Silver Creek Pharmaceuticals Receives FDA Fast Track Designation for Novel Stroke Therapy scp776

Key Insights

• Silver Creek Pharmaceuticals received FDA Fast Track designation for scp776, an investigational therapy targeting acute ischemic stroke through a novel mechanism that inhibits apoptosis to preserve brain tissue.
• The company's Phase II ARPEGGIO trial evaluating scp776 in acute ischemic stroke patients has completed enrollment, with topline results scheduled for presentation at the World Stroke Congress on October 23, 2025.
• The therapy utilizes Silver Creek's Smart Growth Factor™ platform to selectively deliver insulin-like growth factor 1 (IGF-1) to stressed or injured cells, potentially addressing treatment gaps in stroke and other ischemia-reperfusion injuries.

Silver Creek Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track designation to scp776, its investigational therapy for acute ischemic stroke. The designation recognizes the urgent medical need for novel stroke treatments beyond current reperfusion therapies and the potential of scp776's unique mechanism of action to transform patient care.

"The Fast Track designation highlights both the urgent need for novel stroke therapies and the potential of scp776 to transform care," said Karim Dabbagh, PhD, CEO of Silver Creek. "By interrupting the apoptotic cascade initiated during ischemic injury and reperfusion, scp776 aims to preserve viable brain tissue and improve patient outcomes."

Novel Mechanism Targets Cell Death Pathways

Scp776 represents a multi-specific, targeted biologic designed to promote cell survival in injured tissue by inhibiting apoptosis, identified as a key driver of injury following stroke. The therapy leverages Silver Creek's proprietary Smart Growth Factor™ platform to deliver insulin-like growth factor 1 (IGF-1) selectively to stressed or injured cells, combining molecular engineering with the therapeutic properties of growth factors.

The Smart Growth Factor™ platform utilizes precision-engineered biologics to specifically activate protective pathways in injured tissues while minimizing off-target effects in healthy cells. This targeted approach allows the therapy to reverse apoptosis and protect cells during ischemic injury.

Phase II Trial Completes Enrollment

Silver Creek simultaneously announced that its Phase II ARPEGGIO trial (NCT05585606) evaluating scp776 in patients with acute ischemic stroke has completed enrollment. The study is assessing the safety and efficacy of scp776 in preserving brain tissue and improving neurological outcomes following ischemic stroke.

Topline results from the ARPEGGIO trial will be presented at the World Stroke Congress in Barcelona on October 23, 2025, providing the first clinical data on the therapy's performance in stroke patients.

Broader Therapeutic Applications

The tissue-agnostic mechanism of scp776 extends its potential applications beyond stroke treatment. The therapy's ability to reverse apoptosis and protect cells during ischemic injury positions it for broader clinical applications across conditions driven by apoptotic injury.

Potential applications include ST-elevation myocardial infarction (STEMI), ischemia-reperfusion-related acute kidney injury, and acute lung injury. Scp776 has demonstrated robust efficacy in multiple preclinical models of ischemia-reperfusion injury, supporting its potential across these diverse indications.

Addressing Critical Treatment Gaps

Silver Creek Pharmaceuticals is developing precision biologics through its Smart Growth Factor™ platform to address critical gaps in treatment for stroke, myocardial infarction, and other high-impact medical emergencies. The company's approach harnesses targeted delivery and activation of growth factor signaling to improve outcomes in acute disease states where current treatment options remain limited.