resTORbio Presents New Findings on RTB101 During Late-Breaking Session at IDWeek 2019
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
“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.
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.
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.
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.
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 expectations on the timing and anticipated results of our Phase 3 PROTECTOR clinical program of RTB101; 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; our expectations on the potential patient populations that may be addressed by our product candidates; and our ability to replicate results achieved in our clinical trials in any future trials, constitute forward-looking statements identified by words such as, but not limited to, “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” or “could” and similar words or expressions.
Any forward-looking statements in this statement are based on management’s current expectations of future events and 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 Phase 3 PROTECTOR clinical program; the timing and anticipated results of our clinical trials; the risk that the results of our clinical trials will be predictive of future results in connection with future 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 are neither historical facts nor assurances of future performance. Instead, they represent our beliefs, expectations, assumptions and views only as of today and should not be relied upon as representing our beliefs, expectations, assumptions and views as of any subsequent date. resTORbio explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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