- Novel mechanism of action reverses and prevents death of injured cells
- Phase II ARPEGGIO trial fully enrolled
- Topline results to be presented at the World Stroke Congress, October 23, 2025
SOUTH SAN FRANCISCO, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Silver Creek Pharmaceuticals, Inc. (Silver Creek), a clinical-stage biotechnology company developing growth factor-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to scp776, its investigational therapy for acute ischemic stroke, a condition with limited treatment options beyond reperfusion.
“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.”
About scp776
Scp776 is a multi-specific, targeted biologic designed to promote cell survival in injured tissue by inhibiting apoptosis—a key driver of injury following stroke. The molecule uses Silver Creek’s Smart Growth Factor™ platform to deliver insulin-like growth factor 1 (IGF-1) selectively to stressed or injured cells, combining molecular engineering with the natural and validated therapeutic power of growth factors.
Phase II ARPEGGIO Trial Reaches Full Enrollment
Silver Creek also announced that its Phase II ARPEGGIO trial (NCT05585606) evaluating scp776 in patients with acute ischemic stroke has completed enrollment. Topline results from the study will be presented at the World Stroke Congress in Barcelona on October 23, 2025.
The ARPEGGIO trial is assessing the safety and efficacy of scp776 in preserving brain tissue and improving neurological outcomes following ischemic stroke.
Broader Mechanistic Potential
Silver Creek’s Smart Growth Factor™ platform leverages precision-engineered biologics to specifically activate protective pathways in injured tissues, minimizing off-target effects in healthy cells. By acting through a mechanism that reverses apoptosis and protects cells during ischemic injury, scp776 has the potential to improve outcomes across a wide range of acute disease states.
Beyond protecting brain tissue after stroke, this tissue-agnostic mechanism has the potential to unlock broader clinical applications across conditions driven by apoptotic injury, such as 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.
About Silver Creek Pharmaceuticals
Silver Creek Pharmaceuticals is pioneering a new class of precision biologics through its proprietary Smart Growth Factor™ platform. By harnessing targeted delivery and activation of growth factor signaling, Silver Creek aims to address critical gaps in treatment for stroke, myocardial infarction, and other high-impact medical emergencies.
Contact:
Jonathan Clem
Public Relations Associate
Rx Medical Dynamics
jclem@rxmedyn.com
(646) 599-8607
