US-based biotechnology company Puretech Health has begun a Phase IIa proof-of-concept clinical trial of LYT-300 using a validated clinical model of anxiety in healthy volunteers.

LYT-300 is an oral prodrug of allopregnanolone that uses the Glyph platform, which reversibly links allopregnanolone to a lipid and creates a new prodrug.

PureTech chief innovation officer Eric Elenko said: “Anxiety disorders are the most common mental disorder, impacting nearly 30% of adults at some point in their lives.

“Despite this, there has been very little clinical development in the last 20 years, especially when compared to other psychiatric conditions.

“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 (PPD) later this year.”

In a previous multi-part Phase I study, blood levels of allopregnanolone in PPD patients treated with oral LYT-300 showed a therapeutic benefit nine times greater than patients who were orally given allopregnanolone.

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By GlobalData

Results from the Phase IIa study are expected by the end of this year.

PureTech’s second therapeutic candidate, LYT-310 (oral cannabidiol), is expected to enter the clinic in the fourth quarter of this year.

Allopregnanolone and related endogenous neurosteroids are noted for their potential to treat depression and other neurological and neuropsychiatric indications with a rapid onset of action.

The main difficulties that have been associated with endogenous neurosteroids are their inability to create oral formulations and chronically administer them to patients.

Last week, PureTech reported findings from a Phase II clinical trial of LYT-100-COV (deupirfenidone) in post-acute long Covid patients with respiratory complications. 

LYT-100 is a selectively deuterated form of pirfenidone intended to maintain the potent anti-fibrotic and anti-inflammatory activity of pirfenidone.