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[6] Fahmy S.F., El-Hamamsy M., Zaki O., Badary O.A
The NDA submission was partly based on topline results from the ongoing single location BHV4157-206-RWE study (NCT06529146), in which troriluzole 200 mg administered orally once daily led to a 5070% slower rate of decline from baseline in the functional Scale for the Assessment and Rating of Ataxia (f-SARA) in all SCA genotypes at 3 years compared to an external control arm. Data from the BHV4157-206 study (NCT03701399) also demonstrated disease stabilization in the SCA3 genotype and a reduction in falls in all SCA genotypes compared to placebo over 48 weeks. If approved, troriluzole will be the first and only medication indicated for the treatment of SCA
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Figure 3 Throughout our in vitro experiments, we exposed activated ILC2s to a pharmacological concentration (250M) of melatonin as has been shown previously to be maximally effective in driving phenotypic changes in T-cells without causing toxicity (43)
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