Neuren Pharmaceuticals (ASX: NEU) is progressing Phase 2 trials for its NNZ-2566 treatment for four separate neurological disorders.
The Phase 2 trial for Fragile X Syndrome has commenced in the U.S. while the trial for Rett Syndrome has enrolled 36 subjects with the planned higher dose group commencing.
It has also recruited 131 subjects for the Phase 2 trial in Traumatic Brain Injury and is on track to start the Phase 2 Concussion trial in the first half of 2014.
All four conditions represent significant underserved markets, with no approved drug therapies currently available for patients.
Separately, the company has been granted a U.S. patent covering use of NNZ-2566 to treat cognitive and memory disorders. This expires in 2026.
The treatment is now covered by eight U.S. patents covering the composition, oral formulation and methods of use, with additional patent applications pending. One patent covering oral formulations of NNZ-2566 has also now been granted in Japan.
NNZ‐2566 is a synthetic analogue of a naturally occurring neuropeptide derived from IGF‐1, a growth factor produced by brain cells.
In animal models, NNZ‐2566 inhibits neuroinflammation and normalises the function of microglia with consequent improvements in molecular, cellular, anatomic and behavioural outcomes.
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