MeiraGTx to Present 12-month Data from All Cohorts of the Completed Phase 1 AQUAx Clinical Study and an Update on the Company’s Recently Initiated Phase 2 Study of AAV-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia on Tuesday, June 27,

LONDON and NEW YORK, June 22, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ: MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to present an update on the Company’s AAV-hAQP1 clinical program for the treatment of grade 2/3 radiation-induced xerostomia (RIX) on Tuesday, June 27, 2023, at 8:00 a.m. ET.

The presentation will include:

1) Data from the completed Phase 1 AQUAx clinical study for the 24 patients treated with AAV-hAQP1 in the unilateral and bilateral cohorts:

• Safety and tolerability
  
• 12-month data for PRO assessments of xerostomia symptoms in the unilateral cohorts (n=12)
• 12-month data for PRO assessments of xerostomia symptoms in the bilateral cohorts (n=12)
• Change over time in the objective measure of saliva flow out to 12 months for both bilateral and unilateral cohorts
• Long-term follow up data to 2 or 3 years for the participants who have reached those timepoints
  

2) Summary of biopsy data from a subset of patients in the Phase 1 National Institutes of Health (NIH) study of AAV-hAQP1 in RIX demonstrating parotid transduction and durability out to at least 24-months post-treatment.

3) Overview of the recently initiated randomized, double blind, placebo-controlled Phase 2 study of AAV-hAQP1 for the treatment of RIX, now enrolling patients.

A question-and-answer session will follow the formal presentation.

To register and attend the event, please click here.

A live webcast of the call, as well as a replay, will be available on the Investors page of the Company’s website at www.investors.meiragtx.com/.

About the Phase 1 AQUAx Clinical Trial

The Phase 1 AQUAx clinical trial is an open-label, non-randomized, dose escalation trial designed to evaluate the safety of MeiraGTx’s investigational gene therapy AAV-hAQP1 when administered via Stensen's duct to one or both parotid glands in patients who have been diagnosed with grade 2 or 3 radiation-induced xerostomia and who have remained cancer free for at least five years (or at least two years if HPV+) after receiving radiation treatment for head and neck cancer. Primary endpoint of the trial is safety, with efficacy endpoints including patient reported measures of xerostomia symptoms and the evaluation of the change in parotid gland salivary output after treatment with AAV-hAQP1.