VTRS · Earnings call · 2026Q2T · Full report
Clinical Trial Enrollment Strategy
Viatris Inc · 2026-08-06 · Importance 31 · Surprise 42
Management is allowing the sizable clinical study to continue enrolling rather than stopping early, citing the substantial time, energy, and money already invested. The company expects continued enrollment to generate more events and improve the data available for positioning the drug. Management said allowing the study to run until near data lock should reach the primary endpoint faster than stopping and waiting for events, with ClinicalTrials.gov enrollment ranges providing flexibility for the final patient count.
Key facts
- Selatogrel remains on track to reach full enrollment in SOS-AMI Phase III around year-end and Viatris is maintaining an enrollment rate of approximately 1,200 patients per month
- Selatogrel SOS-AMI protocol originally contemplated enrolling up to 21,000 patients (range 14,000 to 21,000); enrollment may exceed 21,000 and management believes events needed will be obtained by end of year
- Management decision: the clinical study will be allowed to continue enrolling until close to the time the data will be locked so the study will ultimately have more events.
- Management decision: the timing approach for the primary endpoint (by continuing enrollment until close to data lock) allows the company to get to the primary endpoint faster than if they stopped enrollment now and waited for the events to occur.
- Selatogrel shows more than 80% platelet inhibition by 15 minutes, peak inhibition around 6 to 7 hours, and effect wears off within 24 hours
- CABG can be initiated safely about eight hours after a selatogrel injection though waiting is not required if urgent
- For patients not on oral therapy, once the effect of selatogrel has worn off (roughly within 24 hours), an oral P2Y12 can be started if needed
- Management statement: the numbers posted on ClinicalTrials.gov give the company flexibility in how many patients it wants to enroll, and the company changes that number once to give a window rather than changing it multiple times.