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Palisade Bio Announces Successful Completion of First GMP Manufacturing of PALI-2108 Drug Substance and Engineering Batches of Drug Product
Palisade Bio announced the successful completion of the first GMP manufacturing batch of its drug substance PALI-2108, targeted for treating moderate-to-severe ulcerative colitis (UC).
The company partnered with Eurofins for process development and scale-up. The drug substance has been utilized in completed murine and non-murine GLP toxicology studies and will be used in an upcoming Phase 1 clinical study set to start before the end of the year.
Palisade Bio also completed manufacturing and testing of enteric-coated tablets of PALI-2108, ensuring reliable drug release profiles. In a DSS-induced UC mouse model, significant reductions in disease activity index and body weight loss were observed, indicating promising efficacy.
CEO J.D. Finley emphasized the importance of this milestone in advancing effective therapies for UC patients and expressed optimism about the upcoming clinical trial data.
The company partnered with Eurofins for process development and scale-up. The drug substance has been utilized in completed murine and non-murine GLP toxicology studies and will be used in an upcoming Phase 1 clinical study set to start before the end of the year.
Palisade Bio also completed manufacturing and testing of enteric-coated tablets of PALI-2108, ensuring reliable drug release profiles. In a DSS-induced UC mouse model, significant reductions in disease activity index and body weight loss were observed, indicating promising efficacy.
CEO J.D. Finley emphasized the importance of this milestone in advancing effective therapies for UC patients and expressed optimism about the upcoming clinical trial data.
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