SynAct Pharma has announced additional results from all treated patients in the Phase 2a clinical trial of AP1189 in Covid-19 infected patients with pulmonary insufficiency.
The study was setup with part 1, where all patients were treated with AP1189, and a part 2, a randomized placebo-controlled study testing AP1189 vs placebo, giving a total of 60 treated patients.
4 days quicker than placebo
In this full dataset, AP1189 treated patients achieved respiratory recovery 4 days quicker than placebo treated patients.
AP1189 treatment appeared to decrease the rate of progression to ventilator use by 57% with 7.1% (3/42) and 16.7% (3/18) of patients requiring a ventilator in the pooled AP1189 and placebo groups, respectively, describes the company. In addition, AP1189 treated patients were on average discharged from the hospital 3.3 days earlier than placebo treated patients.
Data from an exploratory assessment indicated AP1189 may have a positive impact on decreasing the incidence of acute kidney injury (AKI) with 19% of AP1189 patients and 33% of placebo patients demonstrating signs of kidney impairment, a 42% reduction in the rate of AKI incidence, describes the company in a press release.
AP1189 or placebo added onto their concurrent steroid use
It should be noted that in Brazil where the trial was conducted, the standard of care is to give steroids at hospitalization with confirmed Covid-19 infection, so all the patients in this study had AP1189 or placebo added onto their concurrent steroid use. Importantly, AP1189 was well tolerated and safe. The most frequent side-effect was, as previously reported in both healthy volunteers and rheumatoid arthritis patients, nausea.
The RESOVIR (Resolution Therapy for Viral Inflammation Research) collaboration is a scientific and clinical collaboration between Professor Mauro Teixeira, MD, PhD, Universidade Federal de Minas, Belo Horizonte, Brazil, Professor Mauro Perretti, PhD William Harvey Research Institute, Barts and the London School of Medicine, Queen Mary University, London, UK, and SynAct Pharma AB. The aims of the RESOVIR collaboration are to investigate the utility of resolution therapy to resolve the cytokine storm inflammation associated with significant viral infections.
Photo of Jeppe Øvlesen, CEO SynAct Pharma