Enterologics, Inc., (OTCBB: ELGO.OB) a biotechnology company, is dedicated to the development of live biotherapeutic products for gastrointestinal (GI) disorders that it believes are poorly addressed by current therapies. Key examples include pouchitis, irritable bowel syndrome (IBS), Crohn’s disease, ulcerative colitis and Clostridium difficile infections.
Enterologics intends to license or acquire technology to build a product pipeline based on producing probiotic bacteria in novel, shelf-stable, high potency formulations that are delivered orally. Unlike probiotic bacteria that are sold over-the-counter as dietary supplements or in food products such as yogurt, we intend to develop products to meet the exacting standards necessary to gain FDA approval as prescription drugs and biologics, with demonstrated safety and clinical benefits for specific GI indications.
Probiotics are live microorganisms (in most cases, bacteria) that are similar to or derived from beneficial microorganisms found in the human gut. They are also called “friendly bacteria” or “good bacteria.” Probiotics are available in foods such as yogurt and as dietary supplements (for example, capsules, tablets, and powders). Brand names that imply wellness or regularity in bowel function, coupled with ambiguous marketing claims to promote health, create interest but also confusion for consumers and physicians as to the real benefit of the specific product.
Enterologics believes that broader medical use of probiotics will follow convincing clinical tests of the type used to obtain regulatory approval for drugs and biologics to treat specific conditions. The Company intends to identify, in-license and develop unique probiotic strains for specific medical conditions, obtain regulatory approval and market these probiotics products as FDA-approved prescription drugs for specific label indications. Predictable product potency is a critical feature of a live biotherapeutic. Subject to UST’s technology meeting the Company’s specifications and our funding resources, we intend to license UST’s bacterial vitrification process, which we believe is far superior to other drying techniques and which we believe will enable us to meet the high potency standards necessary for prescription drug approval. This technology will be used to create highly stable dosage forms of our probiotic candidate products.
Enterologics will pursue its business plan to develop prescription biologics and drugs for treating various gastrointestinal disorders,subject to the availability of funding. We intend to finance the development of our business, including our prescription drug development efforts, from outside sources including through the sale of equity, debt or convertible securities, third party financing and strategic partnering. Our goal is secure sufficient financing to acquire and move a pipeline of products forward in clinical development as efficiently as possible.