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NEWS
Palisade Bio Announces Preliminary Data from Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis Appears to be Safe and Well Tolerated in Treated Subjects
Tuesday, 3rd December at 8:15 am
First three Single Ascending Dose cohorts demonstrated no treatment related adverse events
Carlsbad, CA, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (NASDAQ: PALI) ("Palisade," "Palisade Bio" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for PALI-2108 for the treatment of Ulcerative Colitis (UC).
The ongoing Phase 1 study is evaluating PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers, alongside an open-label study involving a patient cohort with UC.
Preliminary results appear to indicate that PALI-2108 was safe and well tolerated in the first three cohorts (n=24; 6:2 active to placebo) at 15mg, 50mg, and 150mg, with no treatment related dose reductions, no Treatment Related Adverse Events (TRAEs), no Serious Adverse Events (SAEs), and no treatment related lab abnormalities in any subject. Preliminary PK data from the first cohorts demonstrated delayed release of the PDE4 inhibitor active suggesting PALI-2108 is performing as designed with colonic bioactivation. Based on the findings with this preliminary safety data, the Company is advancing towards its planned crossover study to evaluate the effects of food on PK, followed by multiple ascending dose (MAD) cohorts, and finally a multiple dose cohort of patients with UC. Comprehensive safety monitoring and similar PK evaluations will be conducted in this cohort.
Tuesday, 3rd December at 8:15 am
First three Single Ascending Dose cohorts demonstrated no treatment related adverse events
Carlsbad, CA, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (NASDAQ: PALI) ("Palisade," "Palisade Bio" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for PALI-2108 for the treatment of Ulcerative Colitis (UC).
The ongoing Phase 1 study is evaluating PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers, alongside an open-label study involving a patient cohort with UC.
Preliminary results appear to indicate that PALI-2108 was safe and well tolerated in the first three cohorts (n=24; 6:2 active to placebo) at 15mg, 50mg, and 150mg, with no treatment related dose reductions, no Treatment Related Adverse Events (TRAEs), no Serious Adverse Events (SAEs), and no treatment related lab abnormalities in any subject. Preliminary PK data from the first cohorts demonstrated delayed release of the PDE4 inhibitor active suggesting PALI-2108 is performing as designed with colonic bioactivation. Based on the findings with this preliminary safety data, the Company is advancing towards its planned crossover study to evaluate the effects of food on PK, followed by multiple ascending dose (MAD) cohorts, and finally a multiple dose cohort of patients with UC. Comprehensive safety monitoring and similar PK evaluations will be conducted in this cohort.
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