LOS ALTOS, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO) announced today that its Phase 1 study of ALTO-101, a novel transdermal PDE4 inhibitor, showed favorable tolerability and pharmacokinetics, suggesting potential benefits for treating cognitive impairment associated with schizophrenia (CIAS).
The study compared the transdermal delivery system developed with MEDRx to oral administration, with the transdermal method delivering higher drug concentrations and fewer adverse events.
The Phase 1 trial involved 15 adult participants who received both oral and transdermal doses of ALTO-101. The transdermal application led to a 62% and 170% increase in drug exposure on the first and second day, respectively, compared to oral administration.
Moreover, the maximum concentration on day 2 of transdermal dosing was comparable to that of the orally administered drug. Notably, the transdermal formulation maintained stable plasma concentrations over 24 hours.
Adverse events typically associated with PDE4 inhibitors, such as dizziness and nausea, were significantly reduced with the transdermal system. All reported adverse events were mild, with no serious adverse events or discontinuations due to adverse effects. The patch also demonstrated good adhesion properties without causing application site reactions.
These results indicate that ALTO-101 could offer a therapeutic option for CIAS patients, who currently have limited treatment choices. Amit Etkin, M.D., Ph.D., CEO of Alto Neuroscience, emphasized the importance of the transdermal system in reducing adverse events and providing stable drug concentrations.
Alto plans to initiate a proof-of-concept study for ALTO-101 in the first half of 2024, with topline data expected in the second half of 2025. The achievement of the desired pharmacokinetic profile for ALTO-101 entitles MEDRx to a milestone payment of $1.5 million from Alto.
This announcement is based on a press release statement from Alto Neuroscience, Inc.
InvestingPro Insights
As Alto Neuroscience, Inc. (NYSE: ANRO) progresses with its clinical trials for ALTO-101, the company's financial health and market position are essential for investors to monitor. According to InvestingPro data, ANRO holds a market capitalization of $366.41 million, which provides a sense of the company's size in the biotechnology sector.
Still, the financials reveal a challenging profitability landscape, with an operating loss of $37.81 million over the last twelve months as of Q4 2023 and a return on assets at -52.81% in the same period, indicating the company's current inability to generate profit from its assets.
While the company's stock is trading near its 52-week low, one of the InvestingPro Tips highlights that ANRO's liquid assets exceed its short-term obligations, which could suggest a degree of financial stability in the near term. This is further supported by the fact that ANRO holds more cash than debt on its balance sheet, a reassuring sign for investors concerned about the company's solvency amidst its ongoing research and development efforts.
Nevertheless, potential investors should be aware that ANRO does not pay dividends, which is common for companies prioritizing growth and investment in research over immediate shareholder returns. Moreover, the company has been not profitable over the last twelve months, which is reflected in its negative P/E ratio of -10.07.
These financial metrics and strategic insights into ANRO's operations are available with additional tips on InvestingPro, where users can find a total of 6 tips to further evaluate the company's prospects. To access these insights, users can take advantage of an exclusive offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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