부산대학교 도서관

Sovateltide (Tycamzzi™), a selective endothelin-B receptor agonist, has antiapoptotic activity, protects neural mitochondria, and produces neurogenesis. It showed significant safety and efficacy in preclinical and clinical phase I and II studies. A prospective, multicentric, randomized phase III study was conducted in acute cerebral ischemic stroke (ACIS) patients aged 18 through 78 years. Patients with radiologic confirmation of ischemic stroke could be enrolled if presenting up to 24 hours with NIHSS score of greater than 5. Patients with intracranial hemorrhage and those receiving endovascular therapy were excluded. Sovateltide was administered in three doses, each dose of 0.3 μg/kg, as an intravenous bolus at an interval of 3 hours ± 1 hour on day 1, day 3, and day 6 (total dose/day: 0.9 μg/kg). The primary objectives were to determine the neurological outcome based on the mRS score, NIHSS score, and BI scale score from day 1 through day 90. A total of 158 patients with ACIS were enrolled, of which 137 completed a 90-day follow-up. Patients received saline (n=70, 62% male) or sovateltide (n=67, 66% male) at 16.85 ± 0.74 and 17.40 ± 0.67 hours (mean ± SEM) of stroke onset, respectively. The baseline characteristics and SOC in both cohorts were similar. ASPECTS mean value was similar in the control (7.44) and sovateltide (7.61) groups. A significantly greater number of patients in the sovateltide group had an improvement of mRS of ≥2 points (p=0.004) and NIHSS of ≥6 points (p=0.033) vs. baseline at 90 days of treatment. However, an improvement in BI (change of ≥40 points vs. baseline) missed significance (p=0.063). At 90 days, mRS (p=0.007) and NIHSS (p=0.003) were significantly lower, while BI (p=0.011) and EuroQol-EQ-5D (p=0.0055) were significantly higher in the sovateltide compared to the control group. Sovateltide is safe, well-tolerated, and significantly improved neurological outcomes in ACIS patients and may prove to be a novel, effective agent for its treatment.