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ClostraBio is built and backed by heavyweight ecosystem players in Chicago.
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Our technology was spun out of the Nagler and Hubbell labs at the University of Chicago, and we are members of Portal Innovations, a premier venture development engine focused on early-stage life science enterprises.
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Unmet Need and Solutions
Our co-founder Dr. Cathryn Nagler, a world-leader in researching the microbiome and its relationship to food allergy and other intestinal disorders, has published work demonstrating short-chain fatty acids (SCFAs) derived from commensal bacteria, particularly butyrate, are promising therapeutic candidates because of their critical roles in maintaining epithelial barrier function and inducing gut-resident Tregs. As endogenous gut components they are also generally regarded as safe (GRAS).
However, oral delivery of butyrate to the small intestine and colon has been a challenge because even with enteric coating or encapsulation, it possesses a foul odor and taste, is not absorbed in the part of the gut where it can have a therapeutic effect, and is metabolized too rapidly to maintain a pharmacologic effect.
To date, success with oral butyrate has been limited, and delivery via enema, while effective, is not an acceptable route of administration for daily management of IBD or food allergy. Additionally, harnessing any bacterial metabolite as a therapeutic without modification also creates challenges for patenting and obtaining exclusivity.
ClostraBio has solved these problems using two novel approaches:
Regarding the latter solution, our co-founder Dr. Jeffrey Hubbell has developed polymers that self-assemble into micelles that protect and stabilize butyrate, which is released enzymatically. These polymers, known as CLB-004, have demonstrated controlled, extended release of butyrate in the ileum, cecum and colon in vivo: exactly where commensal bacteria produce butyrate in healthy individuals.
Our co-founder Dr. Cathryn Nagler, a world-leader in researching the microbiome and its relationship to food allergy and other intestinal disorders, has published work demonstrating short-chain fatty acids (SCFAs) derived from commensal bacteria, particularly butyrate, are promising therapeutic candidates because of their critical roles in maintaining epithelial barrier function and inducing gut-resident Tregs. As endogenous gut components they are also generally regarded as safe (GRAS).
However, oral delivery of butyrate to the small intestine and colon has been a challenge because even with enteric coating or encapsulation, it possesses a foul odor and taste, is not absorbed in the part of the gut where it can have a therapeutic effect, and is metabolized too rapidly to maintain a pharmacologic effect.
To date, success with oral butyrate has been limited, and delivery via enema, while effective, is not an acceptable route of administration for daily management of IBD or food allergy. Additionally, harnessing any bacterial metabolite as a therapeutic without modification also creates challenges for patenting and obtaining exclusivity.
ClostraBio has solved these problems using two novel approaches:
- through discovery and development of a butyrate-producing probiotic as a potential dietary supplement, and
- by creating block copolymers that deliver butyrate directly to the lower gut.
Regarding the latter solution, our co-founder Dr. Jeffrey Hubbell has developed polymers that self-assemble into micelles that protect and stabilize butyrate, which is released enzymatically. These polymers, known as CLB-004, have demonstrated controlled, extended release of butyrate in the ileum, cecum and colon in vivo: exactly where commensal bacteria produce butyrate in healthy individuals.
Next-Generation Probiotic Overview
ClostraBio is developing a novel probiotic called CLB-101 as a dietary supplement for various applications related to maintaining and promoting gut health. This next-generation probiotic strain is an anaerobe, a spore-former and known butyrate producer, and was found to be lacking in infants with food allergy. In research studies, when the strain was colonized in cow's milk allergic mice, it was able to prevent an allergic response to food.
ClostraBio is developing a novel probiotic called CLB-101 as a dietary supplement for various applications related to maintaining and promoting gut health. This next-generation probiotic strain is an anaerobe, a spore-former and known butyrate producer, and was found to be lacking in infants with food allergy. In research studies, when the strain was colonized in cow's milk allergic mice, it was able to prevent an allergic response to food.
Butyrate Prodrug Product Development Overview
ClostraBio has completed numerous supportive nonclinical studies to validate our CLB-004 program. The company has transferred our manufacturing process to a CDMO where we've successfully manufactured multiple kg-scale batches of material for nonclinical studies.
With IND-enabling toxicology studies underway, we expect to initiate clinical studies in the near future. Given the expected favorable safety profile of our compounds, we intend to enroll patients with mild-moderate ulcerative colitis (UC) as part of a Phase 1a/b SAD-MAD clinical study to obtain safety/tolerability data, determine our Phase 2 dose, and generate exploratory efficacy endpoints.
ClostraBio is actively seeking further investment to complete IND-enabling activities and conduct the Phase 1a/b clinical study.
ClostraBio has completed numerous supportive nonclinical studies to validate our CLB-004 program. The company has transferred our manufacturing process to a CDMO where we've successfully manufactured multiple kg-scale batches of material for nonclinical studies.
With IND-enabling toxicology studies underway, we expect to initiate clinical studies in the near future. Given the expected favorable safety profile of our compounds, we intend to enroll patients with mild-moderate ulcerative colitis (UC) as part of a Phase 1a/b SAD-MAD clinical study to obtain safety/tolerability data, determine our Phase 2 dose, and generate exploratory efficacy endpoints.
ClostraBio is actively seeking further investment to complete IND-enabling activities and conduct the Phase 1a/b clinical study.
Polymeric Nanoparticle Prodrug Platform
ClostraBio has demonstrated our plug-n-play platform can be utilized to formulate multiple small molecule prodrugs for targeted delivery and sustained release in the lower gut. In addition to CLB-004 polymers, our chemists have synthesized both SCFA and non-SCFA bacterial metabolite polymer nanoparticles that hold promise as potential treatments for various autoimmune, metabolic and neurological indications.
If your drug development team is interested in learning more about our platform and potential collaboration opportunities, please reach out to our business development team via the CONTACT page.
ClostraBio has demonstrated our plug-n-play platform can be utilized to formulate multiple small molecule prodrugs for targeted delivery and sustained release in the lower gut. In addition to CLB-004 polymers, our chemists have synthesized both SCFA and non-SCFA bacterial metabolite polymer nanoparticles that hold promise as potential treatments for various autoimmune, metabolic and neurological indications.
If your drug development team is interested in learning more about our platform and potential collaboration opportunities, please reach out to our business development team via the CONTACT page.
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ClostraBio offers the following:
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A plug-n-play nanoparticle drug delivery platform: with demonstrated delivery of multiple effector molecules including short-chain fatty acids, other bacterial metabolites and small molecules.
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An opportunity to treat the underlying condition(s): modulating barrier function and immune response without suppression of immunity.
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A first-in-class, next-generation probiotic strain backed by strong science with GRAS-affirmation underway.
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A well-rounded team of highly respected scientists, serial entrepreneurs and experienced drug developers.
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A focus on restoration of intestinal barrier-protective function and innate immunity to promote gut health, and directly treat IBD and food allergy.
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