Biotherapeutic firm to commence phase 2a trial of oral anxiety treatment

Key takeaways:

• According to the manufacturer, LYT-300 holds the potential to treat disorders including anxiety and postpartum depression. Results of a study on treatment of anxiety are expected by the end of 2023.

A Boston-based biotherapeutics company has announced initiation of a phase 2a proof-of-concept clinical trial of an oral prodrug of endogenous allopregnanolone in healthy volunteers using a validated clinical model of anxiety.

According to a release from PureTech Health plc, LYT-300 holds the potential to treat a range of neurological and neuropsychiatric disorders including anxiety disorders and postpartum depression. LYT-300 was developed using PureTech's GlyphTM platform, which harnesses the body’s natural lipid absorption and transport process to facilitate oral intake of medication which otherwise could not be given by mouth, per the release.

“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,” Eric Elenko, PhD, chief innovation officer at PureTech, said in the release. “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.”

The FDA had previously approved a 60-hour IV formulation of allopregnanolone to treat PPD.

PureTech expects results for the ongoing placebo-controlled trial by the end of 2023, while a separate open-label, phase 2a, proof-of-concept clinical trial in patients with PPD is expected to begin in the latter half of this year.