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BOSTON - Seaport Therapeutics, a founded entity of PureTech Health plc (NASDAQ:PRTC, LSE:PRTC), has dosed the first participant in a Phase 1 clinical trial for GlyphAgo (SPT-320), according to a press release issued Thursday.
GlyphAgo is an oral prodrug of agomelatine being developed to treat generalized anxiety disorder (GAD). This marks the second therapeutic candidate from Seaport’s pipeline to advance into clinical development.
The Phase 1 study will evaluate safety, tolerability, and pharmacokinetics of GlyphAgo in healthy adult volunteers. The trial includes single and multiple-ascending dose phases and a food-effect crossover portion.
Agomelatine has demonstrated efficacy in GAD in previous studies but has been limited by liver-related side effects. Using Seaport’s proprietary Glyph platform, GlyphAgo is designed to shift absorption toward intestinal lymphatics, avoiding first-pass liver metabolism.
In preclinical studies, GlyphAgo showed over 50 percent of agomelatine being transported through mesenteric lymphatics versus less than one percent for agomelatine alone. The company reported that oral dosing of GlyphAgo increased plasma exposure of agomelatine by over 10-fold compared to agomelatine alone.
"The Phase 1 proof-of-concept study could be highly derisking for the GlyphAgo program, as agomelatine’s efficacy in GAD is already well established," said Antony Loebel, Chief Medical Officer and President of Clinical Development at Seaport Therapeutics, according to the press release.
GAD affects approximately 100 million adults worldwide, with no new drugs or mechanisms approved for GAD in the U.S. in decades, the company stated.
Seaport’s Glyph platform aims to enhance oral administration of drugs by enabling absorption through the intestinal lymphatic system, potentially addressing limitations of therapeutic molecules with high first-pass metabolism.
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