 Emisphere's Oral PYY3-36 Program
Emisphere has demonstrated oral delivery of PYY3-36 in rodents and non-human primates using the eligen® oral drug delivery technology.
Results from Emisphere's studies in rodents demonstrated that oral administration can achieve therapeutically relevant blood PYY levels. The bio-efficacy of Oral PYY3-36 was evaluated by measuring post-dose food intake in rodents. During the first four hours post-dose, food intake in the animals treated with Oral PYY3-36 was 38% lower than in the animals dosed with placebo (P < 0.01).The effect of Oral PYY3-36 on weight gain was evaluated in a seven-day study in which animals received daily doses of Oral PYY3-36 or placebo. At the end of the study, the weight gain in the group receiving oral PYY3-36 was 48% lower than in the placebo group (P < 0.05). The results from these studies demonstrate the feasibility of Oral PYY3-36 administration and present an opportunity to develop an oral dosage form of PYY3-36 for the treatment of obesity.
Market Opportunity / Expansion
The most recent figures from the Centers for Disease Control and Prevention show that 65 percent of U.S. adults - or about 129.6 million people - are either overweight or obese, a condition that substantially raises their risk of morbidity from hypertension, dyslipidemia, Type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and respiratory problems, and endometrial, breast, prostate, and colon cancers. Higher body weights are also associated with increases in all-cause mortality. As the second leading cause of preventable death in the United States today, obesity poses a major public health challenge. In addition to decreasing quality of life and increasing the risk of premature death, obesity costs the Nation an estimated $117 billion in direct medical costs and indirect costs such as lost wages due to illness.
Due to the rising obese population and associated risks, the FDA has granted a fast track drug development process for drugs treating obesity.
About PYY3-36
Peptide YY (PYY) is a gastrointestinal hormone secreted post-prandially (after a meal) by the endocrine cells of the distal gastrointestinal tract in proportion to the caloric content of a meal. PYY is secreted in two forms, PYY1-36 and PYY3-36.
There is published clinical evidence that elevated PYY levels contribute to weight loss and decreased food intake. In addition, studies have shown that blood levels of PYY are drastically elevated in individuals who have undergone
gastric bypass surgery, an effective treatment for morbid obesity.
In a study published in The New England Journal of Medicine in September 2003, it was shown that blood PYY levels are lower in obese than in lean subjects. The same study showed that after intravenous infusion of PYY3-36, caloric intake decreased by about 30% in both obese and lean subjects. PYY3-36 infusion also caused a significant decrease in the cumulative 24-hour caloric intake in both groups. No resistance to PYY3-36 was observed in obese subjects. These results suggest that PYY3-36 may be a beneficial therapeutic option for obesity. An oral form of PYY would be patient friendly and ensure compliance to the dosing regimen.
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