The Challenge in Acute Coronary Syndromes
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Myocardial injury begins within minutes of ischemia
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Standard therapies restore blood flow but do not address early metabolic injury
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Damage continues before and during reperfusion
Time is Tissue
- Acute ischemic events trigger rapid metabolic collapse at the cellular level.
- Once this process begins, irreversible tissue injury can occur within minutes.
- While current standards of care focus on restoring blood flow, they do not address the underlying metabolic failure that develops during the earliest phase of ischemia.
- As a result, critical time is lost between symptom onset and definitive intervention—when tissue remains salvageable but unprotected.
"Time is tissue — IMT-358 is designed to act before irreversible myocardial injury occurs."
IMT-358 was designed to address this unmet window of vulnerability.
Our Solution: IMT-358
IMT-358 is designed to intervene at the earliest and most critical moment of acute ischemia — before irreversible injury occurs.
Unlike current standards of care, which focus on restoring blood flow after damage is already underway, IMT-358 is intended to stabilize cellular metabolism during the initial phase of ischemic stress.
By preserving metabolic integrity during this time-sensitive window, IMT-358 has the potential to reduce downstream tissue injury, limit cardiac instability, and improve outcomes across acute coronary syndromes.
IMT-358 is designed for rapid administration in emergency settings, including pre-hospital and early in-hospital care, aligning with real-world clinical workflows where minutes matter most.
- Early, time-zero intervention
- Metabolic stabilization, not reperfusion
- Designed for emergency use
Learn how IMT-358 fits into emergency care workflows
Program Snapshot
Asset: IMT-358
Indications: Acute coronary syndromes and ischemic emergencies
Therapeutic Approach: Metabolic rescue via glucose-insulin-potassium–based intervention
Administration: Emergency setting (pre-hospital and early in-hospital; IV)
Development Stage: Phase 3 planning
Regulatory Status: FDA Breakthrough Therapy Designation; Special Protocol Assessment (SPA) alignment; BLA pathway anticipated
Clinical Foundation: NIH-funded IMMEDIATE-1 Phase 2 clinical trial, accepted as a pivotal component under FDA Special Protocol Assessment (SPA)
Clinical Proof and Regulatory Momentum
IMT-358 is supported by clinical data generated through the NIH-funded IMMEDIATE-1 trial, a large outcomes-focused study conducted in acute cardiac care settings.
Results from IMMEDIATE-1 demonstrated meaningful signals across safety and efficacy endpoints, informing subsequent regulatory engagement and Phase 3 planning.
Based on these data, the FDA has granted Breakthrough Therapy Designation and aligned with the program on pivotal development under a Special Protocol Assessment.
IMMEDIATE Therapeutics is advancing IMT-358 toward a planned pivotal Phase 3 trial designed to support registration via the BLA pathway.
Where We Are Today
The biological processes underlying acute ischemic injury are shared across multiple clinical settings.
Metabolic collapse, cellular energy failure, and downstream tissue damage follow similar patterns regardless of organ system or cause.
While initial development is focused on acute coronary syndromes, the IMT-358 approach has potential applicability across other time-critical ischemic conditions where early metabolic stabilization may improve outcomes.
- Cardiac arrest and resuscitation
- High-risk cardiovascular and non-cardiovascular surgery
- Trauma and critical care ischemia
- Trauma and critical care ischemia
Additional ischemic conditions may be explored as the platform evolves, guided by biology, clinical need, and regulatory alignment.
