The US Food and Drug Administration (FDA) has granted clearance to Pharmazz’s Investigational New Drug (IND) application to commence a Phase II clinical trial of centhaquine to treat critically ill Covid-19 patients with acute respiratory distress syndrome (ARDS).
The treatment is intended to be used as an adjuvant to the standard of care (SoC) in such individuals.
A resuscitative therapy that is free of arterial constriction, centhaquine is available in the Indian market.
It demonstrated enhanced systemic hemodynamics and clinical improvement for ARDS in individuals suffering hypovolemic shock.
The multicentre, randomised, double-blind, placebo-controlled trial will analyse the safety and efficacy of centhaquine in 60 subjects.
These participants will be categorised to receive either an intravenous 0.01mg/kg dose of centhaquine or a placebo, along with SoC.
The company noted that another dose of centhaquine will be given to subjects if oxygenation is needed or SBP continues or drops below or equal to 90 mmHg.
An additional dose of the agent will not be administered within 24 hours of the initial dose in this scenario.
The improvement of PaO₂/FiO₂ ratio greater than or equal to 100mmHg will be the trial’s primary endpoint.
Pharmazz founder, CEO and board chairman Anil Gulati said: “Centhaquine acts by improving cardiac output and blood circulation without arterial constriction.
“In addition to hemodynamic stability, centhaquine significantly improved acute respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS) in clinical trials conducted on hypovolemic shock patients.”
Centhaquine is set to enter a Phase III trial to treat hypovolemic shock in the US.