Brain biomarkers predicted response to PTSD drug in study

Key takeaways:

• The study found evidence ALTO-100 reduced PTSD symptoms with no new safety signals.
• Biomarkers identified by a precision medicine platform were associated with drug response.

Brain-based biomarkers of likely drug response were associated with a greater mean reduction in reported PTSD symptoms in a study of patients treated with ALTO-100.

Alto Neuroscience said in a press release that the topline results indicate that its drug ALTO-100 was safe and effective in patients with PTSD. The study also provides evidence the company’s precision medicine platform can match drugs to patients who would benefit from them, according to the release.

Positive results from another arm of the study examining ALTO-100 in major depressive disorder (MDD) were announced in January.

“This result in PTSD, leveraging the same biomarker as discovered in MDD, strengthens confidence in Alto’s approach and the replicability of our data,” Alto Neuroscience founder and CEO Amit Etkin, MD, PhD, said. “These data move us closer to transforming neuropsychiatric treatment through a robust understanding of biological drivers of treatment response at the level of individual patients.”

The study measured PTSD symptoms before and after treatment using the CAPS-5 questionnaire. Alto’s Precision Psychiatry Platform identified patients with a cognitive profile likely to respond to ALTO-100 by analyzing EEG activity, behavioral task performance, wearable data and genetics, among other factors.

At 4 weeks, patients with biomarkers for likely response (n = 44) had a 17.5-point mean reduction in CAPS-5 score, compared with a 12.9-point mean reduction in the non-biomarker group (n = 40) (P = .04). In the biomarker group, 46% of patients had a clinical response, defined as a 50% or greater score reduction, vs. 26% of those in the non-biomarker group.

The study found that ALTO-100 had a “favorable safety and tolerability profile” with “no new safety signals,” according to the release.

Etkin said the study’s findings “suggest the potential to meaningfully de-risk future development in additional indications.”

Reference:

• Alto Neuroscience announces positive results for ALTO-100 in phase 2 study supporting advancement of first-in-class mechanism for treating depression. https://www.altoneuroscience.com/press-releases/alto-neuroscience-announces-positive-results-for-alto-100-in-phase-2-study-supporting-advancement-of-first-in-class-mechanism-for-treating-depression. Published Jan. 10, 2023. Accessed Oct. 4, 2023.