Amgen and Regeneron Pharmaceuticals' brain-derived neurotrophic factor,which was in Phase III clinical trials for the treatment of the neurodegenerative disease amyotrophic lateral sclerosis, did not demonstrate clinical efficacy in subcutaneous delivery. As a result, no further development of BDNF using this route of administration is planned, says the company.
Although the trial was seen to replicate both the safety and tolerability factors noted in previous trials, it also "showed no statistically significant or clinically relevant difference in breathing capacity or survival between treatment and placebo groups."
Early-stage clinical trials to investigate the use of BDNF for intrathecal administration in ALS, in Guillain Barre syndrome and for subcutaneous delivery in diabetic neuropathy will continue. According to Leonard Schleifer, president and chief executive officer of Regeneron, this is because there is still a belief that "neurotrophic factors have potential to benefit patients with neurological diseases," thus it will "continue its pursuit of intrathecal use of BDNF in patients with ALS and both BDNF and neurotrophin-3 for treatment of peripheral neuropathies."
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