Posted: 27 July 2023
A unique drug delivery platform developed by Monash University researchers in partnership with PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), has reached another exciting milestone, with the initiation of a Phase 2a clinical trial of LYT-300 (oral allopregnanolone) in healthy volunteers using a validated clinical model of anxiety, with results anticipated by the end of 2023.
LYT-300 is an oral prodrug of allopregnanolone that employs PureTech’s GlyphTM platform. The Glyph technology was initially developed by Professor Chris Porter and his team at the Monash Institute of Pharmaceutical Sciences (MIPS) and exclusively licensed to PureTech Health in 2017.
Allopregnanolone and related endogenous neurosteroids have been recognized for their potential to treat depression and other neurological and neuropsychiatric indications with a rapid onset of action. The use of allopregnanolone, however, is limited by negligible oral bioavailability and is currently only approved as a 60-hour intravenous infusion for the treatment of post-partum depression (PPD). This delivery method is likely to limit broader application.
The Glyph platform harnesses the body’s natural lipid absorption and transport process to enable the oral administration of therapeutics like allopregnanolone that otherwise cannot be administered orally.
Topline results from a Phase 1 trial of LYT-300 were announced in December 2022 and showed that oral administration of LYT-300 resulted in blood levels of allopregnanolone at or above those associated with therapeutic benefit in PPD and ninefold greater than orally administered allopregnanolone, based on third-party published data1. The results also demonstrated exposure-dependent target engagement with γ-aminobutyric-acid type A (GABAA) receptors, which have been shown to regulate mood and other neurological conditions.
“Despite the prevalence of anxiety disorders throughout the community, few advancements in new safe and effective treatments have emerged over the last 20 years,” said Professor Porter. “It is our hope that LYT-300 will become a simple oral capsule that is able to treat a range of neurological conditions including anxiety and PPD.”
Eric Elenko, Ph.D., Chief Innovation Officer at PureTech, said “We believe that our Glyph technology platform is positioned to unlock the therapeutic potential of a range of molecules, beginning with allopregnanolone, and we look forward to the results of this study as well as the initiation of a study with LYT-300 in postpartum depression later this year.”
Results for the placebo-controlled, Phase 2a, proof-of-concept trial using a validated clinical model of anxiety in healthy volunteers are anticipated by the end of 2023. Additionally, the open-label, Phase 2a, proof-of-concept clinical trial in patients with postpartum depression is expected to begin in the second half of 2023.
