Restorbio, Inc. (TORC) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Exhibit 99.1

resTORbio Reports Third Quarter 2019 Financial Results and Corporate Update

Top-line data from PROTECTOR 1 study expected by early first quarter of 2020

RTB101 Phase 2b data demonstrating upregulation of innate antiviral immunity presented at IDWeek™ 2019

BOSTON, Massachusetts, November 5, 2019

“We made significant progress advancing our clinical programs during the third quarter of 2019. In July, we completed patient recruitment in our Phase 3 PROTECTOR 1 study, the first of two studies in the pivotal PROTECTOR program of our lead candidate RTB101 for improving immune function and reducing the incidence of clinically symptomatic respiratory illness in older adults. Furthermore, we recently presented encouraging data from our Phase 2b trial of RTB101 at IDWeek 2019 showcasing its ability to upregulate anti-viral immunity in older adults and thereby reduce the incidence of illness associated with respiratory tract infections,” said Chen Schor, Co-Founder, President and CEO of resTORbio. “Additionally, our Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson’s disease is on track to report data next year. We look forward to continuing our efforts to address aging-related diseases.”

Recent Corporate Highlights

Data from PROTECTOR 1 Trial in Clinically Symptomatic Respiratory Illness Expected by Early First Quarter of 2020: Following early completion of enrollment of 1,024 subjects in PROTECTOR 1 trial, the Company expects to report top-line data by early first quarter of 2020. The PROTECTOR 2 trial, resTORbio’s second Phase 3 clinical trial, is planned to begin in the fourth quarter of 2019, with top-line data from the trial expected in mid-2020.

The PROTECTOR Phase 3 program includes two randomized, double-blind, placebo-controlled clinical trials that will evaluate the safety and efficacy of RTB101 10mg given once daily for 16 weeks during winter cold and flu season to subjects 65 years of age and older, excluding current smokers and individuals with chronic obstructive pulmonary disease. The primary endpoint of both trials is the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection, or RTI, based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.

Presented Phase 2b Data on RTB101 in Late Breaking Session at IDWeek 2019: In October 2019, resTORbio presented additional data from its randomized, double-blind, placebo-controlled Phase 2b trial of RTB101 for reducing the incidence of RTIs at the Infectious Disease Society of America’s IDWeek. The data highlighted RTB101’s potential to reduce the incidence of RTIs caused by multiple different viruses via upregulation of pan-antiviral immunity. In addition, in post-hoc analyses, RTB101 10mg 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). Overall, RTB101 was well-tolerated with adverse events balanced between the RTB101 10mg once daily and placebo treatment arms.  

Phase 1b/2a Trial in Parkinson’s Disease (PD) is Progressing with Data Expected in 2020: Preclinical studies suggest that inhibition of TORC1 may be of potential therapeutic benefit in a number of aging-related neurodegenerative diseases such as PD by stimulating the clearance of misfolded protein aggregates that cause neuronal toxicity. resTORbio’s multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a trial is evaluating the safety and tolerability of RTB101 alone or in combination with sirolimus in patients with mild to moderate PD who are already on standard-of-care therapy, including those with and without glucocerebrosidase mutations. The Company expects data from this trial in 2020.