recombinant human plasma gelsolin (rhu-pGSN) / BioAegis Therap - LARVOL DELTA

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: BioAegis Therapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ Sep 2025

Enrollment closed • Trial primary completion date • Inflammation

BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression Sickness (DCS) (The Manila Times) - "The company is currently conducting a Phase 2 study of rhu-pGSN for decompression sickness under a contract awarded by the U.S. Navy’s Office of Naval Research to the University of Maryland School of Medicine (UMSOM)."

Fast track • Immunology • Inflammation

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: BioAegis Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Inflammation

BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (GlobeNewswire) - "BioAegis Therapeutics...announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS)....BioAegis is currently enrolling patients in a 600-patient global Phase 2b trial to evaluate the efficacy and safety of rhu-pGSN in moderate to severe ARDS (NCT05947955)."

Enrollment status • Fast track • Acute Respiratory Distress Syndrome

BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (GlobeNewswire) - "BioAegis Therapeutics...announces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955)...The randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes....Sites are recruiting patients in 13 countries including US, Canada, UK and the EU (Belgium, France, Italy, Germany, Netherlands, Spain, and others). Enrollment is targeted for 600 subjects."

Trial status • Acute Respiratory Distress Syndrome

BioAegis Therapeutics to Highlight Lead Product Gelsolin’s Critical Role in Immune Function at Upcoming Conferences (GlobeNewswire) - "BioAegis Therapeutics...announces that its top executives will attend two upcoming conferences; COO Valerie Ceva will present at MedInvest Biotech & Pharma Investor Conference in New York City on March 27, 2025; CEO Susan Levinson, PhD and Chief Medical Officer Howard Levy, MD PhD MMM, will attend the International Symposium on Intensive Care and Emergency Medicine (ISICEM) conference in Brussels, Belgium from March 18-21, 2025...A poster describing the ongoing Acute Respiratory Distress Syndrome (ARDS) clinical trial of gelsolin will also be presented. Both presentations will take place on March 19....The presentation will also discuss BioAegis’ lead indication, Acute Respiratory Distress Syndrome (ARDS), and its ongoing Phase 2 global study (NCT05947955). The presentation will take place at 4:50PM, Thursday, March 27."

P2 data • Acute Respiratory Distress Syndrome • Respiratory Diseases

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: BioAegis Therapeutics Inc. | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Inflammation • IL1B

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: BioAegis Therapeutics Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Enrollment open • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: BioAegis Therapeutics Inc. | Trial completion date: Mar 2025 ➔ Sep 2025 | Initiation date: Jun 2024 ➔ Jan 2025 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Trial completion date • Trial initiation date • Trial primary completion date • Inflammation • IL1B

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: BioAegis Therapeutics Inc.

New P2 trial • Inflammation • IL1B

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2 | N=520 | Not yet recruiting | Sponsor: BioAegis Therapeutics Inc. | Initiation date: Oct 2023 ➔ Apr 2024

Trial initiation date • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P2 | N=520 | Not yet recruiting | Sponsor: BioAegis Therapeutics Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Plasma Gelsolin in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: BioAegis Therapeutics Inc. | Recruiting ➔ Completed

Trial completion

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY TO EVALUATE PLASMA GELSOLIN IN HEALTHY VOLUNTEERS (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: BioAegis Therapeutics Inc.

New P1 trial

Rhu-pGSN for Severe Covid-19 Pneumonia (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: BioAegis Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP

Adjunctive Recombinant Human Plasma Gelsolin for Severe Coronavirus Disease 2019 Pneumonia. (PubMed, Open Forum Infect Dis) - "When added to dexamethasone and remdesivir, no definitive benefit was demonstrated for rhu-pGSN relative to placebo. Safety signals were not identified after the administration of 3 doses of 12 mg/kg rhu-pGSN over 36 hours. The frequencies of SAEs and intubation were numerically fewer in the rhu-pGSN group compared with placebo."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • GSN

