LYT-300 achieves statistically significant stress hormone reduction in phase 2a trial

Key takeaways:

• LYT-300 achieved the primary endpoint in a proof-of-concept trial.
• The trial was designed to evaluate the stress hormone response, which was measured by salivary cortisol.

LYT-300, a therapeutic for anxiety disorders, has achieved topline results in a phase 2a, randomized, placebo-controlled, proof-of-concept trial, the manufacturer announced in a press release.

LYT-300, an oral prodrug of allopregnanolone, demonstrated “a statistically significant reduction versus placebo in the increase from baseline to peak levels of the stress hormone salivary cortisol (P = 0.0001),” PureTech Health said in the press release.

The company reported that the LYT-300 treatment effect size versus placebo was 0.72, which is a similar effect size to previously observed results for alprazolam, a benzodiazepine drug indicated for treatment of anxiety disorders.

“The data generated with PureTech's LYT-300 suggest this may be a promising treatment for anxiety disorders, as well as a range of related neurological and neuropsychiatric conditions,” Maurizio Fava, MD, psychiatrist-in-chief at Massachusetts General Hospital and an adviser to PureTech, said in the release.

The company also reported that LYT-300 was well-tolerated, with all treatment-related adverse events being transient, mild or moderate and consistent with the known pharmacology profile of allopregnanolone.