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MeiraGTx to Provide a Xerostomia Clinical Program Update and Host a Virtual Research and Development Day on Gene Regulation

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MeiraGTx Holdings plc (NASDAQ: MGTX) announced a conference call on December 7, 2021, to discuss updates on its Phase 1 AQUAx clinical trial targeting radiation-induced xerostomia. Additionally, a virtual R&D Day will occur on December 15, 2021, focusing on their gene regulation platforms. The AQUAx trial evaluates AAV-hAQP1's safety and its efficacy in improving salivary output in patients post-radiation therapy. The company is pioneering riboswitch gene regulation technology, aiming to address unmet medical needs across multiple areas, including ocular and neurodegenerative diseases.

Positive
  • MeiraGTx's Phase 1 AQUAx clinical trial will provide key insights into the safety and efficacy of its AAV-hAQP1 gene therapy for xerostomia.
  • The company is advancing its innovative riboswitch gene regulation technology, which has broad applications for genetic medicine.
Negative
  • None.

LONDON and NEW YORK, Nov. 29, 2021 (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 provide an update on the Company’s AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia (RIX) on Tuesday, December 7, 2021, at 8:00 a.m. ET.

MeiraGTx will also host a virtual R&D Day via webcast and conference call that will be held on Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET to focus on the Company’s gene regulation platforms.

The Phase 1 AQUAx conference call will include a clinical program update for product candidate AAV-hAQP1, a potential treatment for RIX, from MeiraGTx’s senior management as well as lead investigator Michael Brennan, DDS, Chairman of the Department of Oral Medicine and Director of the Sjögren’s Syndrome and Salivary Disorders Center at Atrium Health Carolinas Medical Center. A question and answer session will follow the formal presentation.

MeiraGTx’s R&D Day webcast will feature presentations from Alexandria Forbes, Ph.D., President and Chief Executive Officer, and other members of the Company’s R&D team. The event will provide a detailed overview of the Company’s riboswitch gene regulation platform and an audience question and answer session.

MeiraGTx’s xerostomia clinical program update details are as follows:

  • Tuesday, December 7, 2021, at 8:00 a.m. ET.
  • To register and attend the event, please click here
  • For those who are unable to listen live, a replay of the call will be available by clicking here

MeiraGTx’s virtual R&D Day details are as follows:

  • Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET
  • A registration link and a link to the R&D Day will be provided closer to the event

A live webcast of both events, 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 the evaluation of the change in parotid gland salivary output after treatment with AAV-hAQP1 and patient reported measures of xerostomia symptoms.

About MeiraGTx’s Riboswitch Gene Regulation Platform
MeiraGTx is pioneering a transformative platform technology that allows precise activation of gene expression with proprietary oral small molecule inducers. The inducible gene expression platform is based on synthetic riboswitches rationally designed for mammalian cells, a short RNA hairpin sequence that includes a small molecule binding aptamer that specifically and reversibly binds to the corresponding small molecule inducer. MeiraGTx’s riboswitch gene regulation system provides an unprecedented platform for spatial and temporal control of gene therapy with broad implications for the applicability of genetic medicines for treating a wide range of potential disorders not limited to inherited diseases.

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: ocular, including inherited retinal diseases and large degenerative 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.

Contacts

Investors:
MeiraGTx
Investors@meiragtx.com

Media:
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com

 


FAQ

What are the details of MeiraGTx's Phase 1 AQUAx clinical trial?

The AQUAx trial is an open-label, non-randomized, dose escalation study assessing the safety and efficacy of AAV-hAQP1 for radiation-induced xerostomia.

When is MeiraGTx hosting its R&D Day?

MeiraGTx will host its virtual R&D Day on December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET.

What is the purpose of the conference call on December 7, 2021?

The conference call will provide updates on the Phase 1 AQUAx clinical trial for AAV-hAQP1 and include a Q&A session.

What is AAV-hAQP1?

AAV-hAQP1 is an investigational gene therapy designed to treat radiation-induced xerostomia in patients who have undergone radiation therapy for head and neck cancer.

How does MeiraGTx's riboswitch gene regulation platform work?

MeiraGTx's riboswitch platform allows precise control of gene expression using small molecule inducers, offering potential for broad applications in genetic medicine.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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