Seelos Therapeutics Announces European Medicines Agency Guidance to Design an Open-Label Pivotal Study for SLS-005 in Sanfilippo Syndrome
Seelos Therapeutics, Inc. (SEEL)
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Source: GlobeNewswire
NEW YORK, March 11, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced that it has received a written response from the European Medicines Agency (EMA), in lieu of a face to face meeting, offering guidance for Seelos’ planned European study of SLS-005 (IV trehalose) in patients with mucopolysaccharidosis type III (MPS III), also known as Sanfilippo syndrome. Based upon the written response from the EMA, Seelos will design an open-label, non-placebo controlled, Phase IIb/III pivotal study for the treatment of patients with Sanfilippo syndrome types A and B in the European Union (EU). “The EMA’s recommendation to use appropriate natural history data of Sanfilippo syndrome patients allows us to offer active therapy to all children enrolled in the study,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “This devastating
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Sec Filings
- 11/22/24 - Form NT
- 11/22/24 - Form 8-K
- 11/14/24 - Form SC
- SEEL's page on the SEC website