RTB101 10 mg once daily was observed to reduce the rate of laboratory-confirmed Respiratory Tract Infections (RTIs) by 78.7% (p=0.001) and the rate of all RTIs (with or without laboratory confirmation) by 66.4% (p=0.003) as compared to placebo among Phase 2b participants 65 years of age and older with asthma
RTB101 10 mg once daily was observed to reduce the incidence of RTIs caused by multiple different viruses including rhinovirus which is the most common viral cause of asthma exacerbations
RTIs are one of the most common risk factors for asthma exacerbations and are caused by multiple viruses most of which lack current treatments
BOSTON, May 20, 2019 (GLOBE NEWSWIRE) -- resTORbio, Inc. (TORC) today announced additional data from the Phase 2b clinical trial of RTB101, an orally administered, small molecule, potent inhibitor of target of rapamycin complex 1 (TORC1). RTB101 was well-tolerated and was observed to reduce the incidence of respiratory tract infections (RTIs) in patients 65 years of age and older at high risk of morbidity and mortality due to RTIs, including those with asthma. These data will be presented today as an oral presentation at the American Thoracic Society (ATS) International Conference (abstract #A2623) in Dallas, Texas.
“These data presented at ATS show that RTB101 may reduce the incidence of respiratory tract infections caused by multiple viruses, most of which lack current treatments. These findings are particularly encouraging in efforts to prevent not only respiratory infections in high-risk elderly asthma patients, but also the consequences of these illnesses – asthma exacerbations,” said William W. Busse, M.D., Professor of Medicine, Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin. “RTB101 represents a potentially important and novel step forward to improve the treatment of patients 65 years of age and older with asthma, and potentially reduce the risk for asthma exacerbations.”
“Viral RTIs are one of the most common causes of asthma exacerbations, and there is a large unmet medical need for antiviral therapies that decrease the incidence of RTIs, particularly in older asthmatics in whom asthma exacerbations are associated with high rates of morbidity and mortality,” said Joan Mannick, M.D., Co-Founder and Chief Medical Officer of resTORbio. “Based on clinical trial findings to date, RTB101 may have the potential to upregulate innate pan-antiviral gene expression and thereby decrease the incidence of RTIs caused by many different viruses in people 65 years of age and older, including asthmatics. We look forward to progressing our PROTECTOR Phase 3 clinical program with RTB101.”
In the U.S., asthmatics 65 years of age and older experience a peak in asthma-related exacerbations and hospitalizations in the winter months when the circulation of respiratory viruses also peaks. Treatment with RTB101 10 mg once daily for 16 weeks during winter cold and flu season was observed to:
Reduce the percentage of patients 65 years of age and older with asthma who developed laboratory-confirmed RTIs by 68.9% as compared to placebo (p=0.0001).
Reduce the percentage of patients 65 years of age and older with asthma who developed any type of RTI (laboratory-confirmed and not laboratory-confirmed) by 58.2% as compared to placebo (p=0.0002).
Reduce the rate of laboratory-confirmed RTIs in patients 65 years of age and older with asthma by 78.7% as compared to placebo (p=0.001).
Reduce the rate of any type of RTI (laboratory-confirmed and not laboratory-confirmed) in patients aged 65 and older with asthma by 66.4% as compared to placebo (p=0.003).
Reduce the incidence of RTIs caused by multiple different viruses in patients 65 years of age and older with asthma.
RTB101 10 mg once daily was observed to be well-tolerated. Adverse events were balanced between the RTB101 10 mg once daily and placebo treatment arm.
About Respiratory Tract Infections (RTIs) in the Elderly
As part of the aging process, the immune system weakens and becomes less effective at detecting and fighting infections such as RTIs. As a result, RTIs are more likely to be of greater severity, prolonged duration, and are more likely 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 RTIs are caused by many different types of viruses, most of which lack effective therapies, there remains a significant unmet medical need for an immunotherapy that enhances the ability of the immune system to fight multiple viruses to reduce illness associated with RTIs in the elderly.
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 enrolling over 900 elderly people, RTB101 was observed to improve immune function by upregulation of antiviral gene expression and to reduce the incidence of RTIs.
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 the immune, cardiovascular and central nervous systems. Learn more about resTORbio, Inc. at www.resTORbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding our future plans to develop RTB101 alone or in combination with rapalogs, such as everolimus or sirolimus, including the therapeutic potential and clinical benefits thereof and the potential patient populations that may be addressed by our product candidates, our ongoing and future clinical trials for RTB101, including the timing of the initiation and anticipated results of these trials, the intended regulatory path for our product candidates and interactions with regulatory authorities, and our ability to replicate results achieved in our clinical trials in any future trials, constitute forward-looking statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar expressions.
Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our planned Phase 3 clinical trials in RTIs and/or development of RTB101, either alone or in combination with a rapalog, such as everolimus or sirolimus; our ability to successfully demonstrate the efficacy and safety of our lead product candidate; the clinical results for our lead product candidate which may not support further development of additional indications; uncertainties related to the results of our clinical trials predictive of future results in connection with future trials, including our Phase 3 clinical trials; the timing and outcome of our planned interactions with regulatory authorities; and obtaining, maintaining and protecting our intellectual property; as well as those risks more fully discussed in the section entitled “Risk Factors” in the Annual Report on Form 10-K filed by resTORbio, Inc. with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our 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.
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