resTORbio has completed dosing patients in a Phase IIb trial examining the safety, tolerability, and efficacy of RTB101 alone or in combination with everolimus to treat respiratory tract infections (RTIs).
A total of 652 elderly patients aged 85 and above or 65-84 years with comorbidities and at increased risk of RTI-associated morbidity and mortality have been enrolled in the trial.
The randomised, double-blind placebo-controlled trial includes two parts. One enrolled elderly subjects during the winter cold and flu seasons in the southern, while the second part enrolled patients in northern hemispheres.
Part two of the trial began in the US in the fourth quarter of last year after an interim analysis of results from the first stage.
This part is a four-arm trial comparing placebo to 10mg of RTB101 given once-daily (QD), 10mg of RTB101 dosed twice-daily (BID), or 10mg of RTB101 and 0.1mg of everolimus dosed QD.
All patients were treated with RTB101 for 16 weeks, followed by eight weeks of follow-up.
Topline data from the trial is expected to be released in the third quarter of this year.
resTORbio president and CEO Chen Schor said: “RTIs are a leading cause of hospitalisations and death among the elderly and are mainly caused by viruses that lack effective treatments.
“Selective TORC1 inhibition has the potential to improve the function of the ageing immune system and thereby reduce the incidence of RTIs, regardless of the causative pathogen, representing a new paradigm for meeting the needs of at-risk elderly patients.
“Increasing scientific data suggest that TORC1 inhibition also has the potential to improve the function of other ageing organ systems.”
resTORbio intends to develop RTB101, an orally administered, selective TORC1 inhibitor, for additional ageing-related indications including heart failure or neurodegenerative diseases.