MeiraGTx Holdings plc
released data from the completed Phase 1 AQUAx study of AAV2-hAQP1 for grade 2/3 radiation-induced xerostomia (RIX), which includes the final 12-month data from all bilaterally treated participants.
Xerostomia refers to the sensation of oral dryness, which can result from diminished saliva production.
Clinically meaningful improvements in xerostomia symptoms were observed, measured by two different xerostomia PROs demonstrated across unilaterally and bilaterally treated cohorts at 12 months.
Increases in whole saliva flow rates were seen post-treatment, providing objective evidence of biological activity, reaching the normal range in bilaterally treated participants by two months and persisting through the Month 12 assessment.
Early long-term follow-up data suggest durability of improvement to at least three years post-treatment.
AAV2-hAQP1 appears safe and well tolerated at each dose tested.
The company has initiated a Phase 2 randomized, double-blind, placebo-controlled study with participants currently being dosed.
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