L606 Inhalation Suspension for Pulmonary Arterial Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhalation treatment called L606 for individuals with pulmonary arterial hypertension (PAH) or pulmonary hypertension with interstitial lung disease (PH-ILD). The trial aims to assess the safety and tolerability of L606 in both the short and long term, comparing it to an existing treatment, Tyvaso. Researchers will also evaluate how L606 affects exercise ability, quality of life, and treatment satisfaction. Individuals diagnosed with PAH or PH-ILD for at least a year and who experience limited physical activity due to their condition might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that L606 is likely to be safe for humans?
Research shows that L606 is undergoing testing to determine its safety for individuals with pulmonary arterial hypertension (PAH) or pulmonary hypertension with interstitial lung disease (PH-ILD). This trial is in a late stage, indicating that earlier studies found the treatment generally safe and well-tolerated. In these late-stage trials, researchers typically test treatments on more participants to confirm safety and effectiveness. Reaching this stage usually suggests that any side effects observed earlier were manageable. However, joining a trial might still involve risks, and the study team will closely monitor any possible side effects.12345
Why do researchers think this study treatment might be promising?
L606 is unique because it is an inhalation suspension specifically designed for Pulmonary Arterial Hypertension (PAH). Unlike standard treatments, which are often oral or injectable medications like endothelin receptor antagonists or phosphodiesterase-5 inhibitors, L606 is inhaled directly into the lungs. This delivery method allows for targeted action, potentially reducing systemic side effects and improving patient comfort and adherence. Researchers are excited about L606 because it offers a new way to manage PAH, potentially leading to quicker relief and better quality of life for patients.
What evidence suggests that L606 might be an effective treatment for pulmonary arterial hypertension?
Research has shown that L606, which participants in this trial will receive, could help treat pulmonary arterial hypertension (PAH). Patients who switched from a similar treatment, nebulized treprostinil, to L606 did not encounter any major safety problems, suggesting that L606 might be a safe alternative. Early studies also indicate that using inhaled treprostinil, like L606, alongside current oral treatments, may improve symptoms. This could enhance exercise ability and quality of life for patients.56789
Who Is on the Research Team?
Jeremy P Feldman, MD
Principal Investigator
Arizona Pulmonary Specialists
Elizabeth Gay, MD
Principal Investigator
Brigham and Women's Hospital
Michael G Risbano, MD
Principal Investigator
UPMC Montefiore
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with Pulmonary Arterial Hypertension (PAH) or PH due to Lung Disease (PH-ILD), who can walk at least 150 meters and have a certain level of heart and lung function. They must not have severe heart disease, uncontrolled blood pressure, recent serious illness, liver dysfunction, or kidney failure requiring dialysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Main Study Period (MSP)
Participants receive L606 to evaluate short-term safety and tolerability
Open-label Extension Period (OEP)
Participants continue L606 dosing to evaluate long-term safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- L606
Find a Clinic Near You
Who Is Running the Clinical Trial?
Liquidia Technologies, Inc.
Lead Sponsor
Pharmosa Biopharm Inc.
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University