CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ: PALI), a clinical-stage biopharmaceutical company with a market capitalization of $2.34 million, announced today the completion of the Single Ascending Dose (SAD) stage of its Phase 1a/b study of PALI-2108, a drug candidate for the treatment of Ulcerative Colitis (UC). According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, though investors should note the stock has declined over 78% in the past year. The preliminary data from the SAD cohorts, which ranged from 15 mg to 450 mg doses, indicated that PALI-2108 was well-tolerated at all levels, with no serious adverse events or laboratory abnormalities reported.
The study, which is a single-center trial, aims to assess the safety, tolerability, and pharmacokinetics (PK) of PALI-2108. Preliminary PK analysis suggests the drug has delayed-release and extended-release characteristics, providing sustained drug exposure with high local concentrations in the colon. While InvestingPro data shows the company maintains a healthy current ratio of 3.31 and holds more cash than debt, it's worth noting the company is rapidly burning through its cash reserves. This is considered essential for effectively targeting UC treatment.
Dr. Mitch Jones, Chief Medical (TASE:PMCN) Officer of Palisade, expressed optimism as the study progresses from the SAD to the Multiple Ascending Dose (MAD) cohorts, which will evaluate repeated dosing and further safety and PK in both healthy volunteers and UC patients. The company expects to report topline data in the first half of 2025.
PALI-2108, a new chemical entity and part of a class of PDE4 inhibitors, has shown promise in this early phase of clinical development. Biomarkers and histological assessments of colonic tissue are being used to gain insights into the drug’s effects and mechanism of action.
The advancement of PALI-2108 into the next trial phase reflects Palisade Bio's commitment to developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases. The company's approach focuses on targeted treatments with the aim of transforming the treatment landscape for patients with these conditions. With analyst price targets ranging from $8 to $45 and the next earnings report scheduled for March 27, 2025, investors seeking deeper insights can access 12 additional ProTips and comprehensive financial metrics through InvestingPro.
This press release statement serves as the basis for the reported information, and it is essential to note that the development of PALI-2108 is still in the early stages and subject to further research and regulatory approval processes.
In other recent news, Palisade Bio, Inc. has initiated a Phase 1 clinical trial for its novel drug candidate, PALI-2108, aimed at treating ulcerative colitis. The trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers and ulcerative colitis patients. On the financial front, analysts from Ladenburg Thalmann have maintained a Buy rating for Palisade Bio. In addition, the company's shareholders have recently elected three directors and ratified the appointment of Baker Tilly US, LLP as the independent registered public accounting firm. Palisade Bio has also updated its employment agreement with CEO J.D. Finley, outlining potential severance benefits and conditions for stock option grants. These are among the recent developments within the company. Furthermore, Palisade Bio has presented promising data regarding PALI-2108 at the American College of Gastroenterology's Annual Scientific Meeting, suggesting potential advantages over existing treatments for ulcerative colitis. The company's progress with PALI-2108 represents a step towards addressing the unmet needs in IBD treatment.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.