Unmet Medical Needs

Unmet medical needs for ALS fall into two categories: (1) improved means/methods for early diagnosis; and (2) improved medications. Diagnosis of ALS, especially nonfamilial disease, is difficult, and definitive diagnosis is often delayed for up to 1.5 years after symptom onset. This typically results from general practitioners not recognizing early signs of disease owing to the limited number of the patients that they encounter.

The paucity of approved treatments for ALS underscores the critical need for further research and drug development. Moreover, the limited clinical efficacy of riluzole warrants improved therapeutic treatments. Unfortunately, the lack of knowledge regarding the mechanism of action of riluzole has limited the potential for second-generation compounds within this drug class.

Since the approval of riluzole, at least 10 therapeutic approaches which showed promise in preclinical models have been tested in the clinic but have failed or shown equivocal results (such as for insulin-like growth factor-1). These include neurotrophic factor replacement strategies (ciliary neurotrophic factor, BDNF glial-derived neurotrophic factor, and insulin-like growth factor-1), glutamate/NMDA receptor antagonists (topiramate, dextromethorphan) or putative glutamate modulators (gabapentin, lamotrogine, N-acetylcysteine), antioxidants (vitamin E), MAO/glyceraldehyde phosphate dehydrogenase inhibitors (selegeline), and mitochondrial transition pore blockers (creatine).86'87'95 Insulinlike growth factor-1 has shown improvement in quality of life and benefit in ALS patients.97

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