Policy & Regulation
PureTech's LYT-300 meets primary endpoint in Phase 2a anxiety trial
14 November 2023 -

Biotherapeutics company PureTech Health plc (Nasdaq: PRTC) (LSE: PRTC) reported on Tuesday positive results from its Phase 2a trial of LYT-300 (oral allopregnanolone) in anxiety. LYT-300 demonstrated a statistically significant reduction (p=0.0001) in salivary cortisol, indicating a potential treatment for anxiety disorders.

The trial's success supports LYT-300's development as a novel therapeutic addressing drawbacks in current anxiety treatments. With 30% of U.S. adults affected by anxiety disorders, LYT-300 aims to offer improved efficacy and tolerability.

LYT-300, an oral prodrug of allopregnanolone, showed a similar effect size to alprazolam, a benzodiazepine drug for anxiety disorders. The Phase 2a trial included 80 healthy volunteers and demonstrated LYT-300's well-tolerated profile.

PureTech plans further studies in 2024, aligning with its strategy in anxiety-related indications. The results affirm PureTech's Glyph platform, emphasizing its potential to enhance oral drug bioavailability.

Developed using PureTech's Glyph technology platform, LYT-300 is an oral prodrug of endogenous allopregnanolone. The trial's success reinforces the Glyph platform's ability to enable oral administration of therapeutics. PureTech is advancing a Glyph portfolio, focusing on improving oral bioavailability for various drugs.

PureTech has a pipeline of 27 therapeutics and candidates, including FDA-cleared Plenity and EndeavorRx, with KarXT filed for FDA approval. The company's R&D engine drives internal and Founded Entity programs, positioning it at various stages of clinical development.

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