resTORbio Advances to Part 2 of a Phase 2b Clinical Study of RTB101 Immunotherapy
ResTORbio Advances To Part 2 Of A Phase 2b Clinical Study Of RTB101 Immunotherapy Following Unanimous Recommendation Of Independent Data Monitoring Committee Overseeing The Study
BOSTON, Massachusetts, November 20, 2017 – resTORbio, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of aging-related diseases, today announced that an independent Data Monitoring Committee (DMC) has unanimously recommended advancing an ongoing Phase 2b clinical study to Part 2 of the study. The Phase 2b clinical study is a dose-range finding study of RTB101, an orally-administered TORC1 inhibitor, alone or in combination with everolimus as a first-in-class immunotherapy designed to enhance the ability of the aging immune system to fight infections. The Phase 2b clinical study is designed to assess the safety, tolerability and efficacy of 16 weeks of treatment with RTB101 alone or in combination with everolimus as compared to placebo in reducing the percentage of elderly individuals with respiratory tract infections (RTIs).
The independent DMC reviewed the safety and efficacy data from 179 elderly individuals from Part 1 of the randomized, multicenter, double-blinded, placebo-controlled Phase 2b clinical study and recommended moving forward to Part 2 of the study that is expected to enroll 424 elderly individuals to three active arms and a placebo arm. The clinical study is at least 80% powered to demonstrate a statistically significant difference in the percentage of individuals with one or more RTIs, assuming an effect size of 40% reduction.
“The unanimous recommendation by the independent DMC to continue the study following review of safety and efficacy from Part 1 of the study is a significant milestone for our program. RTIs are the fifth leading cause of death in people age 85 and over and the seventh leading cause of death in people age 65 and over, and result in high healthcare burdens for the elderly and high healthcare costs for healthcare systems,” said Dr. Joan Mannick, Chief Medical Officer of resTORbio.
Mechanistic target of rapamycin (mTOR) is a protein serine/threonine kinase that regulates multiple cell functions, including cell growth and metabolism, via two complexes: TORC1 and TORC2. TORC1 inhibition has been found to have many beneficial effects on aging-related diseases and conditions, while TORC2 inhibition has been associated with adverse events including hyperglycemia and hypercholesterolemia. The TORC1 inhibitor program being developed by resTORbio may therefore have therapeutic potential to ameliorate multiple aging-related diseases with a favorable safety profile.
resTORbio, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the target of rapamycin complex 1 (TORC1) pathway to treat aging-related diseases and conditions with an initial focus on conditions caused by immunosenescence, the decline in immune function that occurs during aging. resTORbio’s lead product candidate, RTB101, is in a Phase 2b clinical trial to evaluate its potential in reducing the incidence of respiratory tract infections (RTI) in elderly subjects at increased risk of RTI-related morbidity and mortality. resTORbio’s lead program is supported by two Phase 2a clinical studiesfrom which promising safety and efficacy signals were observed in almost 500 hundred elderly subjects. resTORbio is pursuing a pragmatic clinical development plan to address areas of key unmet medical need in the aging population. For more information, please visit www.restorbio.com. resTORbio is an affiliate of PureTech Health.
Allison Mead Talbot
Director, Communications and Investor Relations
+1 617 651 3156