| Program | Indication | Discovery | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | Anticipated Milestones |
|---|---|---|---|---|---|---|---|
TORC1 Program: RTB101 and RTB101 + Everolimus |
Respiratory Tract Infections |
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Phase 2b top-line data in 2H 2018 |
Other Infections* |
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Initiation of at least one Phase 2 trial in 2018** |
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Heart Failure with Preserved Ejection Fraction |
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Autophagy-Related Diseases |
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* other infections include those that the elderly are at increased risk of contracting, such as urinary tract infections
** For heart failure with preserved ejection fraction, autophagy-related diseases and certain other infections, the Company may be required to file an investigational new drug application, or IND, prior to initiating Phase 2 clinical trials.
The Company expects to have the ability to initiate these Phase 2 clinical trials without the need to conduct prior Phase 1 trials.
The Company also has a follow-on TORC1 inhibitor program at discovery stage
About Respiratory Tract Infections in the Elderly
Mortality among people age 75 and over is highest each year during winter cold and flu season. In the United States, RTIs are the fifth leading cause of death in people age 85 and over and the seventh leading cause of death in people age 65 and over. In addition, RTIs contribute to high healthcare burden and costs. 7% of people aged 85 years and over go to the emergency room with RTIs each year. Further, two-thirds of people aged 85 and over who go to the emergency room for infection-related reasons are hospitalized, and once hospitalized, one-third of people aged 85 and over are admitted to a nursing home. The majority of RTIs are caused by viruses for which there are no approved therapies. Despite this, antibiotics are often prescribed indiscriminately to treat RTIs, which may cause side effects related to antibiotic use and contribute to the growing global problem of antibiotic resistance.
About RTB101
RTB101 is an orally administered, small molecule, potent TORC1 inhibitor. RTB101 partially inhibits TORC1 by binding to the active site of mTOR on the TORC1 complex, a mechanism known as catalytic inhibition. Everolimus also is an orally administered small molecule. Everolimus partially inhibits TORC1 by changing the shape of TORC1, a mechanism known as allosteric inhibition. The combination of RTB101 and everolimus may yield complete and selective TORC1 inhibition.