Rhu-pGSN for Acute Respiratory Distress Syndrome

Recruiting at 90 trial locations

Overseen By Dmytro Pomishchyk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioAegis Therapeutics Inc.

Disqualifiers: Heart failure, Chronic lung disease, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 1 week

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called rhu-pGSN (recombinant human plasma gelsolin) to determine its effectiveness for people with moderate-to-severe acute respiratory distress syndrome (ARDS), a serious lung condition often caused by infections like pneumonia. Participants will receive either rhu-pGSN with standard care or a placebo, a substance with no active medicine, to compare effects. The trial seeks individuals hospitalized with pneumonia or other infections who developed ARDS within the past 48 hours. It aims to determine if rhu-pGSN can safely improve breathing and health outcomes in these patients. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that rhu-pGSN is likely to be safe for humans?

Research has shown that rhu-pGSN may help reduce inflammation caused by infections in animals, suggesting potential benefits for conditions like Acute Respiratory Distress Syndrome (ARDS). In earlier studies, researchers administered rhu-pGSN alongside standard treatments to compare its safety to a placebo. While more information is needed to fully understand its safety in humans, its progression to a Phase 2 trial indicates that earlier tests deemed it safe enough for further study. This phase focuses on assessing how well people tolerate it and identifying any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Rhu-pGSN is unique because it introduces a novel approach to treating Acute Respiratory Distress Syndrome (ARDS) by utilizing recombinant human plasma gelsolin. Unlike standard treatments, which typically focus on supportive care like mechanical ventilation and medications to manage inflammation, Rhu-pGSN targets the underlying protein imbalances that exacerbate lung injury in ARDS. Researchers are excited about this treatment because it has the potential to restore balance in the body's inflammatory response, possibly leading to faster recovery and improved outcomes for patients with ARDS.

What evidence suggests that rhu-pGSN might be an effective treatment for ARDS?

This trial will compare the effects of rhu-pGSN with a placebo in treating Acute Respiratory Distress Syndrome (ARDS). Research has shown that rhu-pGSN might help reduce lung inflammation, a major issue in ARDS. Studies suggest that adding more gelsolin, a type of protein, into the body could help patients with ARDS recover faster. Rhu-pGSN is designed to address the inflammation that makes breathing difficult in ARDS. Early results indicate that this treatment could improve recovery for people with moderate to severe ARDS caused by infections like pneumonia. While researchers continue to gather information, the potential for rhu-pGSN to help in these serious cases looks promising. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate-to-severe ARDS due to pneumonia or other infections, who are on mechanical ventilation or receiving high-flow oxygen. They must have had acute lung failure within the past 48 hours and show specific signs on chest imaging. Women of childbearing age and men with partners at risk of pregnancy must use reliable contraception.

Inclusion Criteria

I am using or my partner is using effective birth control.

I have severe lung failure due to infection and need help breathing.

I agree to use two approved methods of birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Daily assessments for 7 days

Treatment

Participants receive a single loading dose of rhu-pGSN followed by 5 daily doses or placebo

1 week

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up evaluations on Days 14 and 28

Extended Follow-up

Survival confirmed at Day 60 via telephonic contact or records review

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Rhu-pGSN

Trial Overview

The study tests rhu-pGSN, a potential new treatment for ARDS, against a saline placebo. Both groups receive standard care as well. Participants are randomly assigned to either the test drug or placebo without knowing which one they're getting (double-blind).

How Is the Trial Designed?

Group I: Rhu-pGSN Treatment Experimental Treatment 1 Intervention

Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .

Group II: Normal Saline Placebo Placebo Group 1 Intervention

Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.

Who Is Running the Clinical Trial?

BioAegis Therapeutics Inc.

Lead Sponsor

Trials

5

Recruited

770+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Published Research Related to This Trial

In a mouse model of severe influenza, administering recombinant human plasma gelsolin (rhu-pGSN) starting 3 to 6 days after infection significantly increased survival rates from 39% to 62%.

Rhu-pGSN not only improved survival but also reduced illness severity and lowered pro-inflammatory gene expression, suggesting it could be a beneficial treatment for severe influenza when given after the onset of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed administration of recombinant plasma gelsolin improves survival in a murine model of severe influenza. Yang, Z., Bedugnis, A., Levinson, S., et al.[2020]

In a safety study involving 33 patients with mild community-acquired pneumonia, recombinant human plasma gelsolin (rhu-pGSN) was well tolerated, with only mild adverse events reported and no serious drug-related adverse events in the multidose phase.

The study demonstrated that rhu-pGSN maintained supraphysiologic levels in the bloodstream for over 17 hours, supporting the potential for further investigation in critically ill patients with severe community-acquired pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia. Tannous, A., Levinson, SL., Bolognese, J., et al.[2021]

Citations

1.

bioaegistherapeutics.com

bioaegistherapeutics.com/news/june-17-2025-bioaegis-therapeutics-receives-fda-fast-track-designation-for-lead-product-recombinant-human-gelsolin-for-the-treatment-of-acute-respiratory-distress-syndrome-ards/

June 17, 2025: BioAegis Therapeutics Receives FDA Fast ...

BioAegis' lead product, rhu-pGSN, is currently being studied in a 600-patient global Phase 2 trial for patients with moderate to severe Acute ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05947955

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN ...

3.

clinicaltrials.cedars-sinai.edu

clinicaltrials.cedars-sinai.edu/view/BTI-203

Adjunctive Recombinant Human Plasma Gelsolin With ...

If more gelsolin is injected into the body, it is possible that the lungs will have less inflammation and expedite recovery from ARDS. Eligibility. 1. Infection ...

4.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-safety-and-benefits-of-recombinant-human-plasma-gelsolin-for-patients-with-moderate-to-severe-acute-respiratory-distress-syndrome-ards/

Study on the Safety and Benefits of Recombinant Human ...

This research aims to provide valuable insights into whether rhu-pGSN can improve outcomes for patients suffering from ARDS due to infections like pneumonia.

5.

oxfordglobal.com

oxfordglobal.com/nextgen-biomed/resources/phase-ii-trial-begins-for-recombinant-gelsolin-as-immune-regulator-in-ards-patients

Phase II Trial Begins for Recombinant Gelsolin as Immune ...

BioAegis's recombinant human plasma gelsolin aims to address the inflammatory complications of ARDS.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7508610/

Safety and Pharmacokinetics of Recombinant Human Plasma ...

Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and noninfectious inflammation.