Rhu-pGSN for Severe Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: BioAegis Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP

BioAegis Therapeutics Completes Recruitment for Phase 2 Clinical Trial of Its Inflammation Regulator, Gelsolin, for COVID-19 Treatment (GlobeNewswire) - "...it has completed enrollment for its Phase 2 study of hospitalized patients with severe COVID-19 pneumonia. This study assesses BioAegis’ therapeutic, recombinant human plasma gelsolin (rhu-pGSN)....Low levels of gelsolin are associated with severe illness and organ failure in COVID-19 patients. BioAegis enrolled its last patient in the study which is being conducted at three sites..."

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

NIH and Other Independent Studies Confirm Low Levels of BioAegis’ ‘Inflammation Regulator Protein,’ Gelsolin, Associated with COVID-19 Severity (GlobeNewswire) - "...studies from three independent groups of investigators, including the NIH, have reported that low levels of gelsolin are associated with severity and organ failure in COVID-19 patients...BioAegis is exploring the potential role gelsolin may have in COVID-19 long-haulers...NIH Identifies Gelsolin as a Biomarker to Predict COVID Severity....Organ Failure Scores Associated with Low Gelsolin Levels....Protein Biomarkers Can Aid in Clinical Classification and Potential COVID-19 Therapeutics....They suggest, 'The development of therapies to stabilize the gelsolin levels could hence be of direct therapeutic value for treating COVID-19.'"

Biomarker • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Rhu-pGSN for Severe Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: BioAegis Therapeutics Inc.; Trial completion date: Oct 2020 ➔ May 2021; Trial primary completion date: Oct 2020 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CRP

BioAegis Therapeutics Expands Phase 2 COVID-19 Treatment Clinical Trial in EU for Inflammation Regulator (GlobeNewswire) - "No drug-related safety signals identified by the independent Data and Safety Monitoring Board; The study has recruited more than one third of the expected enrollment and the independent Data Safety Monitoring Board (DSMB) has recently recommended continuation of recruitment....BioAegis is expanding its clinical trial footprint by adding a second Spanish site....BioAegis has already begun recruiting patients at the new site. The company also received approval from the Romania National Agency for Medicines and Medical Devices (NMMD) to extend the trial into Romania. Recruitment for this third site has begun."

DSMB • Enrollment status • Infectious Disease • Novel Coronavirus Disease

Independent Studies Confirm Low Levels of Immune System Protein, Gelsolin, Associated with COVID-19 Severity (GlobeNewswire) - "...low levels of gelsolin are associated with severe illness and organ failure in COVID-19 patients....In a study of 128 respiratory patients...which monitored thousands of diverse biomolecules from patients with and without COVID-19, gelsolin depletion was associated with poor outcomes....A second publication...evaluated 27 potential protein biomarkers in samples collected from a cohort of 31 hospitalized cases....'The development of therapies to stabilize the gelsolin levels could hence be of direct therapeutic value for treating COVID-19.'"

Cytokine storm • Review • Infectious Disease • Novel Coronavirus Disease

Rhu-pGSN for Severe Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: BioAegis Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

BioAegis Therapeutics Initiates Phase 2 Clinical Trial of Its Inflammation Regulator, Gelsolin, for COVID-19 Treatment (GlobeNewswire) - "BioAegis Therapeutics Inc....announced today that it enrolled its first patient in its Phase 2 study of hospitalized patients with severe COVID-19 pneumonia. This study assesses BioAegis’ therapeutic, recombinant human plasma gelsolin (rhu-pGSN), and its unique ability to regulate the overexuberant inflammatory response....BioAegis recruited its first patient and began the study at Hospital Universitari Sant Joan de Reus in Tarragona, Spain."

Cytokine storm • Enrollment status • Infectious Disease • Novel Coronavirus Disease

Rhu-pGSN for Severe Covid-19 Pneumonia (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: BioAegis Therapeutics Inc.; Trial primary completion date: Aug 2020 ➔ Oct 2020

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases