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- Neuren Pharmaceuticals (NEU) and its U.S. partner, ACADIA Pharmaceuticals, have paused recruitment for their Lavender trial
- This Phase three trial was scheduled to test the use of Trofinetide in patients with Rett Syndrome, a neurological disorder that mostly affects females
- The decision to suspend recruitment was made to align with new measures in the U.S to combat the spread of COVID-19
- In addition, Neuren will postpone the commencement of its Phase two trial of its drug for Phelan-McDermid syndrome
- Shares in Neuren are down 9 per cent and are trading for $1.01
Neuren Pharmaceuticals (NEU) and its U.S. partner ACADIA Pharmaceuticals have paused recruitment for their Lavender trial.
The Lavender trial
This Phase 3 trial will test the use of Trofinetide in patients with Rett Syndrome, a neurological disorder that mostly affects females. People with Rett Syndrome experience difficulties with speech, coordination and speech and often require life-long care.
The 12-week study will enrol approximately 180 girls and women with Rett syndrome and between the ages of five and 20. Participants in the Lavender study are also eligible for an extension study, Lilac, which will evaluate long term tolerability, safety and effectiveness of the drug.
The decision by ACADIA to suspend recruitment for the Lavender trial was made to align with new measures in the U.S to combat the spread of COVID-19. Patients already enrolled in the study will not be impacted.
NNZ-2591 trial
Neuren will also postpone the commencement of its Phase two trial of NNZ-2591 for Phelan-McDermid syndrome. Neuren said current conditions make it extremely difficult to get the trial up and running before the end of 2020 and as such it will be deferred.
Once the situation improves, whenever that may be, the company plans to accelerate the commencement of the trial.
Meanwhile, Neuren’s non-clinical NNZ-2591 studies for its planned Investigational New Drug Application in the U.S are continuing and progressing on schedule.
Some of the characteristics of Phelan-McDermid include intellectual disability, delayed or absent speech, symptoms of autism, low muscle tone, motor delays and epilepsy.
The syndrome is caused by the deletion or mutation of the 22q13 region of chromosome 22. This region includes the SHANK3 gene which is essential to the production of a protein by the same name which supports the structure of synapses between brain cells.
Shares in Neuren were down nine per cent and trading for $1.01 each at 12:40 pm AEDT.
