Palisade Bio Advances UC Drug PALI-2108 to Next Phase

Palisade Bio Expands Clinical Trials for PALI-2108

Palisade Bio, Inc. (NASDAQ: PALI) is making significant strides in its clinical development of PALI-2108, a groundbreaking drug candidate designed to treat Ulcerative Colitis (UC). This clinical-stage biopharmaceutical company recently completed the Single Ascending Dose (SAD) phase of its Phase 1a/b study. The preliminary results are encouraging, suggesting well-tolerated doses from 15 mg up to 450 mg, with no serious adverse events or laboratory abnormalities reported.

Understanding the Drug’s Features

The primary focus of this single-center trial is to evaluate the drug’s safety, tolerability, and pharmacokinetics (PK). Initial analysis indicates that PALI-2108 exhibits both delayed-release and extended-release properties, meaning it offers sustained drug exposure with heightened concentrations in the colon. Such characteristics are critical when targeting UC treatment, potentially leading to improved patient outcomes.

Insights from the Study

Dr. Mitch Jones, the Chief Medical Officer at Palisade, shared insights into the optimism surrounding the transition from SAD to the Multiple Ascending Dose (MAD) cohorts. This next phase will involve repeated dosing and additional evaluations of safety and PK among both healthy participants and those suffering from UC. Results from this phase are expected to be shared in the first half of the following year, marking an important milestone in the drug’s journey.

Promising Drug Development

PALI-2108 belongs to a new class of PDE4 inhibitors and has shown great potential during these early clinical stages. The use of biomarkers and histological assessments of colonic tissue will provide a deeper understanding of the drug's effects and its mechanism of action. These advancements underscore Palisade Bio's dedication to delivering innovative therapeutics for autoimmune, inflammatory, and fibrotic diseases.

Market Position and Future Outlook

The company's unwavering focus on developing targeted treatments aims to transform therapeutic strategies for patients afflicted by these challenging conditions. Analysts have set price targets for PALI ranging from $8 to $45, suggesting that there is optimism around the company's future performance. Moreover, with the upcoming earnings report on the horizon, many investors are eager for clues on long-term potential and company health.

Recent Company Developments

In addition to progressing with PALI-2108, Palisade Bio has undertaken other significant initiatives. A Phase 1 clinical trial has commenced to further assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug among healthy volunteers and UC patients. Financially, Ladenburg Thalmann analysts have reaffirmed a Buy rating for the company, indicating strong confidence in its future.

Additionally, the company has recently elected three new directors and confirmed the appointment of Baker Tilly US, LLP as its independent registered public accounting firm. CEO J.D. Finley’s updated employment agreement includes specific severance benefits alongside stipulations for stock options, reflecting the company's commitment to its leadership team.

Furthermore, Palisade Bio has presented compelling data on PALI-2108 at notable scientific meetings, highlighting its possible advantages compared to existing therapies for UC. As the company continues to advance, the progress made with PALI-2108 represents an essential step towards addressing the unmet needs in the field of inflammatory bowel disease (IBD) treatment.

Frequently Asked Questions

What is PALI-2108?

PALI-2108 is a drug candidate developed by Palisade Bio, targeted for the treatment of Ulcerative Colitis.

What were the results of the recent clinical trial?

The recent trial results indicated that PALI-2108 was well-tolerated across different doses, with no serious adverse events reported.

What is the significance of the Phase 1a/b study?

This Phase 1a/b study is designed to evaluate the drug’s safety, tolerability, and pharmacokinetics, which are crucial for determining its potential effectiveness in treating patients.

How does PALI-2108 aim to help patients?

Its unique delayed-release and extended-release properties may provide sustained exposure and higher drug concentrations locally in the colon, which is essential for targeting UC.

What are the next steps for Palisade Bio?

The company will transition to the Multiple Ascending Dose cohorts and is expected to release topline data in the first half of the next year, further advancing the clinical development of PALI-2108.

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