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Prtc S Sptx New Positive Glyphago Ph1 Dosing Data

UpdatessympathyMajor Depressive DisorderScienceMilitary Title Officer

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Seaport Therapeutics announced positive results from a Phase 1 clinical trial evaluating repeat dosing of its drug candidate, GlyphAgo™, in healthy volunteers. The multiple-ascending dose (MAD) data confirmed that repeated dosing maintained a favorable safety and pharmacokinetic profile compared to previous single-dose studies. These findings support the company's plan to advance GlyphAgo into two parallel Phase 2 trials for treating generalized anxiety disorder (GAD).

Key points

  • GlyphAgo™, an oral prodrug of agomelatine, was tested in a repeat dosing study (MAD portion) during a Phase 1 trial.
  • The MAD data showed that seven-day dosing achieved therapeutic levels of agomelatine while reducing the risk and need for liver function testing.
  • Positive safety and pharmacokinetic profiles support advancing GlyphAgo into two parallel Phase 2 trials for GAD.
  • Phase 2a is planned for the second half of 2026, focusing on objective measures of sleep architecture in GAD patients.
  • Phase 2b, a potentially registration-enabling trial, is expected to begin in the first half of 2027.

Claims assessed

  • VerifiableRepeat dosing of GlyphAgo demonstrated safety and tolerability consistent with previous single-dose studies.
  • VerifiableThe drug candidate, GlyphAgo™, achieved therapeutic exposures of agomelatine at doses that reduce liver enzyme elevations.
  • VerifiableSeaport plans to initiate a Phase 2a trial in the second half of 2026 and expect top-line data in early 2028.

Missing context

The article does not provide the specific primary endpoints or statistical significance data from the Phase 1 MAD portion of the trial, nor does it detail the current competitive landscape for treating generalized anxiety disorder (GAD).

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