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Tuesday, November 09, 2021 4:36:54 PM
IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD.
Development of a delayed release oral formulation has been in progress, with development work expanding into immediate release formulations due to unexpected findings encountered. Such findings appear due to the inherent physiochemical properties of the compound, and those of polymers used to achieve delayed release. An immediate release, multi-particulate capsule formulation has been developed and a ‘research and development’ batch has progressed to stability testing at the manufacturing vendor. Further work is ongoing, in preparation for manufacture of clinical trial supplies.
Based on these recent findings, the development plan for ulcerative colitis has been adapted with inclusion of Phase 1 testing of the immediate release oral formulation. Clinical trials will be able to progress pending completion of clinical trial supply manufacturing (currently scheduled for January 2022) and securing sufficient working capital.
Not sure what to make of the apparent difficulty with delayed release oral formulation. I thought we already saw those results with those nice colon images a few years ago? Why now going to immediate release formulation?
https://www.globenewswire.com/news-release/2020/02/13/1984671/0/en/Innovation-Pharmaceuticals-Phase-1-Trial-of-Brilacidin-for-Ulcerative-Colitis-Meets-Primary-Endpoints-Positive-Topline-Results-of-Oral-Brilacidin.html
A little confusing what immediate release will mean - does that mean brilacidin is released in the stomach and small intestine, and not in the large intestine and colon? Why?
Also, do we have enough working capital for the IBD-brilacidin pill trial?
Not happy to see these changes / apparent delayed release formulation difficulties, when the delayed release oral formulation appeared to be solved - as reported by Phase I results in February 2020.
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