CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ: PALI), a biopharmaceutical company, has announced progress on its lead drug candidate, PALI-2108, which is being developed for the treatment of Ulcerative Colitis (UC).
The company is on track to begin Phase 1 clinical trials before the end of the year, following extensive preclinical studies to determine the appropriate starting dose.
PALI-2108 is an orally administered prodrug that specifically targets the colon and acts as a PDE4 inhibitor. The company has employed various scaling methods to establish the Maximum Recommended Starting Dose (MRSD) for human trials.
These methods included integrating data from both intravenous and oral administrations of the drug across multiple species. The data obtained is believed to provide a safe and scientifically grounded starting point for the planned clinical studies.
Dr. Mitch Jones, CMO of Palisade Bio, expressed satisfaction with the progress and anticipation for the upcoming trial. The preclinical phase included pharmacodynamic studies in mice and pharmacokinetic studies across several species, including mice, rats, dogs, and monkeys. Additionally, in vitro experiments were conducted to profile the drug's metabolism and pharmacokinetics characteristics.
The simulations conducted for PALI-2108 suggested dosing regimens that are safe and align with the doses that showed maximal efficacy in animal models. A robust human pharmacokinetic model has been constructed to predict human exposure, incorporating both the PK of PALI-2108 and its active metabolite, PALI-0008.
The Phase 1 clinical trial will evaluate the safety, tolerability, and pharmacokinetics of PALI-2108 in healthy volunteers and UC patients, as well as pharmacodynamics in UC patients. Continuous monitoring will inform future dose escalation and therapeutic strategies.
Palisade Bio focuses on developing therapeutics for autoimmune, inflammatory, and fibrotic diseases, aiming to transform treatment landscapes with targeted approaches.
The company's progress and strategies are based on a press release statement and reflect forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially.
InvestingPro Insights
Amidst the anticipation of Palisade Bio's upcoming clinical trials for its lead drug candidate, PALI-2108, the company's financial health and market performance provide a broader context for investors. According to InvestingPro data, Palisade Bio holds a modest market capitalization of $3.39 million. The company's price-to-book ratio as of Q1 2024 stands at 0.34, potentially indicating that the stock is undervalued compared to its book value. However, this metric should be considered in the context of the company's significant revenue decline over the last twelve months, marked by a 100% decrease.
InvestingPro Tips highlight a mix of challenges and potential for Palisade Bio. Two essential points to note are that the company currently holds more cash than debt on its balance sheet, which may provide some financial stability, and analysts anticipate sales growth in the current year. These insights could be particularly relevant for investors considering the company's need for additional financing and the costs associated with the regulatory approval process for PALI-2108.
Yet, the company's stock performance reflects investor sentiment, with a price total return of -87.56% over the last year. Additionally, the company does not pay dividends, which may influence the investment decisions of income-focused shareholders. For a more comprehensive analysis, there are over ten additional InvestingPro Tips available for Palisade Bio, offering deeper insights into the company's financials and market performance.
As Palisade Bio moves forward with its clinical trials, investors may want to keep an eye on these financial metrics and InvestingPro Tips to gauge the company's potential for growth against the backdrop of its current market position. For those seeking further guidance, additional tips can be explored through the InvestingPro platform.
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