Enterologics to Develop Probiotics as Biologic Drugs for Gastrointestinal Diseases
Product News Apr 20, 2011
Enterologics, Inc. unveiled its business strategy to build and develop a pipeline of probiotic biologics. The Company will license or acquire specific probiotic strains and develop these to meet the exacting standards necessary for FDA approval as prescription biologics for specific gastrointestinal (GI) indications.
Many GI disorders are poorly addressed by current therapies, including pouchitis, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and Clostridium difficile infections.
"Today, most probiotic bacteria are sold over-the-counter as dietary supplements or in food products such as yogurt, with ambiguous benefits. Instead, Enterologics plans to commercialize our probiotic strains as biologics, each meeting FDA standards for clinical efficacy and approval for a specific indication. We believe that this will establish a unique and strong competitive position in the market," stated Bob Hoerr, Co-Founder and President.
"We have identified a series of candidate probiotic strains for potential licensing," Dr. Hoerr continued. "We intend to transform each strain into proprietary, live biotherapeutic products, together with a proprietary formulation process to preserve maximum biologic activity. Each product will follow a rigorous development template that includes comprehensive bacterial strain characterization, genomic sequencing and dosage form optimization. Our goal is to move as quickly as possible into clinical trials under an active Investigational New Drug (IND) application."
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." The community of bacteria living in the gut, which differs in each individual, is the microflora.
Poor eating habits, stress, or antibiotics and other drug treatments for various conditions can disrupt the microflora's natural balance. Disturbances in this equilibrium may occur in conjunction with various GI diseases and may even contribute to their cause.
There are many hurdles to developing probiotics as prescription drugs, including meeting the stringent requirements of the FDA for quality and demonstrated efficacy through clinical testing. However, this pathway does exist and at least one IND has been approved for a specific probiotic bacterial strain.
In their publications, FDA scientists have termed such products "live biotherapeutics," contrasting these to other biologic products, many of which may have been produced by living organisms or cells, but are not in and of themselves capable of replicating and multiplying in the body.
Dr. Hoerr predicted that broader medical use will follow convincing clinical tests of the type used to obtain regulatory approval for drugs and biologics to treat specific conditions. Enterologics will pursue its business plan to develop prescription biologics and drugs for treating various gastrointestinal disorders, subject to the availability of funding.
The Company plans to finance the development of its business from outside sources including through the sale of equity, debt or convertible securities, third party financing and strategic partnering. The goal is to secure sufficient financing to acquire and move a pipeline of products forward in clinical development as efficiently as possible.