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A Phase 2b Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections

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Trial Profile

A Phase 2b Randomized Double-blind Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard Care For Moderate-to-Severe ARDS Due To Pneumonia Or Other Infections

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Jun 2025

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At a glance

  • Drugs Gelsolin (Primary)
  • Indications Adult respiratory distress syndrome
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors BioAegis Therapeutics

Most Recent Events

  • 17 Jun 2025 According to a BioAegis Therapeutics media release, company announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Gelsolin for the treatment of moderate-to-severe ARDS.
  • 06 May 2025 According to a BioAegis Therapeutics media release, the company announced the site activation and patient recruitment underway in 13 countries in this trial.
  • 18 Mar 2025 According to a BioAegis Therapeutics media release, comapny will present data from this study at MedInvest Biotech & Pharma Investor Conference in New York City on March 27, 2025 and the International Symposium on Intensive Care and Emergency Medicine (ISICEM) conference in Brussels, Belgium from March 18-21, 2025.

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