PRODUCTS AND RATIONALE

Lead Product

PB-1 is a combination drug product containing eight probiotics and a combination of two antibiotics encapsulated together as one single dose.

• Minimizes secondary infections such as c. difficile due to antibiotic therapy – through the prophylactic addition of probiotics

• Will maintain homeostasis within the Gut Microbiome

• Will enhance patient ease of convenience and compliance in taking multiple medications

Additional anticipated applications exist for PB-1’s use in pediatric IBD, pulmonary, urology, infectious diseases, and veterinary medicine in modified doses.

In contrast to most antibiotics that dissolve in the stomach with negative side effects, PB-1 is a pH-dependent antibiotic/probiotic dual release capsule targeted for optimal delivery to the areas of highest need.

Combination capsule allows for an immediate release of probiotics in the stomach combined with pH-dependent release of antibiotics in the area of the terminal ileum.

Competitive Advantage

There is no known pharmaceutical cure for IBD and current treatment options are limited to controlling symptoms, maintaining remission and preventing relapse.  In contrast, PARABIOTIC anticipates a more curative potential – defined as remission of at least five years. There is no other drug product on the market today for IBD that combines the advantages of PB-1 – that are both therapeutic and prophylactic combined together in one single dose. Once PB-1 is developed PARABIOTIC will be in a targeted business franchise and will add to an existing pipeline of a pharma partner a new class of combination antibiotic/probiotic drugs.

PARABIOTIC is a shovel-ready project with development partners identified in the areas of formulation, regulatory and clinical development programs.  PB-1 represents a game changing paradigm for treatment in IBD and infectious diseases.

The company’s unique lead product is the first of a new class of combination antibiotic-probiotic drugs intended to rebalance the microbial gut and mitigate pathogenic inflammatory triggers.

• PB-1 may mitigate the effects of chronic inflammation often implicated as a causal pathway in the development of colorectal cancer.

• Single dose combination drug product will address patient ease of convenience/compliance in taking multiple medications as opposed to taking multiple single pills.

• Cost effective; may reduce the need for hospitalizations and surgery.

• PB-1 is designed to address causal factors of disease as opposed to most treatment options that are merely symptom managing.

• PB-1’s antibiotics are “older” drugs not indicated for IBD and less likely to have patient-resistant genes due to prior multiple exposures.

Additional Patent Applications Filed

PB-2 is a combination drug product consisting of two widely prescribed antibiotics and a proprietary blend of probiotics for the treatment of infectious diseases.

PB-3 is a combination drug product designed to treat the symptoms of travelers’ diarrhea and irritable bowel syndrome (IBS).

Rationale

80% of the body’s immune system resides in the intestines. If the gut microbiome is not healthy, the rest of the body is not far behind.

The cause of IBD appears to involve complex interactions of genetic predisposition, environmental factors, disruption of the intestinal microbiome, and an overly aggressive immune response. There is mounting evidence that these factors are implicated in the pathogenesis of IBD. As yet, questions remain whether commensal enteric bacteria or invasive strains of pathogenic bacteria, particularly e. coli, are a direct trigger cause in IBD. The suspicion is they both may be contributing factors in different subsets of patients. Both Crohn’s disease and ulcerative colitis primarily affect intestinal areas with the highest bacterial counts.

Empirical evidence implicating a role for intestinal flora is that treatment with antibiotics and probiotics was found to be beneficial and is now utilized for induction and maintenance of remission. Imbalances of “friendly bacteria” in the gut microbiome destroyed by antibiotics as well as opportunistic pathogens are implicating factors in the disease process.

In our view, an integrated approach to healing must be considered as part of an effective protocol along with appropriate medical treatment. This integrated approach consisting of medical, dietary and probiotics appears to be a new direction for combating disease.

There is increasing evidence that bacteria are involved in the pathogenesis of IBD. Current thinking by many key opinion leaders now suggests that IBD is considered an infectious disease initiated by pathogenic or mutated commensal bacteria as opposed to a previously classified autoimmune disease. If this new thinking is correct, this holds great promise for Parabiotic’s approach to treatment with PB-1 and its Methods for Treatment.

Modification of the gut bacterial flora by targeted antibiotics and probiotics may be effective in treating ulcerative colitis and Crohn’s disease.  An altered gut microbiota plays an important role in the pathogenesis of IBD, particularly Crohn’s disease. In addition, adherent invasive e. coli (AIEC) strains are identified with increased frequency in patients with ileal Crohn’s disease compared with healthy individuals. Convincing data from both animal models and the study of patients with ulcerative colitis implicates the intestinal microflora in the initiation and maintenance of the inflammatory process in IBD.