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Lung Transplant

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20,000

People living with a lung transplant
in the US

60%

5-year survival rate of transplant patients

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ARINA·1 has been shown to downregulate the inflammation associated with the development and progression of bronchiolitis obliterans syndrome (BOS) in a lung transplant, which is the leading cause of death in people with a lung transplant. The therapy has the potential to meet an immense unmet need to improve pulmonary function, quality of life, and overall clinical outcomes in people with early BOS following lung transplant. 

 

Lung transplant recipients have the lowest long-term success rate of all solid organ transplants. There is an urgent need in individuals with a lung transplant for therapies that promote the clearance of pathogens from the airways and decrease pathological inflammation, while not leaving a patient susceptible to infection. Approximately 2,500 lung transplants are performed annually and approximately 20,000 people live with a lung transplant in the US. Despite slight improvements in survival rates, the 5-year survival rate remains at 60%, the lowest survival rate of all solid organ transplants. There are currently no FDA-approved therapies for treating BOS progression in a lung transplant.

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Do you qualify?

Main Entry Criteria

  1. Bilateral lung transplant more Decrease in FEV1 of 10-24% from baseline within the last 12 months

  2. Currently using a 3-agent immunosuppression regimen

  3. Currently using azithromycin

  4. No new therapies in the last 28 days.

Current Status

Phase 3 Clinical Trial

Prevention of BOS Progression

Primary Endpoint:

Improvement of 7% in FEV1 compared to the control arm.


Secondary Endpoints:

Quality of life, time to augmented immunosuppression, use of augmented immunosuppression, FVC, FEF25-75%


Duration:

48 weeks (Primary Endpoint at 24 weeks)

Trial Number:

NCT05654922 - Click here to see if your clinic is participating!

Patient Enrollment Status

Enrolling Now

Est. NDA Filling Date

2024

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Lung Allograft Dysfunction
Acute

Acute Cellular Rejection (ACR)

Infection after Lung Transplant (INFX)

FEV1 – Forced exhaled vol. in 1 sec

FVC – Forced vital capacity

Reversible

Azithromycin Reversible Allograft Dysfunction (ARAD)

Chronic

Chronic Lung Allograft Dysfunction CLAD

Target Patient Population

Bronchial Obliterans Syndrome (BOS)
Declines in FEV1

Restrictive Allograft Syndrome (RAS)

Declines in FVC

Table Key

Understanding Bronchiolitis Obliterans Syndrome (BOS)

What is it? How is it different from RAS or other declines in lung function?
  • BOS is a lung problem that can occur after lung transplantation. It is the most common form of chronic lung transplant rejection, or chronic lung allograft dysfunction (CLAD).

  • BOS is considered an ‘obstructive’ lung disease. This means that your FEV1 decreases are greater than decreases in FVC.

  • BOS is defined by inflammation and mucus plugging in the lungs that leads to airway scarring. This scarring causes the airways to narrow and to be ‘obstructed’.

  • Restrictive airways syndrome (RAS) is another type of CLAD that can occur post-lung transplant.

  • RAS is considered a ‘restrictive’ lung disease. It is characterized by a decrease in FVC prior to a decrease in FEV1.

  • RAS in characterized by inflammation and fibrosis of the lungs that leads to the lungs not being able to move as effectively with each breath, or ‘restricting’ the airways.  

 
Why use a nebulized therapy in BOS?
  • Lung-specific

  • Fewer off-target side effects

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Other Target Indications for ARINA·1

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