Analysis indicates RTB101 upregulates innate antiviral immunity to prevent clinically symptomatic respiratory illnesses caused by multiple viruses in older adults
BOSTON, Oct. 02, 2019 (GLOBE NEWSWIRE) -- resTORbio, Inc., (Nasdaq: TORC), a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases, will present new data today about RTB101, the company’s investigational oral, selective, and potent TORC1 inhibitor, during the Infectious Disease Society of America (IDSA) IDWeek™ 2019 conference. RTB101 inhibits the TORC1 pathway and has been observed to upregulate innate antiviral immunity and reduce the incidence of illnesses associated with respiratory tract infections (RTIs) in older adults.
A randomized, double-blind, placebo-controlled phase 2b clinical trial in 652 older adults was conducted to evaluate the efficacy of different doses and dosing schedules of RTB101 for the reduction of laboratory-confirmed RTIs when administered for 16 weeks during winter cold and flu season. In pre-specified analyses, RTB101 10 mg once daily was observed to upregulate interferon-stimulated antiviral gene expression in whole blood (p = 0.00001 vs. placebo) and to decrease the incidence of RTIs caused by multiple different viruses. These findings suggest that RTB101 may reduce the incidence of respiratory tract infections by enhancing pan-antiviral immunity. In post-hoc analyses, RTB101 10 mg once daily was observed to reduce the time to alleviation of moderate to severe RTI symptoms by an average of five days as compared to placebo (p=0.025) and to reduce the rate of all-cause hospitalization by 56% (p=0.047). RTB101 was well-tolerated; with adverse events balanced between the RTB101 10mg once daily and placebo treatment arms. RTB101 is currently under evaluation in the Phase 3 PROTECTOR clinical program, with topline data expected from the PROTECTOR 1 study by early first quarter of 2020.
“Respiratory tract infections cause substantial morbidity and mortality in people age 65 and older due to the decline in immune defense that occurs with age. A major challenge in effectively managing these illnesses is the wide range of causative viruses, very few of which have approved methods for prevention or treatment, so there is a need for new approaches that can improve the ability of the aging immune system to defend against these viral infections,” said Michael Wechsler, M.D., M.M.Sc., Director, NJH Cohen Family Asthma Institute, Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, in Denver. “The data observed in this study provide preliminary evidence that if successfully developed and approved, RTB101 may be able to enhance pan-antiviral innate immune defenses in older adults, and thereby reduce the incidence of illnesses associated with RTIs.”
“By targeting the immune system rather than the virus, we believe RTB101 has the potential to decrease the incidence of respiratory illness associated with many different viruses without the risk of developing viral resistance,” said Dr. Joan Mannick, Co-Founder and Chief Medical Officer of resTORbio. “These findings suggest that targeting the biology of aging with RTB101 may address previously intractable aging-related conditions.”
About Respiratory Tract Infections in Older Adults
As part of the aging process, the immune system weakens and becomes less effective at detecting and fighting pathogens that cause infections such as RTIs. As a result, RTIs are more likely to be of greater severity, prolonged duration, and to be associated with medical complications in people 65 years of age and older compared to younger adults. In the U.S., RTIs are the fourth leading cause of hospitalization and seventh leading cause of death in people 65 years of age and older. Given that the majority of RTIs are caused by many different types of viruses, most of which lack effective therapies, there remains a significant unmet medical need for a therapy that enhances the ability of the immune system to fight multiple viruses to reduce illness associated with RTIs in older adults.
About RTB101
RTB101 is an oral, selective, and potent TORC1 inhibitor product candidate. TORC1 inhibition has been shown to be of therapeutic benefit in multiple aging-related conditions in preclinical species including immunosenescence (aging-related decline in immune function). In two Phase 2 clinical trials that enrolled over 900 older adults, RTB101 was observed to upregulate antiviral immunity and to reduce the incidence of RTIs.
About resTORbio
resTORbio, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases. resTORbio’s lead program selectively inhibits TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including immune, neurologic and cardiac function. Learn more about resTORbio, Inc. at www.resTORbio.com.
