Seelos Therapeutics announces FDA acceptance of IND application for SLS-005
Seelos Therapeutics announces the acceptance of the Investigation New Drug application for SLS-005 by the Food and Drug Administration. The FDA has advised Seelos that it may proceed with the proposed clinical trial SLS-005-201 for Mucopolysaccharidosis type III. The clinical trial for SLS-005-201 is 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, Seelos intends 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.