Pharmazz Announces FDA Clearance of an IND Application for Phase 2 Clinical Trial
Pharmazz recently announced US FDA clearance of an Investigational New Drug (IND) application for a Phase 2 clinical trial of centhaquine as an adjuvant to the standard of care in critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS). Centhaquine is the company’s resuscitative agent free of arterial constriction that is commercially available in India and about to start in a Phase 3 trial in the US for the treatment of hypovolemic shock.
“Although the biomedical community has made significant progress fighting SARS-coV2 with multiple vaccines and pharmacological treatments, too many patients still become critically ill and die from COVID-19,” said Anil Gulati, MD, Founder, Chief Executive Officer and Chairman of the Board of Pharmazz. “Centhaquine is a resuscitative agent that is approved for hypovolemic shock in India and about to be evaluated in a Phase 3 trial in the US for this indication. 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. These conditions have similarities to what is observed in COVID-19 patients. In the medical context, resuscitation measures in either the ICU or ER would be similar to hypovolemic shock. Therefore, we believe that evaluating centhaquine in this setting has the potential to show significant clinical benefit.”
The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled study that will enroll 60 patients to assess the efficacy and safety of centhaquine to treat patients with COVID-19 and ARDS. Subjects will receive standard of care and either an intravenous dose of centhaquine, 0.01 mg/kg or a placebo. An additional dose of centhaquine will be administered if oxygenation is required or SBP remains or falls below or equal to 90 mmHg, but not before 24 hours of the previous dose. The primary endpoint of this trial is the improvement of PaO2/FiO2 ratio greater than or equal to 100 mmHg. More information on the clinical trial can be found here: NCT05241067.
Pharmazz, Inc. is a privately held company engaged in developing novel products in critical care medicine. For more information, visit www.pharmazz.com.
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