Rhu-pGSN for Acute Respiratory Distress Syndrome

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: BioAegis Therapeutics Inc.

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.

How is the drug Rhu-pGSN unique for treating Acute Respiratory Distress Syndrome?

Rhu-pGSN is unique because it is a recombinant form of a naturally occurring protein that helps modulate the immune response and improve lung defense, which can be beneficial in conditions like Acute Respiratory Distress Syndrome where inflammation is a major issue. Unlike traditional treatments, it enhances the body's ability to clear infections and reduce inflammation, potentially improving outcomes even in severe cases. ^{1 2}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Rhu-pGSN (Anti-inflammatory Protein)

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).

Participant Groups

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+

Tara O'Toole

Biomedical Advanced Research and Development Authority

Chief Executive Officer since 2011

MD, MPH

Matthew Memoli

Biomedical Advanced Research and Development Authority

Chief Medical Officer

MD

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Delayed administration of recombinant plasma gelsolin improves survival in a murine model of severe influenza. [2020]