Clinical Development

Improving Immune Function – Reducing the Incidence of Illness Associated with RTIs

In May 2019, resTORbio initiated a global Phase 3 PROTECTOR program to evaluate the safety and efficacy of RTB101 for decreasing the percent of patients 65 years of age and older with clinically symptomatic respiratory illness. The PROTECTOR program includes two randomized, double-blinded, placebo-controlled clinical trials to evaluate RTB101 10 mg once daily for 16 weeks during winter cold and flu season. The trial excludes current smokers and chronic obstructive pulmonary disease, or COPD, patients. The primary endpoint is the reduction in the percentage of patients with clinically symptomatic respiratory illness with or without laboratory-confirmation of a pathogen. PROTECTOR 1, the first Phase 3 clinical trial, initiated in the southern hemisphere, is expected to enroll approximately 1,000 patients. PROTECTOR 2, the second Phase 3 clinical trial, is planned to begin in the northern hemisphere in the fourth quarter of 2019 and is expected to enroll approximately 1,600 patients. Based on current enrollment expectations for the Phase 3 program, top-line data are expected from both PROTECTOR Phase 3 trials in mid-2020.

Neurodegenerative Diseases – Parkinson’s Disease

In April 2019, resTORbio initiated a randomized, double-blind, placebo-controlled Phase 1b/2a trial for Parkinson’s Disease, or PD. The trial is expected to enroll 45 patients with mild to moderate PD who are already on standard-of-care therapy, including those with and without glucocerebrosidase, or GBA, gene mutation. The trial is evaluating the safety and tolerability of RTB101 alone or in combination with sirolimus in PD over four weeks. Patients are expected to be enrolled into five cohorts and dosed once-weekly with RTB101 300mg alone or in combination with three dose levels of sirolimus (2 mg, 4 mg and 6 mg). The planned primary endpoint of the trial is safety and tolerability, and secondary endpoints will include exposure in blood, plasma and cerebrospinal fluid, or CSF. Exploratory endpoints include biomarkers in plasma and CSF, and various clinical assessments. Data from this trial are expected in 2020.

Keep checking back with us for updates on ongoing and new clinical studies.