CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a biopharmaceutical company, has announced the receipt of a No Objection Letter from Health Canada for its Phase 1 clinical trial of PALI-2108, a drug candidate for the treatment of ulcerative colitis (UC). The company is set to begin the study before the end of the year, marking a significant milestone in the development of PALI-2108.
The planned trial is a single-center, double-blind, placebo-controlled study that will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in healthy volunteers and an open-label study with a patient cohort suffering from UC. Approximately 90 patients are expected to be enrolled across various cohorts, assessing the effects of single and multiple doses, as well as the impact of food on the drug's pharmacokinetics.
Current treatments for UC, a chronic inflammatory bowel disease, often fall short of inducing complete remission, with less than a quarter of patients achieving this outcome. The most effective therapies can require injections or carry significant side effects, highlighted by black box warnings. PALI-2108 is a PDE4 inhibitor prodrug designed to be locally bioactivated in the colon, offering a potentially safer and more effective oral medication option for UC patients.
The primary objective of the upcoming study is to assess the safety and tolerability of PALI-2108, with secondary objectives including determining the drug's pharmacokinetics and its metabolites in plasma, urine, and feces. Exploratory objectives will focus on pharmacodynamic biomarkers and other indicators of the drug's effect on UC.
Palisade Bio's efforts to develop novel therapeutics target autoimmune, inflammatory, and fibrotic diseases with the aim of transforming treatment landscapes. The company's progress with PALI-2108 comes as the global UC market is projected to grow to nearly $10 billion by 2028.
This announcement is based on a press release statement from Palisade Bio, which contains forward-looking statements regarding the development and potential of PALI-2108. These statements reflect the company's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
In other recent news, Palisade Bio, Inc. has made several noteworthy strides in its operations. The biopharmaceutical company has updated its employment agreement with CEO J.D. Finley, outlining potential severance benefits and conditions for stock option grants. The company has also advanced its ulcerative colitis treatment, PALI-2108, by refining patient selection strategies in collaboration with Strand Life Sciences.
Palisade Bio is set to initiate a Phase 1 human clinical trial for PALI-2108 and has secured a European patent for its innovative therapeutics targeting inflammatory bowel diseases. Moreover, the company has successfully manufactured the first GMP batch of PALI-2108, demonstrating readiness for upcoming trials.
In terms of financial developments, Ladenburg Thalmann analysts have maintained a Buy rating for Palisade Bio. Furthermore, the company's shareholders recently elected three directors and ratified the appointment of Baker Tilly US, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024. These are among the recent developments within the company.
InvestingPro Insights
As Palisade Bio (NASDAQ:PALI) prepares to launch its Phase 1 clinical trial for PALI-2108, investors should consider some key financial metrics and insights provided by InvestingPro. The company's market capitalization stands at a modest $3.99 million, reflecting its early-stage status in drug development.
InvestingPro Tips highlight that Palisade Bio holds more cash than debt on its balance sheet, which is crucial for a biopharmaceutical company in the resource-intensive phase of clinical trials. This financial cushion could provide some runway as the company advances its ulcerative colitis treatment.
However, it's important to note that Palisade Bio is quickly burning through cash, a common characteristic of pre-revenue biotech firms. The company's Return on Assets is deeply negative at -90.97%, underscoring the significant investments being made in research and development without immediate revenue generation.
The stock price has seen a substantial decline, with a year-to-date total return of -61.92% as of the latest data. This performance aligns with the InvestingPro Tip indicating that the stock is trading near its 52-week low, which may interest value investors but also signals market skepticism.
Despite these challenges, analysts anticipate sales growth in the current year, which could be linked to the potential progress of PALI-2108 and other pipeline candidates. However, it's worth noting that analysts do not expect the company to be profitable this year, a common situation for early-stage biotech firms focused on drug development.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Palisade Bio, providing a deeper understanding of the company's financial health and market position as it embarks on this critical phase of clinical development.
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