Selos Therapeutics Inc. (NASDAQ: SEEL) has announced that the FDA has accepted its Investigational New Drug application to evaluate SLS-005 (trehalose injection, 90.5mg/mL for intravenous fusion) in spinocerebellar ataxia (SCA) treatment.
SLS-005 awarded Fast Track designation
The regulatory agency gave SLS-005 Fast Track designation for SCA in the US. Previously, SLS-005 had received Orphan Drug designation from the FDA and the European Medicine Agency (EMA) in the EU for spinocerebellar ataxia type 3 (SCA3).
CEO and Chairman Raj Mehra said, “SCA is a highly debilitating neurodegenerative disease that currently lacks a cure or an approved therapeutic and as such, patients manage symptoms through physical therapy and other symptomatic treatments. SLS-005 has already displayed encouraging open label human data in SCA3, the most common type of SCA, and our team has taken that experience and knowledge into the design and plans for our global Phase IIb/III placebo-controlled study. We look forward to initiating this study in early 2022 and our recent capital raises have accounted for the expected development costs for initiating this study.”
SLS evaluated in SCA3 patients
SLS-005 had already been evaluated in a six-month open-label Phase IIa trial that included another six-month follow-up in SCA3 patients prior to Seelos acquiring the program. Over the course of six-month open-label research, 14 SCA3 patients were examined, and the average score on the Scale for Assessment and Rating of Ataxia (SARA) remained unchanged. Notably, six patients got treatment for up to a year, and their SARA scores remained steady. Thus, people with SCA3 should expect a substantial increase in SARA over the course of a year, indicating deteriorating symptoms and disease progression.
NAF Executive Director Andrew Rosen said, “On behalf of the National Ataxia Foundation and the ataxia community we represent, we’re thrilled that Seelos Therapeutics has received both IND acceptance and Fast Track designation from the FDA. In addition, Seelos is a founding member of the NAF Drug Development Collaborative and NAF looks forward to working closely with Seelos to support the company as its program progresses.”
