IMPAHCT:
Looking for a new way to treat Pulmonary Arterial Hypertension (PAH)

The IMPAHCT Study is investigating a potential new medication (an “investigational medication”) for PAH. The study aims to find out which dose, or strength, of the investigational medicine is safe and tolerable, and works best in people with PAH.

Researching new treatment options

Current drugs for PAH help relieve symptoms like fatigue and shortness of breath but fail to treat the underlying cause of the disease. Aerovate Therapeutics is aiming to change the way PAH is treated. They are currently researching a targeted investigational therapy that is designed to relieve the symptoms of PAH and address an underlying cause of the disease.

What is PAH?

PAH is a rare and serious disease that affects more women than men (about 65–80% of patients), with the average age of those affected being around 50. In PAH, blood vessels in your lungs have thickened and narrowed due to an increased build-up of cells, resulting in high blood pressure in the right side of your heart.

This causes the right side of your heart to work harder to move blood into your lungs through those narrowed blood vessels. Over time, your heart can weaken from this extra work and could possibly fail.

Aerovate aims to target PAH differently

Aerovate has developed a dry powder formulation of imatinib that can be inhaled. Imatinib is a medicine that is designed to limit cell growth, stopping cells from building up and blocking blood vessels in your lungs. In doing so, imatinib may help your heart pump blood to the lungs. With the help of an inhaler, this investigational medicine goes directly to damaged blood vessels in the lungs.

We’re aiming to take the wind out of PAH.
And you’re invited.

What is A

Clinical research study?

A clinical research study helps answer important questions about a new investigational medicine, such as:

Does it work?
What amount, or dose, may work best?
How safe is it?
Are there side effects?

All medications must be tested in clinical research studies before they can be approved to be prescribed to patients.

About the Aerovate IMPAHCT Study

This clinical research study is looking at a potential new medication (an “investigational medication”) for PAH. The investigational medication contains a substance that has been approved to treat other medical conditions. It is being formulated as an inhaled medication for patients with PAH. This inhaled medication is only available to participants of the clinical research trial. The study aims to find out which dose (strength) of the investigational medication is safe, tolerable, and works best in people with PAH.

Why is the IMPAHCT Study important?

Most of the currently available therapies for PAH help to relieve the symptoms but do not significantly reverse the damage caused by PAH to the blood vessels in the lungs. Therefore, there is a critical need to research potential new treatments for PAH. The aim of the investigational medicine is to target one of the key causes of PAH using an approach different from the currently available treatments.

What will the IMPAHCT Study involve?

If you are eligible and take part, you will be in the IMPAHCT Study for up to about 7 months (32 weeks).

You will have at least 8 study visits, including 3 remote visits (by phone).
You will receive either the investigational medication or a placebo. A placebo looks the same as the investigational medication but contains no active medication.
You will take the study drug (the investigational medication or placebo) using a dry powder inhaler twice every day.
You may continue taking most, if not all, of your current PAH medications during the study.

The IMPAHCT Trial is being conducted at select medical centers around the world.

The study has 3 periods

Screening period
(up to 28 days)

You will visit the study center to see if the study is suitable for you and to decide whether you want to take part.

Study treatment period
(about 24 weeks)

You will take the study drug using an inhaler twice every day, once each in the morning and evening.
You will have 7 visits for study assessments. These visits will include both study center visits and phone calls.

Long-term extension study or safety follow-up period

Upon completion of the study treatment period, you may have an option to continue into a long-term extension (LTE) study. In the LTE study, all participants will receive the investigational medication until it is commercially available.
Alternatively, if you do not take part in the LTE study, you will receive 1 final phone call for study assessments, about 28 days after the study treatment period is complete.

Who can take part?

You or someone you care for may be able to take part if you/they:

Are 18–75 years of age
Have been diagnosed with PAH
Have been receiving stable doses of at least 2 PAH medications for at least the past 90 days

Potential study participants will need to be assessed at a medical center participating in the IMPAHCT trial to confirm whether or not they meet all of the criteria for participation in the trial.

What else do I need to consider?

If your eligibility to participate in the trial is confirmed by an IMPAHCT study site, there are additional points to consider.

The study team will explain the possible benefits and risks of the study.
You do not have to take part in the study if you do not want to.
If you choose to take part in the study, you can stop participating at any time.
You will not be paid to take part in this study, but you may be reimbursed for reasonable travel costs during your participation.
The study drug and all study-related tests and assessments will be provided at no cost to you.
A team of doctors and nurses will monitor your health carefully during the study.