resTORbio Inc. (NASDAQ:TORC) has initiated a randomized placebo-controlled double-blind study of RTB101, which is an orally-administered powerful small-molecule target inhibitor of rapamycin complex relative to the placebo for coronavirus prophylaxis for residents in nursing homes.
RTB101 has the potential of reducing the severity of COVID-19 infections
The study will be supported by data collected from the company’s Phase2b and third Phase clinical trials that have shown the potential of RTB101 reducing the severity of lab-confirmed COVID-19 infections. resTORbio disclosed that it had previously conducted two RTB101 trials to prevent respiratory tract infections in adult patients above 65.
In the Phase 2b RBT101 study, around 652 patients with comorbidities that increase RTIs risk, 10mg of RTB101 was administered once per day and was seen to upregulate the distinctive antiviral gene expression and also minimized incidence in lab-confirmed RTIs by 30%. The second study, Phase 3 involved around 1,024 non-smoking subjects without COPD that didn’t meet the primary endpoint of preventing respiratory symptoms consistent with RTI, which received 10mg of RTB101.
resTORbio to evaluate coronavirus prophylaxis with RTB101
In the two trials, RTB101, which was administered once per day, was tolerated well and resulted in a reduction of incidence and severity of coronavirus infections relative to placebo. Currently, the company is conducting trials of RTB101 is COVID-19 prophylaxis in adults. The new study aims to evaluate if COVID-19 prophylaxis with RTB101 relative to placebo can minimize the severity of lab-confirmed coronavirus in adults above 65 years residing in a nursing home where there has been a lab-confirmed case of coronavirus.
The primary endpoint of this FDA-approved trial is the number of individuals that develop lab-confirmed coronavirus with the progressive; protocol defined symptoms, those that are hospitalized, and those who will die through the study period of the drug. The study is expected to be carried out in partnership with researchers at the Schools of Public health and Medicine at Brown University and Insight Therapeutics at different nursing homes where patients will be given a chance to volunteer in the study.