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Home » Spinogenix Receives FDA Orphan Drug Status for ALS Drug
Spinogenix Receives FDA Orphan Drug Status for ALS Drug
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The FDA has granted Spinogenix’s SPG302 Orphan Drug designation for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
The agency has approved a phase 1/2 study in ALS patients, followed by a phase 2/3 pivotal trial assuming positive safety, pharmacokinetic and biomarker data, the San Diego, Calif., drugmaker said.
SPG302 is an oral, small-molecule drug that can penetrate the blood-brain barrier and regenerate synapses. It has been shown to improve cognitive and motor behavior in animals with neurodegenerative disorders.
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