FX06 / F4 Pharma, SIRS Therap - LARVOL DELTA

The fibrin-derived peptide FX06 protects human pulmonary endothelial cells against the COVID-19-triggered cytokine storm. (PubMed, Front Immunol) - "Proteomics and phosphoproteomics analyses demonstrated that FX06 in the presence of the severe cytokine cocktail inactivated RhoGTPase, which was confirmed by western blotting that FX06 attenuated RhoA, a member of RhoGTPase, enhanced by the severe cytokine cocktail and down-regulated the expression of the phosphorylated downstream protein, ROCK1. Overall, FX06 shows promising potential in normalizing ECs and reducing vascular leakage to protect the endothelium against the proinflammatory effect of COVID-19-triggered cytokines."

Journal • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8 • CDH5 • RHOA • SDC1

FX06 to rescue SARS-CoV-2-induced acute respiratory distress syndrome: a randomized clinical trial. (PubMed, Crit Care) - P2 | "In this unique-dosing-regimen study, FX06 did not lower SARS-CoV-2-induced pulmonary vascular leakage. Future investigations will need to evaluate its efficacy at earlier times during the disease or using other regimens. Trial registration NCT04618042. Registered 5 November 2020."

Clinical • Journal • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients - the randomized, EU-wide, placebo-controlled, phase II study design of IXION. (PubMed, Trials) - P2 | "With IXION, the multidisciplinary consortium aims to deliver a new therapy in addition to standard care against SARS-CoV-2 for the clinical management of COVID-19 during mild and moderate stages. Potential limitations might refer to a lack of recruiting and drop-out due to various possible protocol violations. While we controlled for drop-outs in the same size estimation, recruitment problems may be subject to external problems difficult to control for."

Clinical • Journal • P2 data • P2 data • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

study to prevent disease progression in hospitalised non-intubated COVID-19 patients by treatment with FX06 (clinicaltrialsregister.eu) - P2 | N=306 | Ongoing | Sponsor: F4Pharma GmbH i.G.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

FX-COVID: FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=50; Completed; Sponsor: Assistance Publique - Hôpitaux de Paris; Recruiting ➔ Completed

Trial completion • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

FX-COVID: FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases