resTORbio Announces an Award from the National Institute on Aging to Fund a Pilot Study of RTB101 as COVID-19 Prophylaxis in Older Adults

Rhea-AI Summary

resTORbio, Inc. (Nasdaq: TORC) announced funding from the National Institute on Aging for a pilot study of RTB101, aimed at evaluating its efficacy in reducing COVID-19 severity among older adults. This double-blind, placebo-controlled study will enroll approximately 60 asymptomatic participants aged 65 and older who have been exposed to COVID-19. The research is positioned to inform future pivotal trials, supported by previous clinical data suggesting RTB101's potential benefits in managing coronavirus infections. The study will be conducted in partnership with Harvard Medical School and the University of Connecticut Health Center.

Positive

• Awarded funding for a pilot study of RTB101 to aid COVID-19 post-exposure prophylaxis.
• Study aims to inform future pivotal trials based on previous positive data.
• Collaboration with reputable institutions like Harvard Medical School enhances credibility.

Negative

• Funding awarded indicates reliance on external support for clinical development.
• Only preliminary data expected from the pilot study, limiting immediate market impact.

BOSTON, July 28, 2020 (GLOBE NEWSWIRE) -- resTORbio resTORbio, Inc. (Nasdaq: TORC) today announced the award from the National Institute on Aging to fund a randomized, double-blind, placebo-controlled pilot study of RTB101, an investigational orally-administered potent small molecule inhibitor of target of rapamycin complex 1 (TORC1), as compared to placebo for COVID-19 post-exposure prophylaxis in older adults. The study is supported by additional data observed in resTORbio’s Phase 2b and Phase 3 clinical trials, which suggest the potential of RTB101 to reduce the severity of laboratory-confirmed coronavirus infections as previously announced.

Funding of a randomized, double-blind, placebo-controlled pilot clinical study of RTB101 prophylaxis to reduce the severity of COVID-19

The new clinical study is a randomized, double-blind, placebo-controlled study to obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age 65 years and older. The purpose of the clinical trial is to inform the design of a potential subsequent pivotal trial in this indication. The trial will enroll adults age 65 years and older who are asymptomatic but have SARS-CoV-2 detected on a surveillance nasopharyngeal swab or have a household member with laboratory-confirmed COVID-19. Approximately 60 subjects are expected to enroll in the study. Subjects will be randomized 1:1 to RTB101 10 mg once daily or matching placebo once daily.

The study will be conducted in collaboration with Investigators at Harvard Medical School/Hebrew Senior Life and University of Connecticut Health Center.

About RTB101
RTB101 is an oral, selective, and potent TORC1 inhibitor product candidate that inhibits the phosphorylation of multiple targets downstream of TORC1. Inhibition of TORC1 has been observed to extend lifespan and healthspan in aging preclinical species and to improve the function of aging organ systems, including the immune system and central nervous system, suggesting potential benefits in several aging-related diseases.

About resTORbio
resTORbio, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to treat aging-related diseases. resTORbio’s lead program selectively inhibits TORC1, an evolutionarily conserved pathway that contributes to the decline in function of aging organ 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, our expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of our clinical trials, including potential impacts on enrollment and initiation; our proposed timing and anticipated results of our clinical trial of RTB101 in patients at risk of laboratory-confirmed COVID-19; 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,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “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: the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, which has been labelled a pandemic by the World Health Organization, the timing and anticipated results of our clinical trials; the risk that the results of our clinical trials may not 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.

Investor Contact
Janhavi Mohite
Stern Investor Relations, Inc.
212-362-1200
janhavi.mohite@sternir.com  

Media Contact
Lauren Arnold
MacDougall
781-235-3060
larnold@macbiocom.com      

FAQ

What is the focus of the recent study funded for resTORbio (TORC)?

The study focuses on the efficacy of RTB101 for COVID-19 post-exposure prophylaxis in older adults.

How many participants will be involved in the resTORbio study?

Approximately 60 participants aged 65 and older are expected to enroll in the study.

Which institutions are collaborating on the resTORbio RTB101 study?

The study will be conducted in collaboration with Harvard Medical School and the University of Connecticut Health Center.

What type of study design is used for the resTORbio COVID-19 research?

The study is a randomized, double-blind, placebo-controlled pilot study.

What does RTB101 aim to achieve based on previous clinical data?

RTB101 aims to reduce the severity of COVID-19 infections among older adults.