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1246 University Ave West, Suite 404
St.Paul, MN 55104 USA
phone:(516) 303-8181
fax:(516) 706-0027
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ELGO.OB |
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OTC |
| Founded |
0 |
| Employees |
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| www.enterologics.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| making probiotics available as new therapeutic alternatives for inadequately treated GI diseases. |
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| Management |
| Robert Hoerr, M.D., PhD. President, Director and Co-Founder; Lawrence Levitan, M.D. Treasure, Director and Co-Founder; William Welwart. Vice President, Director and Co-Founder |
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| Keywords |
| probiotics, gastroenterology, bacteria, gastrointestinal disease, genomic profiling |
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| Description |
Enterologics was founded in 2009 for the sole purpose of making probiotics available as new therapeutic alternatives for inadequately treated GI diseases. They operate as a virtual team of experts and partner with the best outside biologic production resources they can identify. Their goal is to keep development costs low and make time to market as fast as possible.
Their mission is to bring unique strains of probiotic bacteria to market as FDA-approved “live biotherapeutics” for gastrointestinal diseases.
Our guiding principles:
Minimize development risk. Probiotic strains they acquire will have prior human use and evidence of safety and therapeutic benefits. Enterologics will build a strong scientific portfolio by extensive strain characterization, including state-of-the-art genomic profiling.
Enhance value by following a rigorous product development template. Enterologics develops their probiotic strains as “live biotherapeutics” following FDA guidelines to demonstrate the safety and clinical efficacy of biologic drugs. This builds the scientific underpinnings needed to ensure the highest quality product and unequivocal demonstration of clinical benefit.
Engineer quality and product performance. Selection of the optimal dosage form is important as the right probiotic. They have identified a superior formulation technology called “vitrification” that extends shelf live better than traditional freeze-drying. This new preservation technology, coupled with rigorous production and quality standards, will ensure prescriber confidence that our products deliver viable bacteria at a reproducible and effective dose. |
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| Products / Services |
Enterologics is actively seeking to in?license or acquire probiotic strains that are suitable for development as biologic drugs. Candidates must have the potential for addressing unmet therapeutic needs for gastrointestinal diseases.
They will develop these probiotics as live biotherapeutics (biologic drugs). They will follow a rigorous but
efficient template designed to support FDA approval and to meet the high standards demanded by the medical community. Their strategy is aligned with recent draft guidance from FDA for developing live organisms.
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| Technology / Differentiation |
Enterologics has identified a new, state-of-the-art technology for preserving probiotics so that they can be stored at room temperature without loss of potency. The technology was invented by Universal Stabilization Technologies, Inc. Enterologics has an exclusive option to evaluate and license this technology for use in E. coli probiotics.
Why is this important? It is difficult for consumers to know if probiotic products purchased over-the-counter contain live, active bacteria. Some product labels provide no information about the probiotic strain or number of viable cells per serving or capsule. Others report counts of viable cells at the time of manufacture, not at the time of purchase.
Potency is a critical piece of information, especially since traditional freeze-drying approaches may damage probiotics. They may be particularly vulnerable to temperature, which is why some probiotics are only found in refrigerated cases.
Enterologics' goal is to produce products that can meet the rigorous standards of biologic drugs for potency. Because a stable, viable delivery format is a critical element for medical applications, this new preservation technology is a core element of their development program. |
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