Cardiac Arrhythmia Suppression Trial

DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Wednesday, September 16, 2020 - 7:00am

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.

Arch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation

Thursday, April 23, 2020 - 9:54pm

The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide.

Key Points: 
  • The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide.
  • A secondary endpoint of the Phase II study is to prevent kidney inflammation and injury, which also contributes to the mortality of COVID19 patients.
  • Patients with severe COVID19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care.
  • A total of 52 healthy, normal volunteers received dosing of Metablok during the Phase I human trial.

Bellerophon Completes Enrollment in Cohort 2 of Ongoing Phase 2/3 Study of INOpulse® for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Thursday, August 1, 2019 - 1:30pm

We have been extremely pleased with the rate of enrollment in Cohort 2, and are thankful for the continued support and enthusiasm from our sites.

Key Points: 
  • We have been extremely pleased with the rate of enrollment in Cohort 2, and are thankful for the continued support and enthusiasm from our sites.
  • We look forward to study completion by year-end 2019, said Fabian Tenenbaum, Chief Executive Officer of Bellerophon.
  • Subjects will complete 16 weeks of blinded treatment on iNO45 vs placebo, and then continue onto open-label treatment.
  • The study is expected to include approximately 300 subjects randomized 1:1 to active or placebo for 16 weeks of blinded treatment.