Seaport Therapeutics Reports Positive Multiple-Ascending Dose Data from Phase 1 Proof-of-Concept Trial of GlyphAgo in Healthy Volunteers

Seaport Therapeutics, Inc., (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company that is inventing and developing novel neuropsychiatric medicines, today announced positive data from the multiple-ascending dose (MAD) 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. Repeat dosing of GlyphAgo demonstrated a safety, tolerability, and pharmacokinetic (PK) profile consistent with previously reported single-ascending dose (SAD) and crossover data, supporting its planned development in patients with generalized anxiety disorder (GAD).

The MAD data showed that seven-day dosing of GlyphAgo achieved therapeutic exposures of agomelatine at doses that reduce liver exposure and are projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing that has previously limited agomelatine’s clinical use. GlyphAgo AUC_0-24 and Cmax increased dose-dependently over the range of doses studied, and agomelatine exposures following GlyphAgo administration in the MAD portion were consistent with data from the SAD and crossover portions of the trial. There was no unmodified agomelatine arm in the MAD portion.

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, further supporting observations from the SAD and crossover cohorts.

“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,” said Daphne Zohar, Co-Founder and Chief Executive Officer of Seaport Therapeutics. “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.”

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