A focused path to proof of concept in chronic angina
ISM-001 to progress through clearly staged plan designed to deliver early, mechanistic insights in patients with chronic angina. Plan fully supported by validated regulatory pathway.
CLINICAL PATH FORWARD
Staged development to deliver early mechanistic insights
Phase 1 – Healthy volunteers
Phase 1b – Chronic angina patients and early proof of mechanism
Phase 2a – Pharmacodynamic proof-of-concept to be achieved using a regulatory approvable endpoint
Hallmarks of chronic angina
Insufficient collateralization causes chronic angina (Rajkumar et al, 2004)
Mismatch between supply and demand under exertion and stress
Recurrent symptoms despite guideline directed medical treatment
At present no disease modifying therapies that stop progression
