Top line results from the phase 3 trial of sovateltide in patients with acute cerebral ischemic stroke are expected by mid-2020.
Anil Gulati, MD, PhD
The first patient has been dosed in the phase 3 clinical trial assessing sovateltide (PMZ-1620; Pharmazz) for the treatment of acute cerebral ischemic stroke, according to an announcement by Pharmazz.1
The randomized, parallel-assigned phase 3 trial (NCT04047563) is expected to enroll 110 patients who will be randomly assigned to receive 3 doses of sovateltide via intravenous bolus over a 6-day period plus best available standard of care, or 3 doses of equal volume normal saline plus best available standard of care over the same period. Sovateltide will be administered as an intravenous bolus over 1 minute every 3 hours + 1 hour on days 1, 3, and 6 (total dose/day: 0.9 ug/kg body weight).
The first patient was dosed on November 10, 2019, and since then, 7 more patients have been enrolled. Investigators are still actively recruiting patients for the study and expect to have top-line results by the middle of 2020.
Adults aged 18 and 76 with a stroke condition that is ischemic in origin and who have prior radiology of the stroke confirmed by a computed tomography (CT) scan or magnetic resonance imaging (MRI) can be included. Additionally, patients must receive the first dose of sovateltide less than 24 hours from time of stroke onset. Exclusion criteria includes patients receiving endovascular therapy, patients who are classified as comatose, or those who show evidence of intracranial hemorrhage.
The primary outcome measures include change in National Institute of Health Stroke Scale (NIHSS) and change in modified Rankin Scale (mRS) score, among others.
Pharmazz reported results from the phase 2 study (NCT0406484) of sovateltide at the 2019 American Heart Association Scientific Sessions, which took place November 16-18, 2019.2 Results showed that treatment with sovateltide was associated with significant improvement on the NIHSS, mRS, and Barthel Index (BI) compared to standard treatment in patients with acute ischemic stroke.
In the sovateltide group, 60.87% of the patients saw an improvement of >2 on the mRS compared with 39.13% of patients in the placebo cohort at day 90 posttreatment. Improvements of >40 on the BI (P = .0112) were seen in 36% and 64% of patients in the control and sovateltide group, respectively. Notably, over the 90-day study, the sovateltide group saw a larger number of patients achieve a NIHSS score of 0 (P = .04791), mRS of 0 (P = .1193) and BI of 100 (P = .02795) compared with the placebo group.
1. Dosing of first patient in phase 3 pivotal study of sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke [news release]. Willowbrook, Ill: Pharmazz. November 23, 2019. biospace.com/article/releases/dosing-of-first-patient-in-phase-3-pivotal-study-of-sovateltide-pmz-1620-a-first-in-class-investigational-product-for-acute-cerebral-ischemic-stroke. Accessed date: November 26, 2019.
2. Gulati A, Agrawal NR, Vibha D, et al. Efficacy of sovateltide (PMZ-1620), a first-in-class neuronal progenitor cell therapeutics, in patients with cerebral ischemic stroke. Presented at: AHA Scientific Sessions 2019. November 16-18, 2019. Abstract 14683.