Biotech firm to begin phase 2a trials of treatment for anxiety, postpartum depression

A biotechnology company has announced it will begin two phase 2a clinical trials will begin this year to assess the effectiveness of oral allopregnanolone in social anxiety and postpartum depression, according to a press release.

The first trial will evaluate the effect of oral allopregnanolone (LYT-300; PureTech Health) vs. placebo in a clinical model simulating social anxiety. About 50 participants are expected to enroll for the start of the trial in the first half of 2023. Results are expected by the end of the calendar year.

The second will be an open-label trial of LYT-300 in patients with moderate to severe postpartum depression. This follows results from a phase 1 trial announced in December that showed LYT-300 “achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit in postpartum depression,” according to the release.

“We believe LYT-300 is the most advanced oral prodrug of natural allopregnanolone and, as such, has the potential to unlock the full therapeutic benefit of allopregnanolone,” Julie Krop, MD, chief medical officer at PureTech, said in the release. “Using our proprietary Glyph platform, we have made natural allopregnanolone orally bioavailable without permanently chemically modifying the natural neurosteroid. This differentiated approach, which harnesses the validated, fast-acting efficacy of allopregnanolone, may offer an enhanced therapeutic benefit to patients with a wide range of neurological and neuropsychiatric conditions, including anxiety and postpartum depression.”