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BOSTON, July 11, 2018 (GLOBE NEWSWIRE) -- resTORbio (Nasdaq:TORC) today announced newly published data from a Phase 2a clinical trial demonstrating that target of rapamycin complex 1 (TORC1) inhibitor treatment improved immune function and decreased incidence of all infections, including respiratory tract infections (RTIs), in people aged 65 years and older. RTIs in particular are a significant health risk for the elderly with life-threatening consequences and few treatment options. Data were published in the July 11, 2018 online edition of the journal Science Translational Medicine.
“Inhibition of TORC1 has extended both lifespan and healthspan in multiple pre-clinical species,” said Joan Mannick, M.D., Co-Founder and Chief Medical Officer of resTORbio. “The results of this Phase 2a trial raise the possibility that TORC1 inhibition also has health benefits in older humans. In the Phase 2a trial, TORC1 inhibitor treatment was associated with a clinically meaningful reduction in the incidence of infections in people aged 65 years and older and an enhancement in the function of the aging immune system as assessed by influenza vaccination response and antiviral gene expression. The results need to be validated in additional clinical trials, but may have broad implications for the treatment of diseases of aging that we are actively investigating with our TORC1 inhibitor program.”
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 the United States. Moreover, the majority of RTIs in the elderly are caused by viruses for which there are currently no approved therapies. resTORbio’s TORC1 inhibitor program has the potential, if successfully developed and approved, to be a new class of immunotherapy that enhances the function of the aging immune system to fight infectious pathogens including viruses, and thereby reduce the incidence of respiratory tract infections.
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 December 31, 2017, as well as discussions of potential risks, uncertainties, and other important factors in resTORbio's subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent resTORbio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. resTORbio explicitly disclaims any obligation to update any forward-looking statements, except as required by law.