US-based clinical-stage biopharmaceutical company Puretech Health subsidiary resTORbio has initiated a Phase IIb study of its mechanistic target of rapamycin complex 1 (mTORC1) programme.
The study will primarily focus on the effectiveness of RTB101 alone or in combination with RAD001 to minimise the occurrence of respiratory tract infections (RTIs) in old age patients at a higher risk of morbidity and mortality due to RTIs.
The 24-week, multicentre, double-blinded, placebo-controlled, dose-range finding study will assess the dose-response relationship of two different doses of RTB101 alone and in combination with RAD001, as measured by the percentage of subjects experiencing one or more RTIs compared to placebo.
The results of this study are expected by the second half of next year.
Previously, low doses of RTB101 alone or in combination with RAD001 have been used to individually target mTORC1.
resTORbio chief executive officer Chen Schor said: “We are pleased to announce the initiation of this study, which marks an important milestone in our effort to develop a new approach to treat aging-related diseases and conditions, including respiratory tract infections.
“Previous clinical studies by our partner Novartis have demonstrated the immune-enhancing potential of mTORC1 inhibitors in elderly populations.
“We look forward to building on this research and further evaluating our mTORC1 programme for multiple indications, including immunosenescence-related conditions.”
Immunosenescence is a condition that represents a decline in the immune function due to age, and is commonly associated with elderly people with low immunity levels, resulting in a decreased ability to fight infections such as RTI.
RTI is reported to be the fourth leading cause of death in the US among people aged 85, as they are most commonly affected with respiratory viruses.
There is currently no effective treatment available for this disease, which is consequently leading to the spread of pneumonia within the community.
Patients older than 65 with underlying risk factors such as asthma, chronic obstructive pulmonary disease (COPD), type 2 diabetes mellitus (T2DM), congestive heart failure (CHF), and smoking are also at a higher risk of RTI-related morbidity and mortality.
resTORbio chief medical officer Joan Mannick said: “Respiratory tract infections are more severe and result in more frequent emergency room visits and hospitalisations in the elderly compared to younger adults.
“By strengthening the immune system with our mTORC1 programme in at-risk elderly populations, we could potentially decrease the burden of infectious diseases in the elderly, which would lead to decreased healthcare resource utilisation globally and significantly improve the quality of life of the elderly.”
The Phase IIb study will be based on two successful Phase IIa studies performed by Novartis, which examined the immune-enhancing potential of these mTORC1 inhibitors in hundreds of elderly patients.