MeiraGTx Announces Oral Presentation at the 2024 American Academy of Oral Medicine (AAOM) Annual Conference

LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL.

The details of the oral presentation are below:

Session: Oral Abstract Session I
Presentation ID #196
Title: Results of a Phase 1, Open-label, Dose-escalation Study of Gene Therapy with AAV2-hAQP1 as Treatment for Grade 2 and 3 Radiation-induced Late Xerostomia and Parotid Gland Hypofunction – The AQUAx Study
Presenting Author: Dr. Michael Brennan
Time: 4:20pm ET

Abstract:
Results of a Phase 1, Open-label, Dose-escalation Study of Gene Therapy with AAV2-hAQP1 as Treatment for Grade 2 and 3 Radiation-induced Late Xerostomia and Parotid Gland Hypofunction

Michael Brennan⁵, Michael Passineau¹, Deborah Saunders⁴, Herve Sroussi², Dyani Gaudilliere³, Arthur Fernandez¹, Jun Liu¹, Nathalie Dubois¹, Robert Zeldin^1
1MeiraGTx, New York, NY; ²Brigham and Women's Hospital, Boston, MA; ³Stanford University, Palo Alto, CA; ⁴Health Sciences North, Sudbury, ON, Canada; ⁵Atrium Health, Charlotte, NC; 

Objectives
Grade 2/3 late xerostomia is a chronic, debilitating complication of radiotherapy for head and neck cancers. We assessed the safety and efficacy of AAV2-hAQP1 gene therapy as a treatment for this condition.

Methods
Twenty-four participants with Grade 2/3 xerostomia at least five years after completing radiotherapy (2 years if HPV+) were enrolled in this multi-center, open-label, dose-escalation study. AAV2-hAQP1 was delivered to the parotid gland(s) via cannulation of Stensen’s duct. Twelve participants received AAV2-hAQP1 in one gland and 12 in both glands. Participants were followed for 12 months post-treatment.

Safety parameters included adverse events, physical examinations, laboratory tests, and electrocardiograms. Efficacy assessments included the Xerostomia-specific Questionnaire (XQ), MD Anderson Symptom Inventory-Head and Neck Module (MDASI-HN), Global Rate of Change Questionnaire (GRCQ), and measurement of unstimulated and stimulated whole saliva flow rates (UWSFR, SWSFR).

Results
No treatment-related serious adverse events or dose-limiting toxicities were reported, and all participants completed the study.

Statistically significant improvements were seen in the patient-reported outcome (PRO) instruments by Day 30 and were maintained through Month 12, with greater improvement in the bilateral versus unilateral cohorts.