Puretech Health has reported that its Phase IIa clinical trial of LYT-300 (oral allopregnanolone) to potentially treat acute anxiety met the primary endpoint

The proof-of-concept, placebo-controlled, randomised trial analysed the salivary cortisol response induced by LYT-300 based on the Trier Social Stress Test (TSST), an established anxiety clinical model.

The trial enrolled 80 healthy subjects who were randomised into a 1:1 ratio to receive either LYT-300 or a placebo. 

According to the trial’s topline data, oral LYT-300 offered a statistically significant decline in stress hormone response, as evaluated by salivary cortisol, compared to a placebo, meeting the primary endpoint. 

The effect size following the LYT-300 treatment compared to the placebo was 0.72. 

In addition, LYT-300 was found to be well tolerated, with mild or moderate drug-linked adverse events reported.

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By GlobalData

An oral endogenous allopregnanolone prodrug, LYT-300 is being developed for treating various neurological and neuropsychiatric ailments.

PureTech Health founder and CEO Daphne Zohar said: “These data validate that LYT-300 has potential to make a difference for people living with anxiety, where there’s been a dearth of innovation and existing treatments have drawbacks. 

“The successful outcome of this trial builds on our strategy of identifying drugs with proven clinical efficacy, but with historical limitations that have held back their therapeutic use, and then applying an innovative solution to enhance their potential for patients.”