Study Information

What is the study drug?

The study drug delivers a gene designed to make a specific protein that allows water to flow into the parotid ducts and then into the mouth to moisten it. The study drug is investigational and is not yet approved for general use by regulatory authorities.

How long will the study last?

Study participation will last for about one year.

At the end of the AQUAx2 study, participants will be invited to enroll in a separate long-term follow-up study.  During the long-term follow-up study the participants’ health will be monitored for up to four or five more years.

How many visits will I have to make during the trial?

There are 13 study visits. These are comprised of three screening visits to determine eligibility, one dosing visit to receive the gene therapy, and nine follow up visits to monitor health and safety.

How many participants are in the study?

This study will include about 120 participants at about 30 clinics in the US, Canada, and UK.

Who can participate in the study?

Study participants must meet certain criteria* to qualify for the study:

1. 18 years old or older
2. It must be at least 3 years since your final radiation treatment
3. You must be suffering from moderate or severe xerostomia
4. You must be free from recurrence of your cancer and never have had another form of cancer
5. You must not have a diagnosis of Sjogren’s syndrome, myasthenia gravis or acute angle closure glaucoma
6. You cannot be infected with HIV
7. You cannot have kidney failure
8. You cannot be an active smoker and may not have used any tobacco product (including vaping) in the past 3 years
9. You cannot have uncontrolled diabetes (Hemoglobin A1c >7%)

*Other criteria apply