Seelos Therapeutics To Test Trehalose In Patients With Rare Movement Control Disorder
The FDA has accepted Seelos Therapeutics Inc's (NASDAQ: 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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