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.
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.
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.
