Copied below is a section from the link listed on
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Posted On: 10/04/2017 8:19:11 PM
Copied below is a section from the link listed on the IPIX website under the blog section:
What I found interesting, and was new to me, is as follows. These comments are my take and may be in error. If anyone with a medical background sees that I interpreted anything incorrectly, please respond with corrections as they will be most appreciated:
Brilacidin is not a "small" molecule but has a robust structure, unlike peptidic-based small molecules, and thus is not subject to most of the traditional shortcomings of peptidic-based small molecules to include rapid proteolytic degradation which I think means the body doesn't flush it out that quickly (unlike Kevetrin which has a very short life) and thus it makes oral delivery formulation more challenging. Note that they say it is not impossible, just more challenging. They later in the article say that a pill formulation for Ucerative Colitis and Crohn's Disease (plus I assume any other problem being addressed in the GI tract) is in the company formulation development plans so I take that to mean it will get done. They also state that the systemic buildup of B during treatment is something that the doctors will have to watch. Topical treatment is preferred such as the gel for UPS and the mouthwash for OM. Because B is such a strong killer of all bacteria, both good and bad, this could become the factor that is most watched as to safety for the use of B in any specific application. Thus, there are areas of safety that must be addressed w/ B. I point this out as I had thought B was totally safe (along w/ P and K) but now realize there are some issues that have to be closely watched and some applications may not be right for B not because of the bad stuff it kills but because of the possible good stuff it could kill. I am sure medical/well read posters already knew this, but for the low hanging fruit like me it might help them get a better grasp on B. I am making this post since the company felt it important enough to post on the Blog section of their website in Sept.
September 11, 2017 EVERYTHING BELOW FROM CO. WEBSITE
Brilacidin Formulation Work
Brilacidin
Brilacidin, computationally designed as a biomimetic polymer with a robust structure, and unlike peptidic-based small molecules, is not subject to most of the traditional shortcomings of antimicrobial peptide (AMP)-based therapeutics, including rapid proteolytic degradation. This can make drug formulation work, particularly the oral delivery (pdf) of medications, more challenging (e.g., see the FORMAMP Project).
Brilacidin already has been shown to have a favorable safety profile and has met efficacy endpoints when administered systemically, via intravenous (IV) dosing, in a Phase 2b trial in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), as well as when topically-applied -- as shown in Phase 2 trials in Ulcerative Proctitis / Ulcerative Proctosigmoiditis (UP/UPS) (administered in water as a retention enema) and in Oral Mucositis (OM) (given as a "swish and spit"
.
Future Brilacidin formulation development plans include foam and/or gel for the treatment of UP/UPS, and pills for the oral dosing of Ulcerative Colitis and Crohn’s Disease.
Physicians typically prefer topical therapies, over systemic ones, as they have safer profiles, are more conveniently administered ("patient-friendly" , and help ensure better compliance to treatments.
"While efficacy and safety often had greater relative importance than treatment process, treatment process also had a quantifiable impact on preference. In some instances, particularly in diabetes and autoimmune disorders, treatment process attributes had greater relative importance than some or all efficacy and safety attributes." (Source: "Preference for Pharmaceutical Formulation and Treatment Process Attributes." Patient Prefer Adherence. 2016; 10: 1385–1399.)
http://www.ipharminc.com/new-blog/
What I found interesting, and was new to me, is as follows. These comments are my take and may be in error. If anyone with a medical background sees that I interpreted anything incorrectly, please respond with corrections as they will be most appreciated:
Brilacidin is not a "small" molecule but has a robust structure, unlike peptidic-based small molecules, and thus is not subject to most of the traditional shortcomings of peptidic-based small molecules to include rapid proteolytic degradation which I think means the body doesn't flush it out that quickly (unlike Kevetrin which has a very short life) and thus it makes oral delivery formulation more challenging. Note that they say it is not impossible, just more challenging. They later in the article say that a pill formulation for Ucerative Colitis and Crohn's Disease (plus I assume any other problem being addressed in the GI tract) is in the company formulation development plans so I take that to mean it will get done. They also state that the systemic buildup of B during treatment is something that the doctors will have to watch. Topical treatment is preferred such as the gel for UPS and the mouthwash for OM. Because B is such a strong killer of all bacteria, both good and bad, this could become the factor that is most watched as to safety for the use of B in any specific application. Thus, there are areas of safety that must be addressed w/ B. I point this out as I had thought B was totally safe (along w/ P and K) but now realize there are some issues that have to be closely watched and some applications may not be right for B not because of the bad stuff it kills but because of the possible good stuff it could kill. I am sure medical/well read posters already knew this, but for the low hanging fruit like me it might help them get a better grasp on B. I am making this post since the company felt it important enough to post on the Blog section of their website in Sept.
September 11, 2017 EVERYTHING BELOW FROM CO. WEBSITE
Brilacidin Formulation Work
Brilacidin
Brilacidin, computationally designed as a biomimetic polymer with a robust structure, and unlike peptidic-based small molecules, is not subject to most of the traditional shortcomings of antimicrobial peptide (AMP)-based therapeutics, including rapid proteolytic degradation. This can make drug formulation work, particularly the oral delivery (pdf) of medications, more challenging (e.g., see the FORMAMP Project).
Brilacidin already has been shown to have a favorable safety profile and has met efficacy endpoints when administered systemically, via intravenous (IV) dosing, in a Phase 2b trial in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), as well as when topically-applied -- as shown in Phase 2 trials in Ulcerative Proctitis / Ulcerative Proctosigmoiditis (UP/UPS) (administered in water as a retention enema) and in Oral Mucositis (OM) (given as a "swish and spit"
. Future Brilacidin formulation development plans include foam and/or gel for the treatment of UP/UPS, and pills for the oral dosing of Ulcerative Colitis and Crohn’s Disease.
Physicians typically prefer topical therapies, over systemic ones, as they have safer profiles, are more conveniently administered ("patient-friendly"
, and help ensure better compliance to treatments. "While efficacy and safety often had greater relative importance than treatment process, treatment process also had a quantifiable impact on preference. In some instances, particularly in diabetes and autoimmune disorders, treatment process attributes had greater relative importance than some or all efficacy and safety attributes." (Source: "Preference for Pharmaceutical Formulation and Treatment Process Attributes." Patient Prefer Adherence. 2016; 10: 1385–1399.)
http://www.ipharminc.com/new-blog/
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