CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ: PALI), a biopharmaceutical company, has announced the commencement of a Phase 1 clinical trial for its drug candidate PALI-2108, aimed at treating ulcerative colitis (UC). The first participant has been dosed in a study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the orally administered PDE4 inhibitor prodrug.
The trial is a single-center, double-blind, placebo-controlled study involving healthy volunteers, and will include an open-label segment with UC patients. The study will explore the effects of single and multiple ascending doses of PALI-2108, as well as the impact of food intake on the drug's pharmacokinetics. Patient screening for the trial is currently ongoing.
PALI-2108 is a new chemical entity that has not been previously administered to humans. It is bioactivated in the colon and could potentially offer a novel treatment option for those affected by UC. The study will utilize biomarkers such as serum high sensitivity C-reactive protein and fecal calprotectin, along with colonic tissue histological assessments, to gain insights into the drug's effects.
JD (NASDAQ:JD) Finley, CEO of Palisade Bio, expressed that this marks a significant step for the company as it transitions to a clinical stage. Topline data from the study is expected to be released in the first half of 2025.
The initiation of this clinical trial is part of Palisade Bio's broader efforts to develop therapies for autoimmune, inflammatory, and fibrotic diseases. For additional details on the Phase 1 clinical study, reference identifier NCT06663605 can be found on clinicaltrials.gov.
This announcement contains forward-looking statements regarding the company's clinical development plans and potential market opportunities. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
The information reported is based on a press release statement from Palisade Bio.
In other recent news, Palisade Bio, Inc. is making significant advancements with PALI-2108, a novel treatment for ulcerative colitis. The biopharmaceutical company has received approval from Health Canada to commence a Phase 1 clinical trial for PALI-2108, with the trial set to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers and ulcerative colitis patients. Additionally, Palisade Bio has refined patient selection strategies for PALI-2108 in collaboration with Strand Life Sciences, potentially enhancing the precision of treatment.
In terms of financial developments, analysts from Ladenburg Thalmann have maintained a Buy rating for Palisade Bio. 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.
Further, Palisade Bio has 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.
InvestingPro Insights
As Palisade Bio (NASDAQ: PALI) embarks on its Phase 1 clinical trial for PALI-2108, investors should be aware of several key financial metrics and insights provided by InvestingPro.
The company's market capitalization stands at a modest $3.02 million, reflecting its early-stage status in drug development. This aligns with the article's emphasis on Palisade Bio transitioning to a clinical stage company.
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 process of clinical trials. Additionally, liquid assets exceed short-term obligations, potentially providing some financial flexibility as the company progresses with its PALI-2108 study.
However, investors should note that the company is quickly burning through cash, a common characteristic of pre-revenue biotech firms. This factor may be particularly relevant given the expected timeline for topline data release in the first half of 2025.
It's worth mentioning that InvestingPro offers 13 additional tips for PALI, which could provide further insights into the company's financial health and market position as it advances its clinical program.
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