Pete I recently reviewed this issue. I can find no
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Posted On: 07/14/2019 3:41:49 PM
Pete I recently reviewed this issue. I can find no evidence of a drug using BDD technology having been approved.
. The May 2018 agreement with Novartis for its product was its first licensing agreement. The product was not identified and neither Novartis or BDD has issued an update on its development as far as I can determine.
https://www.prnewswire.com/news-releases/bdd-...44281.html
Cingulate has signed a licensing agreement with BDD for
dexmethylphenidate hydrochloride , its hyperactivity drug.
https://btbcku.com/cingulate-therapeutics-ini...cal-trial/
The Cingulate drug was studied in a proof of concept study by BDD at its Glasgow facilities.
"The completion of the agreement follows a successful clinical proof of concept study performed at BDD's facilities in Glasgow, UK which demonstrated that Cingulate's therapy CTx-1301, utilizing OralogiK™ technology, delivered consistent tri-modal release of the dexmethylphenidate hydrochloride (d-MPH), and extended d-MPH blood plasma levels when compared to Focalin® XR's bi-phasic release of d-MPH."
https://www.prnewswire.com/news-releases/bdd-...04650.html
IMO BDD could be working on a similar Proof of Concept for drug delivery study demonstrating Brilacidin levels in the small intestine,colon and distal colon.
Drug delivery in those areas would target Crohn's disease which frequently affects the small intestine, Ulcerative Colitis and Irritable Bowel Syndrome which affects the entire colon and Ulcerative Proctitis which affects the distal colon.
Delivering Brilacilin, a Human defense protein mimetic, to the colon and small intestine would further study the theory that inflammatory bowel disease is at least partially related to diminished Paneth and epithelial cell secretion of human defensin proteins to the gastrointestinal tract.
The stage 2 Brilacidin study for Ulcerative Proctitis showed Brilacidn as a HDP was successful in treating this form of IBD.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204685/
IMO this determination would help IPIX and their potential term sheet partner plan the upcoming FDA studies and could lead to the FDA approving accelerated development.
GLTA Farrell
. The May 2018 agreement with Novartis for its product was its first licensing agreement. The product was not identified and neither Novartis or BDD has issued an update on its development as far as I can determine.
https://www.prnewswire.com/news-releases/bdd-...44281.html
Cingulate has signed a licensing agreement with BDD for
dexmethylphenidate hydrochloride , its hyperactivity drug.
https://btbcku.com/cingulate-therapeutics-ini...cal-trial/
The Cingulate drug was studied in a proof of concept study by BDD at its Glasgow facilities.
"The completion of the agreement follows a successful clinical proof of concept study performed at BDD's facilities in Glasgow, UK which demonstrated that Cingulate's therapy CTx-1301, utilizing OralogiK™ technology, delivered consistent tri-modal release of the dexmethylphenidate hydrochloride (d-MPH), and extended d-MPH blood plasma levels when compared to Focalin® XR's bi-phasic release of d-MPH."
https://www.prnewswire.com/news-releases/bdd-...04650.html
IMO BDD could be working on a similar Proof of Concept for drug delivery study demonstrating Brilacidin levels in the small intestine,colon and distal colon.
Drug delivery in those areas would target Crohn's disease which frequently affects the small intestine, Ulcerative Colitis and Irritable Bowel Syndrome which affects the entire colon and Ulcerative Proctitis which affects the distal colon.
Delivering Brilacilin, a Human defense protein mimetic, to the colon and small intestine would further study the theory that inflammatory bowel disease is at least partially related to diminished Paneth and epithelial cell secretion of human defensin proteins to the gastrointestinal tract.
The stage 2 Brilacidin study for Ulcerative Proctitis showed Brilacidn as a HDP was successful in treating this form of IBD.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4204685/
IMO this determination would help IPIX and their potential term sheet partner plan the upcoming FDA studies and could lead to the FDA approving accelerated development.
GLTA Farrell
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