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Pharnext Reports the Completion of Patient Enrollment in the P-III (PREMIER) Trial of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A

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Pharnext Reports the Completion of Patient Enrollment in the P-III (PREMIER) Trial of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A

Shots:

  • The company has completed patient enrollment in the P-III (PREMIER) trial to evaluate PXT3003 (BID) vs PBO in 387 patients with CMT1A for 15mos. at 52 centers across the US, Canada, EU & Israel. The results are expected in Q4’23
  • PXT3003 dose corresponds to the high dose used in the prior P-III (PLEO-CMT) & ongoing P-III (PLEOCMT-FU) OLE trial. The 1EPs will be the ONLS that measures functional motor disability & 2EPs include 10mWT, QMT, PGI-S, PGI-C & CMTNS-v2. The safety & tolerability will also be assessed
  • PXT3003 is a fixed-dose synergistic combination of baclofen, naltrexone & sorbitol formulated as an oral solution. In P-II (PLEO-CMT) & P-III (PLEO-CMT-FU) trials, PXT3003 showed an encouraging & consistent results

Ref: Pharnext | Image: Pharnext

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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