Seaport Therapeutics (NASDAQ: SPTX) has announced positive data from the multiple-ascending dose portion of its Phase 1 proof-of-concept clinical trial evaluating repeat dosing of GlyphAgo (SPT-320), a novel, Glyphed oral prodrug of agomelatine, in healthy volunteers.
The trial, which included 174 participants, was conducted in multiple parts to evaluate the safety, tolerability, and PK of GlyphAgo and to compare the PK of GlyphAgo to agomelatine alone. According to Seaport, across all dose levels evaluated, GlyphAgo was well tolerated, with no serious or severe adverse events, no liver-related adverse events, and no clinically significant changes in liver-related laboratory parameters observed.
In a statement, Daphne Zohar, co-founder and CEO of Seaport, commented, “We are enthusiastic about the data from our Phase 1 program for GlyphAgo, where we’ve now observed consistent safety, tolerability, and PK across all cohorts. We believe these results substantially derisk our future clinical development approach and strengthen the differentiated profile of GlyphAgo. The complete Phase 1 data package further validates our Glyph platform and supports the advancement of GlyphAgo into two parallel Phase 2 trials as we work to bring a new treatment option to patients with generalized anxiety disorder who have not had a new medicine approved in almost 20 years.”
