News
Feb 10, 2023
Silver Creek Presents ARPEGGIO, a Phase 2 Clinical Trial Evaluating Scp776 — a First-in-Class Cell Rescue Drug — for the Treatment of Acute Ischemic Stroke
The design of the ARPEGGIO study was presented at the American Heart Association’s International Stroke Conference 2023 (PDF)
SAN FRANCISCO, February 10th, 2023 — Silver Creek, a biotechnology company headquartered in San Francisco, presented the ARPEGGIO study at the International Stroke Conference in Dallas, Texas.
Scp776 is a first-in-class targeted insulin-like growth factor 1 (IGF-1) fusion protein designed to mitigate cellular damage following acute injury. Scp776 was well tolerated in healthy men and women in two Phase 1 studies.
“Scp776 was designed and engineered to allow clinicians to harness the pro-survival signaling of IGF-1 to the treatment of tissue injuries,” said Lakhmir Chawla, M.D., chief medical officer of Silver Creek. “The ARPEGGIO trial is the first opportunity for scp776 to translate a robust preclinical data package to human patients that have suffered an acute injury.”
ARPEGGIO is a Phase 2 randomized, placebo-controlled, double-blind, multicenter clinical trial that will evaluate the safety and cerebroprotective capacity of scp776 in acute ischemic stroke patients undergoing endovascular thrombectomy. The trial design has two parts: Sequential dose escalation (Part A) followed by dose expansion (Part B). The trial is expected to enroll up to 100 individuals across approximately 20 stroke centers in the US (ClinicalTrials.gov Identifier: NCT05585606).
The company presented details of the trial design and the data supporting the continued clinical advancement of scp776 in an Ongoing Clinical Trial poster at the American Heart Association’s International Stroke Conference (ISC) 2023 (poster # CTP8). The presentation also disclosed efficacy results from a recent preclinical study in a model of acute ischemic stroke.
About Scp776
Scp776 is Silver Creek’s lead investigational therapy leveraging the company’s Smart Growth FactorTM platform technology. Scp776 is a first-in-class, targeted fusion protein that harnesses the cell survival function of insulin-like growth factor 1 (IGF-1). It is designed to inhibit apoptosis in damaged tissues, including hypoxia in brain tissue.
About Silver Creek Pharmaceuticals
Silver Creek is a clinical-stage biotechnology company headquartered in San Francisco, CA. Silver Creek’s Smart Growth Factor™ platform technology enables the rapid development of targeted therapeutics with broad scope and applicability across indications. For more information about Silver Creek, please visit us at silvercreekpharma.com.
Forward Looking Statements
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: statements about the design of the Phase 2 ARPEGGIO study of scp776; the potential clinical effects of scp776; the potential benefits, safety and efficacy of scp776; the clinical development program for scp776; our research and development program for the treatment safety and cerebroprotective capacity for scp776 in acute ischemic stroke patients undergoing endovascular thrombectomy; the potential of our commercial business and pipeline, including scp776; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of scp776; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including scp776; the occurrence of adverse safety events; the risks of unexpected hurdles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement. These statements are based on our current beliefs and expectations and speak only as of the date of this news release.
We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.