RTB101 respiratory tract infection prevention in older adults
phase 3drug program · high · Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Prevent or reduce clinically symptomatic respiratory illness and laboratory-confirmed respiratory tract infections in adults aged 65 years or older by improving antiviral immune function.
Randomized, double-blind, placebo-controlled phase 2b and phase 3 trials of oral RTB101, including dose-finding arms and an RTB101 plus everolimus/RAD001 arm, measuring respiratory illness, laboratory-confirmed RTIs, and IFN-induced antiviral gene expression.
Phase 3 trial enrolled 1024 older adults and did not meet the primary endpoint for reducing clinically symptomatic respiratory illness; phase 2b showed a statistically significant reduction in laboratory-confirmed RTIs for RTB101 10 mg once daily in a prespecified pooled analysis.
RTB101 was reported safe and well tolerated and upregulated IFN-induced antiviral genes. Phase 2b showed fewer laboratory-confirmed RTIs with RTB101 10 mg once daily versus pooled placebo, while phase 3 did not reduce clinically symptomatic respiratory illness versus placebo.
RTB101 COVID-19 prophylaxis and severity reduction in older adults
phase 2drug program · high · Tue Oct 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate whether RTB101 can prevent COVID-19 after exposure or decrease severity of laboratory-confirmed COVID-19 in adults aged 65 years or older, including nursing home residents.
Phase 2 placebo-controlled studies of RTB101 prophylaxis in older adults, including post-exposure prophylaxis and nursing-home outbreak settings.
Two Phase 2 clinical trial records were published in 2020 for COVID-19 post-exposure prophylaxis and severity reduction in nursing home residents.
mTOR inhibitors for enhancing immune response
exploratoryresearch program · medium · Thu May 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Use mTOR inhibitors to enhance immune response, including antiviral or infection-related immune function in older adults.
Patent-backed research program covering mTOR inhibitor dosing and use for enhancing immune response; related clinical work used RTB101 and combinations with mTOR-pathway agents.
Patent publication AU2014348657A1 lists mTOR inhibitors for enhancing immune response, with priority date 2013-11-13 and publication date 2016-05-19.
RTB101 Parkinson's disease program
phase 2drug program · medium
Develop RTB101 alone and in combination with sirolimus for Parkinson's disease, targeting biology of aging and alpha-synuclein-related disease biology.
Investigational oral selective TORC1 inhibitor program, including RTB101 alone and RTB101 in combination with sirolimus in a Phase 1b/2a Parkinson's disease program.
Company site states RTB101 is being developed alone and in combination with sirolimus, including a Phase 1b/2a program for Parkinson's disease.