PureTech's Seaport advancing anxiety drug to Phase 2 on positive trial data

PureTech Health reported that its founded entity, Seaport Therapeutics (NASDAQ:SPTX), achieved positive clinical results from the multiple-ascending dose portion of its Phase 1 proof-of-concept trial evaluating its lead anti-anxiety candidate, GlyphAgo.

The successful data package clears the path for the biopharmaceutical company to advance the novel drug into two parallel Phase 2 clinical trials targeting patients with generalized anxiety disorder.

The trial evaluated repeat dosing of GlyphAgo, also known as SPT-320, which is an oral prodrug of agomelatine designed using Seaport's proprietary technology.

According to the company, the repeat-dosing regimen in healthy volunteers demonstrated a safety, tolerability, and pharmacokinetic profile that closely aligned with previously reported single-ascending dose and crossover data.

The underlying Glyph platform, which was originally incubated and developed at London-listed PureTech, is engineered to enhance the oral bioavailability of molecules by routing them through the lymphatic system.

This alternative absorption mechanism is designed to bypass the liver's first-pass metabolism, potentially overcoming historical limitations such as low absorption rates or dose-dependent side effects associated with unmodified compounds.

Following the initial clinical validation, Seaport plans to initiate a randomized, double-blind Phase 2a proof-of-pharmacology trial in the second half of 2026.

This mid-stage study will evaluate two distinct dose levels of the drug to characterize its potential benefits on sleep architecture among generalized anxiety disorder patients who experience sleep disturbances.

Topline results from this initial Phase 2a trial are projected to be available in early 2028.

In parallel, Seaport is preparing to launch a larger Phase 2b trial during the first half of 2027.

This second study will be a randomized, double-blind, placebo-controlled trial designed to serve as a potentially registration-enabling study to formally evaluate the overall efficacy and safety of GlyphAgo in a broader patient population with generalized anxiety disorder.

Corporate timelines indicate that topline data from the Phase 2b trial are anticipated by the end of 2028, marking the next critical inflection point for PureTech's hub-and-spoke development pipeline.