Monash University‘s unique drug technology, created with PureTech Health, hits a milestone in a Phase 2a trial. The trial of ‘LYT-300,’ an oral form of Allopregnanolone, showed a notable reduction in stress hormones among healthy volunteers, marking a significant success in the study.
In a study evaluating stress response in the Trier Social Stress Test, eighty volunteers received either LYT-300 or a placebo. Administered orally, LYT-300 successfully reduced peak cortisol levels in saliva, an essential stress hormone, in a statistically significant manner compared to the placebo (p=0.0001).
LYT-300 demonstrated a similar effect to alprazolam, a benzodiazepine used for anxiety, but with different pharmacology as it is based on an endogenous neurosteroid. The technology behind LYT-300 comes from PureTech’s GlyphTM platform, initially developed at Monash Institute of Pharmaceutical Sciences and licensed to PureTech Health in 2017.
Professor Porter said, “Allopregnanolone has been recognized for its potential to treat a range of neurological and neuropsychiatric indications and has a well-established rapid onset of action in mood disorders. However, historically, major hurdles have been associated with the development of endogenous neurosteroids as medicines. Most notably, there is a lack of oral bioavailability and a need to administer intravenously. This makes convenient dosing to patients over an extended period in chronic diseases complicated,”
According to Professor Porter, the Glyph platform uses the body’s natural process of lipid absorption and transport to enable oral administration of therapeutics like allopregnanolone. This innovation suggests that LYT-300 could become a simple oral capsule for anxiety, addressing a need for innovation in anxiety treatment. Dr. Murray Stein, an advisor to PureTech, highlights the importance of reducing stress over-reactivity, as seen in cortisol levels, in treating anxiety and stress-related disorders, emphasizing the potential benefits of LYT-300 in this context.
LYT-300, a non-benzodiazepine neurosteroid, effectively reduces the stress response, showcasing its unique pharmacology and potential as a new treatment option for patients in serious need. In the trial, LYT-300 showed good tolerance, with any related adverse events being mild or moderate and consistent with the known profile of allopregnanolone. More details from the study will be shared in a scientific forum.
The Phase 2a clinical trial results showcase the potential of Monash’s LYT-300 as a breakthrough in anxiety treatment. Its ability to significantly reduce stress hormone response, combined with its novel pharmacology and favorable safety profile, positions LYT-300 as a promising candidate for individuals in need of innovative and effective anxiety disorder treatments. Further insights from the study will be shared in upcoming scientific forums, providing additional depth to the promising findings.