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news.Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, is pleased to announce the acceptance of the Investigation New Drug (IND) application for SLS-005 (trehalose) by the Food and Drug Administration (FDA).
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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The FDA has advised Seelos that it may proceed with the proposed clinical trial SLS-005-201 for Mucopolysaccharidosis type III (Sanfilippo syndrome).
“We are very pleased to have received the acceptance letter and continue to work closely with the FDA to finalize the details of the analysis methodology for primary and secondary endpoints to demonstrate efficacy of trehalose in Sanfilippo syndrome,” said Warren W. Wasiewski, M.D., F.A.A.P., Chief Medical Officer of Seelos. “Due to support and interest from families of patients with Sanfilippo, we continue to engage with additional clinical trial sites to accommodate enrollment for this trial.”
“This is a great milestone for Seelos and outlines the dedication and hard work of our clinical team under the leadership of Dr. Warren Wasiewski, our CMO,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics. “We are grateful for the detailed guidance from the regulatory agency (FDA) and thank our financial supporter and collaborator, TSF, that has brought a singular focus to helping the Sanfilippo community.”
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.
Source: Company Press Release
