MeiraGTx To Present Clinical Program Update for AAV-hAQP1 Treatment of Radiation-Induced Xerostomia

Webcast and conference call to take place on December 17, 2020 at 8:00 a.m. ET

LONDON and NEW YORK, Dec. 16, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company will host a webcast and conference call to provide an update on the Company’s AAV-hAQP1 clinical program for the treatment of radiation-induced xerostomia.

The webcast will include discussion of the first cohort of patients (n=3) treated in the Company’s Phase 1 AQUAx clinical trial. Of the three patients treated in Cohort 1, one patient has reached the 12-month assessment and two have passed the six-month assessment. In these patients, the investigational gene therapy AAV-hAQP1 has been well tolerated with no dose limiting toxicity and no serious adverse events reported. Encouraging responses have been seen in both patient-reported measures of xerostomia symptoms and in salivary output in the patients treated in Cohort 1, with complete resolution of symptoms in the patient who has reached the 12-month timepoint. AQUAx trial investigator Dr. Michael Brennan, DDS, from Atrium Health’s Carolinas Center for Oral Health, will speak about his experience treating patients with radiation-induced xerostomia, and discuss the encouraging results he has observed in the patients he has treated to date in the AQUAx trial.  

Details of the webcast are listed below:

Title: MeiraGTx Xerostomia Clinical Program Update
Presenters:

• Alexandria Forbes, Ph.D., President and CEO of MeiraGTx
• Michael Brennan, DDS, MHS, FDS RCSEd, Director of the Sjögren’s Syndrome and Salivary Disorders Center, Atrium Health’s Carolinas Center for Oral Health
• Robert K. Zeldin, M.D., Chief Medical Officer of MeiraGTx

Date: Thursday, December 17, 2020
Time: 8:00 a.m. ET

A live webcast will be available on the Investors page of the Company’s website at https://investors.meiragtx.com/events-presentations. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1 (866) 796-1272 (U.S.) or 1 (409) 937-8924 (International) to listen to the live conference call. The conference ID number for the live call is 8582943. A replay of the webcast and accompanying presentation materials will be available on the Company’s website for 30 days following the live conference call.

About Xerostomia
Xerostomia is a chronic and debilitating disorder of the salivary glands in which saliva production is impaired. Xerostomia has a number of causes, including radiation therapy for head and neck cancer and certain autoimmune diseases. In the U.S., there are more than 170,000 patients with chronic grade 2/3 radiation-induced xerostomia. In these patients, reduced salivary output results in a lack of lubrication and a loss of the antimicrobial and antifungal properties of saliva with consequent morbidities and significant negative impact on patient quality of life. Current options for the management of xerostomia are few and are of limited benefit so there is a high unmet medical need for a safe and effective treatment.

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 a single parotid gland 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 the evaluation of the change in parotid gland salivary output after treatment with AAV-hAQP1 and patient reported measures of xerostomia symptoms.

About MeiraGTx
MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visit www.meiragtx.com.