Neuren (ASX:NEU) initiates Phase 2 trials of NNZ-2591

August 08, 2022 04:19 PM AEST | By Aditi Sarkar

Neuren (ASX:NEU) initiates Phase 2 trials of NNZ-2591 — Image source: © Alfaphoto9 | Megapixl.com

PMS and PTHS

Image Source: © Mjbowra | Megapixl.com

PMS and PTHS are serious neurological disorders that affects both sexes. These disorders appear in early childhood and impact almost every part of life. Further, they do not have any approved medicines.

PMS characteristics include speech problems, intellectual disability, epilepsy, etc. PTHS is a neurodevelopmental condition with symptoms including behavioural differences, developmental delay, gastrointestinal problems, sleep disturbance, etc.

Safety, tolerability, pharmacokinetics, and efficacy

The first subjects of the trial are expected to enter the trial imminently at Rush University Medical Center in Chicago, with results anticipated in H1 2023. Both these Phase 2 trials are aimed at generating information to update the design of a successive registration trial.

Besides tolerability and safety, the primary results of the trial reflect standard pharmacokinetic elements as well as severity, frequency and incidence of adverse events.

Secondary outcome measures are different kinds of exploratory efficiency measures for each syndrome. Recently, Neuren initiated a Phase 2 trial of NNZ-2591 in Angelman syndrome (AS) and is also implementing the preliminary work to prepare for Phase 3 development in different indications.

Stock information

Shares of Neuren were trading at AU$5.710 (as on 03:23 PM AEST on 08 August 2022). The company has a market capitalisation of AU$702.86 million.

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