PureTech Health’s independent affiliate, resTORbio reported positive topline results from its Phase 2b clinical study with TORC1 inhibitor, that enrolled 652 elderly patients at increased risk of death related with respiratory tract infections (RTIs).
According to the resTORbio’s press release, the trial met it’s primary goal as it showed reduction in the percentage of patients with one or more laboratory-confirmed RTIs during 16 weeks compared to placebo.
Joe Bolen, Chief Scientific Officer of PureTech Health said that resTORbio’s proprietary TORC1 inhibitor, RTB101, has significantly reduced the percentage of elderly individuals with respiratory tract infections (RTIs) across two Phase 2 clinical studies at the 10 mg once daily dose, and that PureTech Health believes RTB101 may be a promising new treatment for elderly individuals who are at high risk of RTI-associated morbidity and mortality.
Joan Mannick, Co-Founder and Chief Medical Officer of resTORbio, said that this Phase 2b has successfully defined a dose, RTB101 10 mg once daily, to be evaluated in future pivotal studies. He explained how that dose led to a statistically significant decrease in the incidence of laboratory-confirmed RTIs and was well-tolerated in the high-risk elderly patients enrolled in the Phase 2b study. “We have also identified patient populations that were particularly high responders. We believe the findings of this trial provide us with a clear path forward for pursuing a pivotal program for RTB101 to reduce the incidence of RTIs in high-risk elderly patients. We look forward to working closely with the U.S. Food and Drug Administration (FDA) and other regulatory agencies on this program.”
Professor Sebastian Johnston, Professor of Respiratory Medicine and Allergy at the National Heart and Lung Institute, Imperial College London said that the majority of RTIs requiring hospitalizations in the very elderly and the majority of asthma exacerbations are caused by viruses for which there are currently no approved therapies. He said that the magnitude of reduction in the incidence of laboratory-confirmed RTIs observed with RTB101 suggests that, if successfully developed and approved, RTB101 may be a new promising treatment for the very elderly and elderly patients with asthma who are at high risk of morbidity and mortality associated with RTIs.
Co-Founder, President and CEO of resTORbio, Chen Schor pointed out that the primary endpoint of this Phase 2b study, the percentage of patients with laboratory-confirmed RTIs, was chosen based on feedback from the FDA. He said that resTORbio will discuss the results at the end of Phase 2 meeting with the agency. “RTIs are the fourth leading cause of hospitalization in patients 65 years and older, and the second leading cause of hospitalization in patients 85 years and older in the U.S. We are committed to helping the millions of elderly patients at high risk of morbidity and mortality due to RTIs,” he said.