Small Cap-MeiraGTx Reveals Encouraging Data From Parkinson's Study Showing Significant, Clinically Meaningful Changes in Key Efficacy Endpoints

Benzinga10-16

On Tuesday, MeiraGTx Holdings plc (NASDAQ:MGTX) released topline data from its clinical bridging study of AAV-GAD for Parkinson’s disease, MGT-GAD-025. MGT-GAD-025 is a 6-month, three-arm, randomized,...

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The primary objective of the study was to evaluate the safety and tolerability of AAV-GAD, with exploratory efficacy endpoints including the mean change from baseline to Week 26 in MDS-UPDRS Part 3  scores in the “off” state and the Parkinson’s Disease Questionnaire  score, a key patient-reported quality of life measure in Parkinson’s disease.AAV-GAD was safe and well tolerated, with no serious adverse events  related to AAV-GA","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"MGTX":"Meiragtx Holdings Plc","BK4139":"生物科技"},"translate_title":"小型股-MeiraGTx揭示了帕金森病研究的令人鼓舞的数据，显示关键疗效终点发生了显着的、具有临床意义的变化","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MGTX":0.9},"content_text":"On Tuesday, MeiraGTx Holdings plc (NASDAQ:MGTX) released topline data from its clinical bridging study of AAV-GAD for Parkinson’s disease, MGT-GAD-025.\nMGT-GAD-025 is a 6-month, three-arm, randomized, double-blind, sham-controlled study using AAV-GAD drug product manufactured by MeiraGTx at its wholly-owned facilities with its commercial platform process.\nParticipants had idiopathic Parkinson’s disease, a history of levodopa responsiveness for at least 12 months, and a UPDRS Part 3 score of ≥25 points in the “off” state.\nFourteen subjects were randomized to one of three groups (high dose n=5, low dose n=5, and sham n=4)\nThe primary objective of the study was to evaluate the safety and tolerability of AAV-GAD, with exploratory efficacy endpoints including the mean change from baseline to Week 26 in MDS-UPDRS Part 3 (motor examination) scores in the “off” state and the Parkinson’s Disease Questionnaire (PDQ-39) score, a key patient-reported quality of life measure in Parkinson’s disease.\nAAV-GAD was safe and well tolerated, with no serious adverse events (SAEs) related to AAV-GAD treatment.\nAt Week 26, the high-dose group demonstrated a statistically significant 18-point average improvement from baseline in the UPDRS Part 3 “off” medication score (p=0.03), with no significant change in the sham or low dose groups.\nSignificant improvements from baseline in the disease-specific, patient-reported quality of life PDQ-39 score were demonstrated in both the high and low-dose groups with no significant change in the sham group at Week 26:\n\nIn the high-dose AAV-GAD group, the PDQ-39 score improved by 8 points from baseline (p=0.02), the low-dose group improved by 6 points from baseline (p=0.04), while the 0.2 point worsening in the sham surgery group was not statistically significant.\nA dose-response in PDQ-39 score was observed, with 100% of participants in the high-dose group, 60% in the low-dose group, and 25% in the sham surgery group reporting an improvement.\nFor the PDQ-39 score, there was a trend to significance between the high dose and sham surgery groups at six months (n=4 evaluable per group).\n\nSubjects who completed this trial may enroll in a long-term follow-up study, in which they will be monitored for five years after treatment.\nPrice Action: MGTX stock is up 13.2% at $5.25 at last check Tuesday.\nRead Next:\n\nJohnson & Johnson’s Q3 Earnings: Revenue And EPS Beat On Strong Cancer Drug Sales, Revises Annual Outlook To Reflect V-Wave Acquisition.\n\nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nThis article Small Cap-MeiraGTx Reveals Encouraging Data From Parkinson's Study Showing Significant, Clinically Meaningful Changes in Key Efficacy Endpoints originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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