What is Soveteltide used for?

Sovateltide for Acute Cerebral Ischemic Stroke

Sovateltide (Tycamzzi™) is an endothelin-B receptor agonist approved for the treatment of acute cerebral ischemic stroke within 24 hours of stroke onset. 1

Mechanism of Action and Indications

• Sovateltide is a highly selective endothelin-B receptor agonist that increases cerebral blood flow, has anti-apoptotic activity, and promotes neural repair following cerebral ischemic stroke 2
• It is specifically indicated for patients with acute cerebral ischemic stroke presenting within 24 hours of symptom onset 1
• The drug works by initiating regenerative responses through promoting differentiation of neuronal progenitors while maintaining stem cells in equilibrium following cerebral ischemia 3

Dosing and Administration

• Sovateltide is administered intravenously at a dose of 0.3 μg/kg 4
• The standard regimen consists of three doses administered at 3±1 hour intervals on days 1,3, and 6 of treatment 2
• It is given as an intravenous bolus over 1 minute 4
• The drug is administered as an adjunct to standard of care for stroke management 4

Clinical Efficacy

• In Phase III clinical trials, sovateltide demonstrated significant improvements in neurological outcomes compared to placebo:
  • The proportion of patients with modified Rankin Scale (mRS) scores of 0-2 at day 90 was 22.67% higher in the sovateltide group (odds ratio 2.75) 2
  • Patients receiving sovateltide were more likely to achieve National Institutes of Health Stroke Scale (NIHSS) scores of 0-5 at day 90 (odds ratio 2.67) 2
  • An improvement of ≥2 points on the mRS was observed in 72.5% of sovateltide patients versus 51.28% in the control group 2
• Earlier Phase II studies showed improvements in Barthel Index scores, with 64% of sovateltide patients achieving ≥40 point improvement versus 36% in the placebo group 4

Safety Profile

• Sovateltide has demonstrated a favorable safety profile in clinical trials:
  • No drug-related adverse events were reported in Phase II studies 4
  • The drug does not significantly affect hemodynamic, biochemical, or hematological parameters 4
  • The incidence of intracranial hemorrhage was similar between sovateltide (8.75%) and control groups (8.97%) in Phase III trials 2
• Safety and tolerability were confirmed in healthy human volunteers prior to stroke patient trials 4

Patient Selection Considerations

• Inclusion criteria from clinical trials suggest optimal candidates include:
  • Adult patients aged 18-78 years 2
  • Radiologically confirmed ischemic stroke 4
  • NIHSS score ≥6 at presentation 2
  • Treatment initiation within 24 hours of symptom onset 2
• Patients with recurrent stroke, those receiving endovascular therapy, or those with intracranial hemorrhage were excluded from pivotal trials 2

Future Applications

• Sovateltide is currently under investigation for additional neurological conditions:
  • Alzheimer's disease 5
  • Acute spinal cord injury 5
  • Neonatal hypoxic-ischemic encephalopathy 5
• A multinational RESPECT-ETB trial is planned for seeking US regulatory approval 2

Clinical Pearls

• Sovateltide represents a novel therapeutic approach as it targets neural repair mechanisms rather than just focusing on reperfusion 5
• The drug is administered as an adjunct to standard stroke care, not as a replacement 4
• The treatment window of 24 hours is longer than that for traditional thrombolytic therapy, potentially benefiting patients who present later after symptom onset 2
• Quality of life measures (EQ-5D and SSQoL) showed improvements at 90 days post-treatment 4