist being developed to treat AD, which is also referred to as eczema.
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The drug activates and expands effector regulatory T-cells in the tissue and is claimed to restore immune balance in inflammatory conditions.
AD is an inflammatory skin condition marked by itching, impaired skin barrier function, and rashes.
The placebo-controlled, double-blind Phase Ia trial is designed to evaluate the drug’s tolerability, safety, pharmacodynamics (PD) and pharmacokinetics (PK) when administered subcutaneously in single ascending doses.
The trial is structured into three parts, beginning with cohorts of eight subjects being given single ascending doses of TRB-061 or placebo.
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By GlobalDataIn the second part, multiple ascending doses will be given every four weeks over an eight-week span to two cohorts of healthy subjects, while the third part will involve subjects with moderate-to-severe AD receiving one of two doses of the therapy or placebo for 12 weeks.
Subjects who respond to the treatment will have a 36-week follow-up, while those who do not will conclude the trial at the 16-week mark, with non-responders in the placebo cohort having the option to receive active treatment.
The trial is being carried out at one location in Australia and will include blood-based biomarker assessments to confirm early proof of mechanism.
Once it has been completed, TRex Bio plans to begin a Phase Ib proof-of-concept study in individuals with moderate-to-severe AD.
TRexBio CEO Johnston Erwin said: “We believe TRB-061 has the potential to be a best-in-class therapy with multi-indication application.
“Advancing TRB-061 into clinical development marks a significant milestone for the company and an important step in addressing the significant unmet needs of patients with atopic dermatitis and other inflammatory diseases.”
