GEn-1124 for ARDS

Recruiting at 10 trial locations

Overseen By Ritu Lal, PhD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GEn1E Lifesciences

Must not be taking: Immunosuppressants, Anti-rejection meds

Disqualifiers: Active malignancy, Liver failure, Heart failure, Respiratory disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, GEn-1124, to determine its safety and tolerability for people with Acute Respiratory Distress Syndrome (ARDS), a serious lung condition that makes breathing very difficult. Participants will receive the treatment through an IV twice daily for five days, starting soon after their ARDS diagnosis. Different groups will receive either a low or high dose of GEn-1124 or a placebo. This trial suits those recently diagnosed with ARDS who can start treatment quickly.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have used an investigational drug recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GEn-1124 has been tested for safety in people with acute respiratory distress syndrome (ARDS). Early results suggest it is generally well-tolerated. In past studies, participants taking GEn-1124 did not experience any major side effects. As a Phase 2 study, GEn-1124 has already passed initial safety tests in humans. This phase aims to determine the right dose and monitor for any side effects. However, as with any new treatment, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ARDS?

Unlike current treatments for Acute Respiratory Distress Syndrome (ARDS), which often involve supportive care like mechanical ventilation and corticosteroids, GEn-1124 offers a novel approach. Researchers are excited about GEn-1124 because it uses a distinct mechanism of action that targets specific pathways involved in inflammation, potentially reducing lung damage more effectively. Additionally, GEn-1124 is administered intravenously twice daily, which might offer more precise control of dosing compared to some conventional therapies. This new treatment could lead to quicker improvements and better outcomes for patients with ARDS.

What evidence suggests that this trial's treatments could be effective for ARDS?

Research shows that GEn-1124 could be promising for treating acute respiratory distress syndrome (ARDS). In earlier studies, GEn-1124 lowered death rates in animals with ARDS caused by bacteria and the flu. These results suggest that GEn-1124 might help reduce deaths in humans with ARDS. Currently, no FDA-approved treatments exist for ARDS, making GEn-1124 an important option to explore. In this trial, participants will receive either a low or high dose of GEn-1124, or a placebo, all administered through an IV, allowing it to enter the bloodstream quickly. ^{1 2 3 4 6}

Who Is on the Research Team?

Ritu Lal, PhD, MS

Principal Investigator

GEn1E Lifesciences

Are You a Good Fit for This Trial?

Adults aged 18-80 with a recent diagnosis of ARDS can join this trial. They must be hospitalized, able to consent, and use birth control. Excluded are burn victims with extensive injuries, those with unstable heart disease or severe lung conditions, people in prison or mental health facilities, anyone who's had organ transplants or certain infections like TB and hepatitis.

Inclusion Criteria

Written informed consent

Dosing as early as possible after first meeting ARDS 2023 Global definition

Acceptable method of birth control

Exclusion Criteria

I have active Hepatitis B, untreated Hepatitis C, or a positive HIV test.

I regularly use medication that weakens my immune system.

My liver is not working well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive GEn-1124 or placebo via IV infusion BID for 5 days

5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

What Are the Treatments Tested in This Trial?

Interventions

• GEn-1124
• Placebo

Trial Overview The study tests GEn-1124 against a placebo in patients with ARDS. Participants receive an IV infusion within 48 hours of diagnosis followed by twice-daily doses for five days to assess safety and tolerability.

How Is the Trial Designed?

Group I: Part 2: GEn-1124 Experimental Treatment 1 Intervention

Depending on the analysis of part 1, subjects in part 2 will receive GEn-1124 BID intravenous for 5 days.

Group II: Part 1 Cohort 2: GEn-1124 Experimental Treatment 1 Intervention

Subjects in cohort 2 will receive high dose GEn-1124 BID intravenous for 5 days.

Group III: Part 1 Cohort 1: GEn-1124 Experimental Treatment 1 Intervention

Subjects in cohort 1 will receive low dose GEn-1124 BID intravenous 5 days.

Group IV: Placebo Placebo Group 1 Intervention

Subjects randomized to placebo will receive a placebo in a matching dosing regimen (Placebo BID intravenous for 5 days).

Who Is Running the Clinical Trial?

GEn1E Lifesciences

Lead Sponsor

Trials

2

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05795465?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22GEn1E%20Lifesciences%22))&rank=2

A Study of GEn-1124 in Subjects With Acute Respiratory ... GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as ...

2. mountsinai.org mountsinai.org/clinical-trials/study-of-gen-1124-in-subjects-with-acute-respiratory-distress-syndrome-ards

A Study of GEn-1124 in Subjects with Acute Respiratory ... GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS.

3. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A5636

American Journal of Respiratory and Critical Care Medicine GEn-1124 reduced mortality in both bacterial and influenza models of acute respiratory distress syndrome (ARDS). The purpose was to study the ...

4. clinconnect.io clinconnect.io/trials/NCT05795465

A Study of GEn-1124 in Subjects with Acute Respiratory GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as ...

5. gen1e.com gen1e.com/ards

ARDS ARDS is a devastating lung condition with no FDA approved treatment, 40%+ mortality rate, and a cost of $100K per patient.

6. gen1e.com gen1e.com/phase-2-study

Phase 2 Study GEn-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as ...