Pivotal for the hybrid closed loop system was paused in March following discovery of a “software anomaly”; US launch expected in “first half of 2021”
On Friday morning, Insulet announced that the pivotal trial for Omnipod Horizon has resumed, on the early side of 1Q20 expectations to resume “sometime in June.” The study was paused back in early March, representing a delay of almost exactly three months. On Insulet’s 4Q19 earnings call, just one week before the trial was paused, CEO Shacey Petrovic shared that ~9,000 out of ~21,000 total patient days of data had already been collected; fortunately, the software bug does not affect the validity of the patient data already collected. With ~12,000 patient days left and 240 participants, we’d estimate ~50 days left per participant; however, with the trial moving to a new virtual protocol, the trial and follow-up will likely run a bit longer than the implied two more months. Despite the pause, we heard from Insulet Medical Director Dr. Trang Ly that patients and providers were “incredibly understanding” and didn’t expect the software bug to cause any drop-outs. Especially given the escalation of the COVID-19 pandemic since early March, it’s encouraging that Insulet was able to patch the software bug, get that patch through the FDA, and resume the pivotal trial all in the last three months.
In their press announcement, Insulet maintained plans for US launch of Horizon in the “first half of 2021.” This is in line with Insulet’s recent updates, though about ~six-months behind pre-software-anomaly timing to launch by the end of 2020. On Friday, we’re looking forward to hearing pre-pivotal from Omnipod Horizon at ADA. The timeline for publication or read-out for the full pivotal results is still unclear. As a reminder, the pivotal trial for Horizon began at the end of December and includes patients (n=240) from 6-70 years of age.
--by Albert Cai and Kelly Close