(RTTNews) - Palisade Bio, Inc. (PALI), a clinical-stage biopharmaceutical company, Tuesday reported positive topline data from its Phase 1 studies of PALI-2108, which is being developed for the treatment of fibrostenotic Crohns disease (FSCD) and ulcerative colitis (UC).
The Phase 1 study in adult healthy volunteers, as well as a small cohort of UC patients, met its primary endpoints of safety, tolerability, and pharmacokinetics.
Based on these results, the company plans to start an additional safety and tolerability and PK/PD (pharmacokinetics/pharmacodynamics) exploration Phase 1b cohort in FSCD, in addition to completing long-term chronic safety and toxicology studies. This will be closely followed by initiating Phase 2 studies to evaluate the efficacy, safety, and tolerability of PALI-2108 in patients with FSCD and those with moderate to severe UC. "The observed tissue penetration of the active drug and the absence of serious adverse events, together with our significant body of nonclinical PK data, support our confidence in advancing PALI-2108 into patient-focused trials for fibrostenotic Crohns disease and ulcerative colitis," said Mitchell Jones, Chief Medical Officer of Palisade Bio.
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