resTORbio Announces Science Translational Medicine Publication of Phase 2a Data Showing Improvement in Immune Function and Decreased Infection Rates in People Aged 65 Years and Older
- resTORbio’s TORC1 inhibitors enhanced the function of the aging immune system and were associated with a statistically significant decrease in the incidence of all infections, including respiratory tract infections, in older people
- Respiratory tract infections are the 4th leading cause of hospitalization and the 7th leading cause of death in people 65 years of age and older
“Inhibition of TORC1 has extended both lifespan and healthspan in multiple pre-clinical species,” said
The data for this publication were gathered in a randomized, double-blinded, placebo-controlled Phase 2a study of 264 elderly volunteers at least 65 years of age without unstable medical conditions. Subjects were treated for 6 weeks with study drug and after a 2-week drug-free interval, were given a seasonal influenza vaccine. The incidence of infections was assessed for one year after initiation of study drug treatment. In the RTB101 monotherapy and RTB101+everolimus combination treatment arms, statistically significant and clinically meaningful reductions in the annual rate of infections of 33% (p=0.008) and 38% (p=0.001), respectively, compared to placebo, were observed. In addition, both RTB101 monotherapy and the RTB101+everolimus combination therapy were observed to reduce the incidence of RTIs at one year by 42% (p=0.006) and 36% (p=0.01), respectively. The combination of RTB101+everolimus was also observed to significantly enhance the response to influenza vaccination and upregulated the expression of critical antiviral genes that play a key role in enabling the immune system to protect the elderly from respiratory tract infections.
RTIs are the fourth leading cause of hospitalizations and the seventh leading cause of death in people aged 65 years and older in
Based on the results of the Phase 2a study, resTORbio is conducting a Phase 2b clinical trial to further investigate the potential benefits of RTB101 alone and in combination with everolimus in aging-related diseases. In the ongoing Phase 2b study, doses of RTB101 alone and in combination with everolimus are being evaluated as an immunotherapy to decrease the incidence of RTIs in older people at increased risk of morbidity and mortality from RTIs (defined as age 85 and older and age 65 and older with comorbidities). Dosing has been completed in the Phase 2b study and 16-week topline data are expected to be reported in the third quarter of 2018.
RTB101 is an oral, selective and potent inhibitor of target of rapamycin complex 1 (TORC1). RTB101 inhibits the phosphorylation of multiple targets downstream of TORC1. The combination of RTB101 with everolimus is synergistic and results in broader TORC1 inhibition. Inhibition of TORC1 has been observed to extend lifespan and healthspan in aging pre-clinical species and enhances immune, cardiac and neurologic function, suggesting potential benefits in several diseases of age.
resTORbio, Inc. is a clinical-stage biopharmaceutical company targeting TORC1 and other biological pathways that regulate aging to develop innovative medicines with the potential to extend healthy lifespan. resTORbio’s lead program is targeting the selective inhibition of TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiovascular and central nervous systems.
Various statements in this release concerning resTORbio’s future expectations, plans and prospects, including without limitation, statements regarding our plans to develop and commercialize RTB101 alone or in combination with everolimus, including the therapeutic potential and clinical benefits thereof, our ongoing Phase 2b clinical trial for RTB101 alone or in combination with everolimus, including the timing of anticipated results constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, the risk of delay of any planned clinical trials and/or development of resTORbio’s lead product candidate, RTB101, either alone or in combination with everolimus, resTORbio's ability to successfully demonstrate the efficacy and safety of its lead product candidate, the clinical results for its lead product candidate which may not support further development of additional indications, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical and clinical trials, obtaining, maintaining and protecting intellectual property, resTORbio’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, resTORbio’s ability to manage operating expenses, resTORbio’s ability to obtain additional funding to support its business activities, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in resTORbio’s annual report on Form 10-K for the fiscal year ended