LOS ALTOS, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO) has launched a Phase 2 clinical study to evaluate the effects and safety profile of its drug candidate ALTO-203 in patients with major depressive disorder (MDD), particularly those experiencing high levels of anhedonia, the company announced today.
The investigational drug, ALTO-203, is a novel small molecule that functions as a histamine H3 receptor inverse agonist. It has previously shown promise in Phase 1 trials, demonstrating a favorable tolerability profile and the potential for positive emotional and cognitive effects in healthy participants after a single dose.
The current study is a double-blind, placebo-controlled trial involving two sequential treatment periods. Initially, a single-dose treatment design will measure the acute change in positive emotion using the Bond-Lader Visual Analog Scale, a tool for assessing subjective feelings. The second period will span 28 days of multiple-dose exposure to evaluate the long-term safety of ALTO-203 in MDD patients.
Approximately 60 adult participants with MDD and signs of anhedonia will be enrolled in the trial, with topline data expected to be reported in the first half of 2025. Further details regarding the study can be found on ClinicalTrials.gov.
Jessica Powell, chief development officer at Alto Neuroscience, highlighted the importance of the study, stating that the response observed in Phase 1 could be a significant attribute of an antidepressant for patients with MDD and anhedonia.
Alto Neuroscience aims to redefine mental healthcare by developing personalized and effective treatment options through its Precision Psychiatry Platform, which measures brain biomarkers using EEG activity, neurocognitive assessments, wearable data, and other factors to identify patients likely to respond to its drug candidates. The company's pipeline includes novel drugs for depression, PTSD, schizophrenia, and other mental health conditions.
The information in this article is based on a press release statement from Alto Neuroscience. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from projected outcomes.
InvestingPro Insights
As Alto Neuroscience, Inc. (NYSE: ANRO) advances its clinical study for ALTO-203, investors are closely monitoring the company's financial health and stock performance. With a market capitalization of $379.04 million, ANRO's financial position appears robust, holding more cash than debt on its balance sheet, which could be crucial in funding ongoing research and operations. Notably, ANRO's stock has experienced a significant decline over the past week, with a one-week price total return of -15.91%, reflecting market reactions to recent events or broader sector trends.
On the profitability front, ANRO faces challenges, as indicated by a negative P/E ratio of -1.58 and an adjusted P/E ratio for the last twelve months as of Q4 2023 of -10.44. This suggests that the company has not been profitable over the last year. However, ANRO's liquid assets exceed its short-term obligations, providing some financial flexibility in the near term. Investors should note that ANRO does not pay dividends, emphasizing the company's focus on reinvesting earnings into research and development.
For those interested in a deeper analysis, there are additional InvestingPro Tips available for ANRO, which reveal insights into metrics such as gross profit margins and the company's valuation against analyst targets. The InvestingPro Tips also highlight ANRO's current fair value estimation at $15.27, compared to analyst targets of $32.5. To access these insights, readers may visit InvestingPro and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. Alto Neuroscience's next earnings date is slated for May 29, 2024, which will be a key event for investors tracking the company's progress.
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