Topline data from the phase 3 PROTECTOR 1 trial showed that treatment with RTB101 (resTORbio Inc) did not reduce the risk of developing clinically symptomatic respiratory illness in adults aged ≥65 years.
PROTECTOR 1 was a randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of RTB101 10mg once daily vs placebo for 16 weeks during winter cold and flu season in patients aged ≥65 years (N=1024). The primary end point was the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.
Results showed that the odds of experiencing a clinically symptomatic respiratory illness were 0.46 in the RTB101 group vs 0.44 in the placebo group (odds ratio 1.07; P =.65). Based on these findings, the Company has decided to discontinue the development program for this indication.
RTB101 is an oral, selective, potent TORC1 (target of rapamycin complex 1) inhibitor that has been shown in preclinical models to be potentially beneficial in multiple aging-related diseases. “Multiple pre-clinical models have demonstrated that inhibition of TORC1 decreases protein and lipid synthesis, increases lysosomal biogenesis and stimulates the clearance of misfolded protein aggregates, such as toxic synucleins, that cause neuronal toxicity in Parkinson disease,” said Chen Schor, co-founder, president and CEO of resTORbio. The Company is currently evaluating RTB101 in a phase 1b/2a trial for Parkinson disease with expected data to be available mid-2020.
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