| 2019-07-17 09:02:22|
SEEL 09:02 07/17 07/17/19
Seelos Therapeutics announces IND application submission for SLS-005
Seelos Therapeutic announced that it has submitted an Investigational New Drug application with the U.S. Food and Drug Administration for the initiation of a Phase IIb/III clinical study of SLS-005 for the treatment of Sanfilippo syndrome. Seelos is working in collaboration and under a grant with Team Sanfilippo Foundation, a nonprofit foundation founded by parents of children with Sanfilippo syndrome. In May, Seelos announced the intention to expand this IND to be a combined Phase IIb/III, multicenter study designed to assess safety, tolerability and efficacy of trehalose IV in Sanfilippo A and B based on functional outcomes, biomarkers, neuro-cognitive assessments and quality of life measurements. Additionally, based on an overwhelming response from the Sanfilippo community worldwide, TSF, in collaboration with Seelos Therapeutics, has decided to expand inclusion of Sanfilippo type C and D patients as well as type A and B patients who do not meet the trial entry criteria into a separate expanded patient access study.