PMZ-1620 Enters Phase III Trial in Patients with Cerebral Ischemic Stroke

Pharmazz has received permission to initiate a prospective, multicentric, randomized, double-blind, parallel, phase III clinical study to assess efficacy of PMZ-1620 along with standard treatment in patients of acute ischemic stroke in India. PMZ-1620 (IRL-1620; INN sovateltide) is a highly selective endothelin-B receptor agonist that has been found to be safe in human phase I and II trials.

A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study (CTRI/2017/11/010654) was conducted in forty patients with cerebral ischemic stroke, of which 36 completed 90-day follow-up. All patients received standard treatment and were randomly assigned to either control (saline; n=18) or PMZ-1620 cohort (n=18) and received saline or PMZ-1620 within 24 hours of onset of stroke.

A rapid improvement in clinical outcome was observed in patients treated with PMZ-1620. In saline 12.50% while in PMZ-1620 cohort 87.50% (P=0.0201) patients showed an improvement of ≥6 in National Institutes of Health Stroke Scale (NIHSS) from baseline (enrollment time) at day 6 of treatment. Modified Rankin scale (mRS) on day 6 when compared to that observed on day 1 showed significance value of P=0.0859 in saline cohort, while in sovateltide cohort it was P<0.0001. Barthel index (BI) on day 6 when compared to day 1 was similar (P=0.3948) in saline cohort, whereas it significantly (P<0.0001) improved in sovateltide cohort.

At 90 days of treatment 36.00% and 64.00% patients in control and PMZ-1620 cohorts, respectively showed an improvement of ≥40 in BI (P=0.0112).  An improvement of ≥2 in Modified Rankin scale (mRS) was observed in 39.13% and 60.87% patients in saline and PMZ-1620 cohorts, respectively at 90 day of treatment (P=0.0519). Number of patients with 100% recovery achieving NIHSS score of 0 (P=0.04791), mRS of 0 (P=0.1193) and BI of 100 (P=0.02795) were more in PMZ-1620 cohort compared to saline.

PMZ-1620 treatment did not have any effect on hemodynamic, biochemical or hematological parameters. No incidence of drug related adverse event was reported.

PMZ-1620 (INN sovateltide) has the potential to be a first-in-class neuronal progenitor cell therapeutics with anti-apoptotic activity that improves cerebral blood flow and neurological outcome in cerebral ischemic stroke patients.

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