PMZ-1620, an Endothelin-B Agonist, enters Phase III Trial in Patients with Cerebral Ischemic Stroke

WILLOWBROOK, Ill., July 18, 2019 /PRNewswire/ -- Pharmazz, Inc., today announced that it 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. The company also announced publication of a key article titled "Anti-apoptotic activity of ETB receptor agonist, IRL-1620, protects neural cells in rats with cerebral ischemia" in Scientific Reports. Full-text access to paper is at the following link: https://rdcu.be/bKOYh.

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.

About Pharmazz, Inc. 

Pharmazz, Inc. is a privately-held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.  

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.

Contact
Pharmazz, Inc. 
Shruti Gulati
630-780-6087
shruti.gulati@pharmazz.com 

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SOURCE Pharmazz, Inc.