- The FDA has accepted Seelos Therapeutics Inc's SEEL Investigation New Drug application to study SLS-005 (trehalose injection, 90.5 mg/mL) for spinocerebellar Ataxia (SCA).
- The FDA has also granted the program Fast Track designation for SCA, and SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and the European Medicines Agency.
- The Company plans to initiate Phase 2b/3 study in early 2022.
- SLS-005 had already been studied in a six-month Phase 2a study that included an additional six-month follow-up in patients with SCA3.
- The study evaluated 14 patients and found that the average score on the ataxia functional impairment scale remained stable.
- SCA is caused by degeneration of the cerebellum and is characterized by progressive unsteadiness of gait & stance, impaired limb movement coordination, slurred speech, and abnormal eye movements.
- Related Link: Seelos Therapeutics Shares Gain On FDA Approval To Add SLS-005 Regimen In HEALEY ALS Trial.
- Price Action: SEEL shares are up 1.36% at $2.24 during the premarket session on the last check Monday.
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