Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AAV2hAQP1: 1 x 10^11 vg/gland · 1 trial · 3 indications
Safety will be assessed by number of adverse events occurring with treatment
| Arm | Type | Description |
|---|---|---|
| 1 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^10 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (both glands) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AAV2hAQP1: 1 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^10 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^10 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 of via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^11 vg/gland (both glands) | DRUG | intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^12 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^12 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^12 vg/gland |
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. History of radiation therapy for head and neck cancer. 3. Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland \>0 and ...
AAV2hAQP1: 1 x 10^11 vg/gland is being studied for radiation-induced parotid gland hypofunction and xerostomia in patients who received radiotherapy for head and neck cancer. It is an investigational gene therapy designed to restore salivary gland function in this oncology setting.
AAV2hAQP1: 1 x 10^11 vg/gland is being developed by MeiraGTx Holdings plc, which trades on the Nasdaq under the ticker MGTX. The company is the sponsor of the clinical program for this gene therapy candidate.
AAV2hAQP1: 1 x 10^11 vg/gland is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 trial has been completed.
AAV2hAQP1: 1 x 10^11 vg/gland has been evaluated in one clinical trial, NCT04043104, a Phase 1 open-label, dose escalation study. The trial enrolled 24 participants across the United States and Canada and is now completed.
AAV2hAQP1: 1 x 10^11 vg/gland has received three FDA designations: Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Breakthrough Therapy. These designations support the development of the therapy for radiation-induced parotid gland hypofunction.