Alto has also initiated a Phase IIb trial for ALTO-300 in patients with MDD, with data readout planned in H1 FY 2025. Image Credit: Chanintorn.v / Shutterstock.

Alto Neuroscience reported positive results on a predictive biomarker and efficacy of ALTO-300 in a Phase II trial in patients with major depressive disorder (MDD).

The patients treated with ALTO-300 and characterised by an electroencephalogram (EEG) biomarker demonstrated clinical improvement in depression symptoms and higher response rates compared to patients without the EEG biomarker.

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The improvement in depression symptoms was measured using the Montgomery–Åsberg Depression Rating Scale (MADRS).

The placebo-controlled Phase II trial (NCT05922878) enrolled 239 MDD patients aged 18-74 years. Of these, 110 patients underwent EEG at baseline. This data was analysed using a machine learning algorithm to predict a drug’s antidepressant clinical efficacy.

The 55 patients with identified EEG biomarkers showed an 8.3-point reduction in MADRS, signifying an improvement in depression symptoms, compared to a 5.7-point reduction in the patient group without the biomarker profile at eight weeks.

In the independent test data set, there was an 11-point reduction in MADRS in the EEG biomarker group from week four to week eight compared to a 7.8-point reduction in the patient group without the biomarker profile.

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A clinical response of over 50% reduction in depression symptoms was seen in 47% of patients with EEG biomarkers compared to 27% of patients without biomarker profiles at week four. The response was sustained at week eight, with 62% and 47% of the patients with and without EEG markers, respectively, demonstrating a clinical response.

Alto added that the EEG biomarker was specific to ALTO-300 and did not predict responses in patients taking either placebo or selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), which are standard-of-care treatments for MDD.

Alto has used artificial intelligence (AI) to develop its drug pipeline. The increased use of AI has been a growing trend in the health sector. GlobalData forecasts predict that the AI market will reach sales of $93bn in 2023.

GlobalData is the parent company of Clinical Trials Arena.

Alto has also initiated a Phase IIb trial for ALTO-300 in patients with MDD. The trial is expected to enrol 200 patients, with data readout planned for H1 FY 2025.

In November, the US-based company raised $45m in series C funding. The financing was planned to go towards the advancement of Alto’s central nervous system candidates, including the anti-depressants ALTO-100, ALTO-202 and ALTO-300, along with the post-traumatic stress disorder therapy ALTO-100.