Company
Based in Mountain View, CA, Osel Inc. (“Osel” or the “Company”) is a biopharmaceutical company with a proprietary technology platform to develop next-generation probiotics as pharmaceutical products to address major gastrointestinal (“GI”), infectious diseases and women’s health indications. Probiotics are widely used in Europe and Asia, and are rapidly gaining acceptance in the US. The global probiotics market is estimated to reach US $31.2 billion in 2014 with a CAGR of 11.7% from 2009 to 2014.
Elevating probiotics to pharmaceutical products targeting specific medical indications represents a novel opportunity with even larger market potential. Importantly, this approach is grounded in a strong scientific basis. Mucous membranes of humans are densely populated with bacteria, which play an important role in host defense against pathogenic organisms and health. Disruption of this natural microflora is associated with multiple infections & diseases. Osel is the first company to pursue rigorous scientific, clinical and Food and Drug Administration (“FDA”) sanctioned development of naturally occurring and engineered probiotics to prevent and treat major diseases by restoring and enhancing the natural microflora. Osel has extensive patent protection regarding its use of probiotics in pharmaceuticals, particularly surrounding the genus Lactobacillus.
The Company has two lead products in clinical development, LACTIN-V and CBM588, targeting three indications – two major female infections: recurrent urinary tract infection (“RUTI”) and bacterial vaginosis (“BV”); and a major GI infection: Clostridium difficile (“C. diff”) infection (“CDI”). These indications represent major unmet medical needs, each with substantial market potential of over $1 billion worldwide. Promising efficacy data have been generated in recently completed Phase IIa clinical trials which validate the science.
In addition, a third generation engineered probiotic product, MucoCept, is in pre-clinical development and nearing an Investigational New Drug (IND) submission as a novel microbicide for the prevention of HIV infection in women.
Unmet Medical Needs
Diseases Of The Female Urogenital Tract:
The healthy female urogenital tract is densely populated with commensal bacteria, primarily certain Lactobacillus species, that play an important role in protecting the host from infection. Disruption of the Lactobacillus-dominated microbial flora can lead to abnormal vaginal microbial communities associated with bacterial vaginosis (BV), and an increased incidence of urinary tract infection (UTI). In addition, epidemiological studies suggest that the normal vaginal microbial ecosystem may play a critical role in reducing the risk of sexually transmitted infections, including human immunodeficiency virus type 1 (HIV-1). These observations have provided the rationale for using appropriate Lactobacillus species to reduce the risk of infection by preserving or restoring the normal vaginal microflora. Our lead candidate product, LACTIN-V, contains the lactic acid and hydrogen peroxide producing bacterium Lactobacillus crispatus, a naturally occurring member of the protective urogenital microflora.
UTIs account for almost 11 million physician visits each year in the US, and an equal number in Europe. Up to 33% of women with UTIs develop recurrent infections (>2 per year). While a routine UTI is easily treated with a short course of oral antibiotics, treatment of recurrent UTI (RUTI) with multiple courses of antibiotics may lead to resistant strains, diarrhea, and vaginal yeast infections. Thus, there is significant interest amongst women who suffer from RUTI for novel non-antibiotic therapies. Bacterial vaginosis (BV) afflicts over 16 million women every year worldwide, with 50% experiencing recurrent infections, and is the most common reason that women seek medical help, after vaginal yeast infections. It is expected that this product will treat and prevent recurrences of both UTI and BV. Finally, in vitro fertilization (IVF) remains a challenging problem with successful embryo transplantation occurring in only 30% of IVF procedures. Osel’s lead product, LACTIN-V, offers the potential to prevent recurrences of both UTI and BV and to markedly improve the success rate of embryo implants in women undergoing IVF procedures.
Diseases of the Gastrointestinal Tract:
The microflora of the lower bowel is very complex, comprising hundreds of species of bacteria that contribute importantly to fermentative processes and homeostasis of the colon and provide resistance to colonization by potentially pathogenic microorganisms. Disruption of this complex ecosystem, commonly by antibiotics, can weaken colonization resistance and lead to the emergence and overgrowth of enteric pathogens, most notably Clostridium difficile. Clostridium difficile infection (CDI) is the most common intestinal infection in the hospital setting, accounting for over 300,000 cases per year and responsible for more deaths than all other gastrointestinal infections combined. Metronidazole is currently the drug of choice for the initial treatment of CDI, with vancomycin reserved for more serious cases. Although treatment response rates of >90% have been reported for these drugs, CDI relapse is common (15-30%) and represents an unmet medical need. Osel believes the use of antibiotics alone does not fully address the pathophysiology of CDI, which is reflected by high recurrence rates due in part to continued disruption of the colonic microflora. There is a need for a novel adjunct treatment that helps restore the GI microflora, which is the basis of Osel’s probiotic therapy.
Osel is developing a novel GI probiotic product for the U.S. and European markets that contains the butyric acid-producing bacterium Clostridium butyricum MIYAIRI 588 (CBM588). CBM588 has been safely used in Japan for over 40 years as a non-antibiotic treatment option for antibiotic-associated diarrhea (AAD) as well as other conditions characterized by disturbances of the GI microflora, including CDI, and irritable bowel syndrome (IBS). CBM588 promotes the restoration of normal microflora and function of colonic epithelium and antagonizes the growth of enteric pathogens through the elaboration of butyric acid and other substances.
A January 2010 editorial in the New England Journal of Medicine highlighted, “new therapies are needed to manage the increasing incidence, severity and high rate of recurrence of Clostridium difficile infection.” The editorial continued, “during the past decade, there has been a striking increase in the prevalence of Clostridium difficile infection and in associated mortality in the United States, Canada and Europe. The widespread use of broad-spectrum antibiotics places patients at risk for C. diff diarrhea or colitis and has changed the epidemiology of infection. This has been characterized by the emergence of a hypervirulent strain of C. diff and an increasing risk of treatment failure and recurrent infection.”
Osel will also be pursuing other clinically important indications for both LACTIN-V and CBM588. In addition to BV, RUTI, and improving the outcome of IVF, data suggests that LACTIN-V may also be preventive for vaginal yeast infections which frequently occur in women post antibiotic therapy. For CBM588, Osel will also be exploring its therapeutic effect on diarrhea-predominant irritable bowel syndrome which may be due to disturbances in gastrointestinal microflora.