PROTECTOR 1 Phase III study, evaluating RTB 101 for symptomatic respiratory illness did not meet its primary endpoint.- resTORbio, Inc.

resTORbio, Inc.announced that top line data from the PROTECTOR 1 Phase III study, evaluating the safety and efficacy of RTB 101 in preventing clinically symptomatic respiratory illness (CSRI) in adults age 65 and older, did not meet its primary endpoint, and that it has stopped the development of RTB 101 in this indication . RTB 101 is an oral, selective, and potent TORC1 inhibitor.

The PROTECTOR 1 Phase III trial was a randomized, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of RTB 101 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 the trial was 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. The PROTECTOR 1 trial included 1024 patients who were randomized 1:1 to receive RTB 101 or placebo administered once daily for 16 weeks. In an analysis of the primary endpoint, the odds of experiencing a CSRI were 0.44 in the placebo cohort and 0.46 in the RTB 101 cohort (odds ratio 1.07, p=0.65). The Company plans to conduct detailed analyses of the PROTECTOR 1 study, including additional data on safety and secondary and exploratory endpoints, which are not available at this time, with the goal of gaining insights that may explain the difference in RTB 101 activity observed in PROTECTOR 1 as compared to prior Phase II studies.

Comment; resTORbio stated that there are extensive preclinical data supporting the potential therapeutic benefit of TORC1 inhibition in multiple aging-related diseases, including Parkinson�s disease, for which the company hasan active Phase 1b/IIa trial of RTB 101 alone or in combination with sirolimus.