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S-1
VITAE PHARMACEUTICALS, INC filed this Form S-1 on 08/12/2014
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      afflicts approximately 85% of type 2 diabetics, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, or TGs, while having decreased levels of high-density lipoprotein, or HDL, cholesterol, HDL-C or "good cholesterol." Cortisol, a steroid hormone made by the body, plays a key role in the pathogenesis, or disease mechanism, of metabolic syndrome. VTP-34072 inhibits 11b hydroxysteroid dehydrogenase type 1, or 11b HSD1, the enzyme responsible for the production of cortisol in tissues where active glucose metabolism takes place, including the liver and adipose, or fat, tissue. In Phase 1 clinical trials involving 142 patients, VTP-34072 was well tolerated and demonstrated highly potent and selective inhibition of 11b HSD1 in adipose tissue, and had a pharmacokinetic profile which we believe is consistent with once-a-day dosing in humans. VTP-34072 commenced the first Phase 2 clinical trial involving 126 type 2 diabetic patients in July 2014 and is expected to have results in the first half of 2015. We are eligible to receive a milestone payment of $6.0 million from BI upon the first patient dosed in this trial.

    VTP-37948 is being developed for Alzheimer's. Alzheimer's is a devastating disease that causes problems with memory, thinking and behavior. According to the Alzheimer's Foundation of America, an estimated 5.1 million Americans had Alzheimer's as of 2013 and the average annual cost of care for Alzheimer's patients over the age of 70 in the United States was estimated to be between $157 billion and $210 billion in 2010. Alzheimer's is characterized by the accumulation of extracellular protein deposits in the brain that are called amyloid plaques. The accumulation of these plaques is believed to directly damage neurons and to trigger additional responses that further contribute to the disease. Amyloid production begins with an enzyme in the brain known as b-Site Amyloid Precursor Protein Cleaving Enzyme 1, or BACE. There are significant genetic data that implicate BACE as playing a direct role in the disease process itself. We discovered and are developing VTP-37948, a BACE inhibitor, in collaboration with BI. In preclinical studies, VTP-37948 demonstrated highly potent and selective inhibition of BACE in the brain, with up to 95% lowering of brain amyloid beta levels. VTP-37948 is currently in two Phase 1 clinical trials involving a total of 68 healthy volunteers. The first clinical trial includes endpoints of safety, tolerability and pharmacokinetics. The second clinical trial looks at the effects of VTP-37948 on a key biomarker of activity, amyloid beta concentration in the cerebrospinal fluid. Results from both of these clinical trials are expected in the second half of 2014.
    We are developing VTP-43742 for autoimmune disorders. Autoimmune disorders comprise a large number of disease conditions where the body mounts an inappropriate immune response against normal, healthy tissues. These disorders include commonly known diseases such as psoriasis, multiple sclerosis, or MS, and rheumatoid arthritis, or RA, as well as rarer conditions such as Behcet's disease and autoimmune uveitis. Increased activity of a class of lymphocytes called Th17 cells is a critical part of the pathophysiology of many human autoimmune disorders. RAR-Related Orphan Receptor gamma-t, or RORgt, is a nuclear hormone receptor that is essential for the formation and function of these Th17 cells. Preclinical studies in animal models have demonstrated that inhibition of RORgt activity is beneficial for the treatment of multiple autoimmune disorders. In preclinical studies, VTP-43742 has been shown to inhibit the secretion of Interleukin 17, or IL-17, and other cytokines, which are pro-inflammatory proteins, from Th17 cells, and has been demonstrated to be therapeutically beneficial in an animal model of MS. These studies also show that VTP-43742 is well absorbed after oral administration in multiple animal species and has a long half-life in plasma, which we believe is consistent with once-a-day dosing in humans. We plan to file an Investigational New Drug Application, or IND, with the U.S. Food and Drug Administration, or FDA, for VTP-43742 in the first half of 2015, with Phase 1 clinical trials commencing thereafter. We expect to have Phase 1 proof-of-concept data by the end of 2015.
    We are developing VTP-38443 for acute coronary syndrome, or ACS. According to the American Heart Association, as of 2005, there were approximately 1.4 million hospital discharges in the United States due to ACS. In an article published in the American Journal of Managed Care, the economic impact of ACS is estimated to be greater than $150 billion annually and the direct

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