During the meeting, the Company and MHRA discussed the data package and manufacturing requirements to support a MAA submission for AMT-130. Following these discussions, the Company expects to submit a MAA based on the three-year analysis from the ongoing U.S. and European Phase I/II clinical trials. At year three, these data showed a statistically significant 75% slowing of disease progression at the high dose as measured by the composite Unified Huntington's Disease Rating Scale compared to a propensity score-matched external control (p=.003) and was generally well-tolerated, with a manageable safety profile.
In addition to the continued engagement with the MHRA, the Company has been granted a Type B meeting with the U.S. Food and Drug Administration in the second quarter of 2026. The Company expects to discuss key elements of a potential Phase III trial design and to receive feedback on the proposed statistical analysis plan for the four-year analysis expected in the third quarter of 2026. The Company is also actively pursuing additional regulatory pathways in international markets for potential registration of AMT-130 and expects to provide further updates in the second half of 2026.
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