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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.