Serpin Pharma completes Phase 1b/2a SPIRIT Clinical Trial

Serpin Pharma, a clinical-stage biotech company developing first in class drugs to treat human diseases caused by inflammation, reported data from its Phase 1b/2a clinical trial. The results, published in the Journal of Cardiovascular Pharmacology, report the effects of a single subcutaneous administration of SERPIN drug (SP16), a synthetic, selective LRP1 agonist, in ten patients with ST-segment elevation Myocardial Infarction (STEMI). The clinical trial appraised the safety and tolerability of SP16, as well as explored its effects on the acute inflammatory response, infarct size, and cardiac function.

The single-center, single-arm, open-label study was led by Dr. Antonio Abbate and Dr. Benjamin Van Tassell at Virginia Commonwealth University in Richmond, Virginia. Patients with STEMI were enrolled within twelve hours of symptom onset and six hours of percutaneous coronary intervention (PCI). Serial clinical biomarkers and echocardiography data were collected up to 12 months. All ten patients with STEMI received subcutaneous administration of SP16 without any treatment-related serious adverse events. A trend toward reduction in the inflammatory response and infarct size was noted. According to Dr. Abbate and Dr. Van Tassell, “SP16’s modulation of the inflammatory response is a promising therapeutic strategy in AMI.”

A recently published editorial in the Journal of Cardiovascular Pharmacology echoes the enthusiasm for SP16 as a potential paradigm shift in acute coronary syndromes.

“We are very encouraged by these data results, which provide additional validation of SP16 therapeutic potential through its unique mechanism of action,” remarked Dr. Cohava Gelber, CEO and Executive Chairperson of Serpin Pharma. “This data clearly demonstrates the safety and tolerability of SP16 and its promise in treating inflammatory diseases. Our mission is to deliver this treatment to patients and this data brings us an important step closer.”

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