The study will assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of ALTO-203 in patients with major depressive disorder. Credit: Love Solutions / Shutterstock.

Alto Neuroscience has commenced a Phase II clinical trial of histamine H3 receptor inverse agonist, ALTO-203, in treating patients with major depressive disorder (MDD).

The double-blind, single-dose and multiple-dose study will assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of two doses of the ALTO-203 monotherapy versus placebo.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

This trial is structured into two sequential double-blind, placebo-controlled treatment periods.

The initial phase will employ a randomised, single-dose treatment design, focusing on the pharmacodynamic responses of the trial subjects to ALTO-203 versus placebo.

An acute change in positive emotion evaluated using the Bond-Lader Visual Analog Scale (BL-VAS), a recognised scale for subjective feelings, will be the trial’s primary outcome.

See Also:

Following the single-dose period, a 28-day multi-dose exposure phase will commence to further analyse the safety profile of the therapy in MDD patients.

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.

This second part of the study will also explore changes in depression severity, anhedonia, and other clinical symptoms, as well as cognitive functions.

Approximately 60 adult MDD patients with evidence of anhedonia will be enrolled in the trial.

The company anticipates reporting topline data from this study in the first half of next year.

Alto Neuroscience chief development officer Jessica Powell said: “This is the fifth Phase II study we have initiated across our pipeline, a milestone that marks significant progress in our efforts to redefine mental healthcare through our Precision Psychiatry Platform.

“In a Phase I study, ALTO-203 demonstrated an acute increase in positive emotion relative to placebo and across several dosage levels. We look forward to completing this proof-of-concept study in patients as we believe this response may be an important attribute of an antidepressant to benefit patients with MDD and higher levels of anhedonia specifically.”

Last November, the company secured $45m in a Series C financing round.