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Gene therapy could restore saliva flow in dry mouth sufferers

NCT ID NCT05926765

Disease control Sponsor: MeiraGTx, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests a gene therapy (AAV2-hAQP1) injected into the saliva glands to see if it can safely increase saliva production in people with long-term dry mouth after radiation for head and neck cancer. About 276 adults who completed radiation at least 3 years ago will receive either the gene therapy or a placebo. The main goal is to measure changes in dry mouth symptoms and saliva flow over 12 months.

Why investors are watching

MeiraGTx Holdings plc is running a Phase 2 trial of AAV2-hAQP1 gene therapy for radiation-induced dry mouth, a condition with no good treatments. For a micro-cap company, this mid-stage readout on 290 patients is a major value driver, because a positive result would validate its gene therapy platform in a new disease area. The trial is run by MeiraGTx, LLC, part of MeiraGTx Holdings plc.

If it works: A positive result could show the therapy safely restores saliva production, potentially leading to a larger Phase 3 study and a path to market. That success would strengthen MeiraGTx's pipeline and its position in gene therapy for non-rare diseases.

If it fails: Phase 2 trials often fail to show a clear benefit over placebo, and a negative or mixed result could delay or end the program. For a small company, such a setback could hurt its stock and force it to rely on other pipeline assets.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

290 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit * No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma * An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube) * A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing * Average screening XQ Total Score at or above a specified threshold * No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of signing the informed consent form (and at least 3 years after the completion of radiotherapy), then that scan may be used for eligibility determination and a CT scan at screening will not be required. If the CT of the neck captures images from the forehead down to the neck, no CT of the head is required. * Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected not to initiate such treatment * Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study * Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit Exclusion Criteria: * History of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma * History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren's disease) * Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or biologics) or treated with one within 4 weeks of the first screening visit. Note: Topical, inhaled, or intranasal corticosteroids are permitted. * Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA IgM. In the event a potential participant has a positive anti-VCA IgM, they may be rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear Antigen (EBNA) will be considered as evidence of resolved EBV infection. * Evidence of active Hepatitis C virus (HCV) infection * Evidence of human immunodeficiency virus (HIV) infection * Diagnosis of myasthenia gravis * Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at increased risk of developing ACG, or had prophylactic treatment to reduce the risk of developing ACG * Known allergy or hypersensitivity to glycopyrrolate * Current smokers or history of smoking within the preceding 3 years (includes vaping with tobacco additives) * Current alcohol misuse or a history of the same within the preceding 3 years, as defined by local guidance. In North America, an average intake for men of more than 14 drinks per week, and for women more than 7 drinks per week, consistent with the US National Institute of Alcohol Abuse and Alcoholism. In the UK, an average intake of more than 14 units per week for both men and women, consistent with the UK Chief Medical Officers' Low Risk Drinking Guidelines. * Poorly controlled diabetes (hemoglobin A1c \>7%)

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Grade 2 and 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract, excluding the parotid glands

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

  • CIUSSS-MCQ (Trois-Rivières, QC)

    Trois-Rivières, G8Z 3R9, Canada

  • Cardiff and Vale NHS Trust - Head & Neck Services

    Cardiff, CF14 4XW, United Kingdom

  • City of Hope

    Duarte, California, 91010, United States

  • Erie County Medical Center

    Buffalo, New York, 14215, United States

  • Glasgow Royal Infirmary

    Glasgow, LS2 9LU, United Kingdom

  • Guys Hospital

    London, SE1 9RT, United Kingdom

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hopital Fleurimont, CIUSSS de l'Estrie-CHUS

    Québec, J1H 5HE, Canada

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21231, United States

  • Johnson City Medical Center

    Johnson City, Tennessee, 37604, United States

  • Leeds Dental Institute

    Leeds, LS2 9LU, United Kingdom

  • Miami Cancer Institute at Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY, United Kingdom

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Penn State

    Hershey, Pennsylvania, 17033, United States

  • Princess Margaret Cancer Centre

    Toronto, M5G 2C4, Canada

  • Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • The Royal Marsden

    London, SW3 6JJ, United Kingdom

  • Tufts University School of Dental Medicine

    Boston, Massachusetts, 02111, United States

  • UNC-Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University College London Hospitals NHS Foundation Trust

    London, WC1E 6DG, United Kingdom

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • Washington University - St. Louis

    St Louis, Missouri, 63110, United States

  • Western General

    London, EH4 2XU, United Kingdom

  • York Hospital

    York, YO31 8HE, United Kingdom

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