The US Food and Drug Administration (FDA) has issued a proceed forward letter for Pharmazz’s investigational new drug (IND) application to commence a Phase III clinical trial of Sovateltide (PMZ-1620) in acute cerebral ischaemic stroke patients.
After completing a safety review of the protocol, the regulator concluded that Pharmazz can proceed with the proposed clinical trial.
The company intends to include the suggestions of the regulator in the study design and update the protocol for a Special Protocol Assessment as per the FDA’s recommendation.
Pharmazz Board chairman, CEO, and inventor Anil Gulati said: “FDA clearance of our Phase III trial is a significant milestone for Pharmazz and the potential future treatment of acute ischaemic stroke patients.”
The placebo-controlled, randomised, parallel, multi-centric, double-blind Phase III trial has been designed for evaluating sovateltide’s safety and efficacy in 444 acute cerebral ischaemic stroke patients.
In the trial, participants will be randomised into a 1:1 ratio to receive either three sovateltide doses or placebo injections at the same time points, along with standard of care.
The proportion of patients with a good functional outcome with a modified Rankin Score (mRS) of 0-2 on day 90 after randomisation is the trial’s primary endpoint.
The trial’s important secondary endpoints include the proportion of patients with excellent functional outcomes, with an mRS of 0-1 on day 90 post-randomisation, cerebral ischaemic stroke patients with NIHSS scores of ≥ 6, mRS > 2, and BI score ≤ 60 on day six, day 30, and day 90 post-randomisation, and deaths on day 90 post-randomisation.
It will also include any adverse events or serious adverse events that are associated with sovateltide.
The company reported data from the Phase III trial conducted in India in October last year.
The trial showed that a significantly higher number of patients demonstrated an improvement of two or more points on the mRS.