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Help REWRITE the future for people living with Alpha-1 Antitrypsin Deficiency (AATD)

The REWRITE Clinical Trial is looking to better understand a potential new treatment for AATD called KRRO-110.

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About The Trial

We are looking to better understand a potential new treatment for AATD called KRRO-110.

The purpose of the clinical trial is to test how safe and well tolerated KRRO-110 is, and to gain more information about how the study drug may improve levels of Alpha-1 Antitrypsin (AAT) protein, lung and liver function in patients with AATD.

If you take part, you will complete an evaluation visit to ensure the study is a good match for you. If you are eligible to participate, you will receive the study drug via an infusion and will attend a further five visits to the study centre for the study team to check your health and wellbeing.

Why is this trial important?

Treatment options for people living with AATD are limited and there is no cure. This means there is a focus on finding new and effective treatments that can help to improve the lives of people living with AATD.

Everyone has a protein called Alpha-1 Antitrypsin (AAT), that is important for the lungs and liver to function properly. Patients with AATD have a gene mutation that causes the body to make abnormal copies of AAT that do not function like the normal AAT protein. The abnormal AAT protein can cause people to wheeze, experience shortness of breath, or to have an increased risk of lung infections. These proteins can also collect in the liver and lead to tissue damage and liver diseases.

AATD is not usually fatal but when left untreated, the lung and liver diseases can have a significant impact on quality of life and can also shorten people’s life expectancy.

The investigational drug being evaluated is in a class or category of drugs also known as “antisense oligonucleotides” (ASOs). The study drug specifically corrects the RNA that produces the abnormal AAT protein. The study drug has no effect on DNA. Correction of the abnormal RNA would allow people with AATD to naturally produce healthy copies of AAT and may therefore change how the disease progresses and improve the quality of life for people with AATD.

About KRRO-110

What you should know about the investigational drug

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KRRO-110 is an antisense oligonucleotide (ASO) drug that is designed to correct the abnormal RNA in people with AATD who have the PiZZ gene mutation. This correction does not involve any changes to the DNA and does not permanently alter a person’s genetic material and cannot cause any changes to genes that can be inherited. If KRRO-110 treatment is successful, the correction of abnormal RNA should allow people with AATD to naturally produce healthy copies of the AAT protein.

  • KRRO-110 is investigational drug, which means it is not approved for commercial use by any health authority,
More Details

Would you like to participate?

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

1

Have been diagnosed with AATD

2

Are aged 18 – 70 years

3

Are not currently being treated with augmentation therapy

4

Are not currently participating in another clinical trial

Additional information may be required to confirm your eligibility. Please visit clinicaltrials.gov for full eligibility criteria or contact us at clinicaltrials@korrobio.com

Frequently Asked Questions

If you don't see an answer to your question, you can send us an email at clinicaltrials@korrobio.com with your inquiry.

Clinical trials may also be referred to as clinical studies.

Clinical trials and the people that participate in them are vital to the process of improving medical care. They are designed to help us understand whether potential new treatments are safe and work as intended to help people with a specific disease or condition. Even if participants do not directly benefit from the results of the clinical trial, the information collected can help others and add to scientific knowledge.

The study will last for approximately 12 weeks for those participating in Part A, and will include up to 12 patients with AATD across Australia and New Zealand.

Every study participant will receive a single dose of KRRO-110 during Part A of the clinical trial. The study drug will be made into a solution and given through a vein.

During the follow-up period you will attend five visits to the study centre. You may be asked to come to extra visits if the study team thinks it is needed for safety or other reasons.

During your study visits, the study team will perform physical examinations, vital sign checks, ECGs, blood tests, urine tests, pregnancy tests (if applicable), health & medication checks, and spirometry.

There are some important things that will be required of all participants of the REWRITE Clinical Study

  • Participants must always follow instructions from the study team
  • All study visits must be attended. These visits are important for the health and safety of all participants
  • Participants must not take part in any other clinical research study while taking part in this study
  • The study team must be informed immediately about any side effects or changes in health experienced by study participants, whether or not it is believed to be related to the investigational medication
  • The study team must be consulted before starting any new medication or stopping any medication already being taken
  • Alcohol must not be consumed for at least 72 hours following the dose of the investigational medication
  • Tobacco and/or nicotine (including smoke, vape, chew, patch and gum) must not be used during the study

Locations

The REWRITE Clinical Trial will be conducted at numerous centers in Australia and New Zealand. The latest information is available at clinicaltrials.gov

Address
Level 5/89 Commercial Rd, Melbourne VIC 3004, Australia
Contact Trial Center