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S-1
VITAE PHARMACEUTICALS, INC filed this Form S-1 on 08/12/2014
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achieved animal proof-of-concept, which is the demonstration of activity in an animal, for each of our programs in less than 18 months from the initiation of a program.

Our Most Advanced Product Candidates

        The following table summarizes key information about our most advanced product candidates.

PRODUCT
CANDIDATE
  INDICATION
(TARGET)
  WORLDWIDE
COMMERCIAL
RIGHTS
  STAGE OF CLINICAL DEVELOPMENT AND
ANTICIPATED MILESTONES
VTP-34072   Type 2 Diabetes and metabolic syndrome   BI  

Phase 2 clinical trial initiated in July 2014

    (11b HSD1)      

Results expected in first half of 2015

             
VTP-37948   Alzheimer's Disease (BACE)   BI  

Phase 1 clinical trial initiated in first half of 2014

           

Phase 1 clinical biomarker trial initiated in first half of 2014

           

Results for both trials expected in second half of 2014

             
VTP-43742   Psoriasis, Multiple Sclerosis, other autoimmune diseases (RORgt)   Vitae  

Phase 1 clinical trial expected to begin in first half of 2015

Phase 1 proof-of-concept results expected by end of 2015

             
VTP-38443   Acute Coronary Syndrome (LXRb)   Vitae  

Phase 1 clinical trial expected to begin in first half of 2016

             
VTP-38543   Atopic Dermatitis (LXRb)   Vitae  

Phase 1 clinical trial expected to begin in second half of 2015

VTP-34072

        VTP-34072 is being developed for type 2 diabetes. We expect VTP-34072 to be differentiated from other oral anti-diabetic agents because, based on its mechanism of action and our preclinical data, it lowers glucose and also has a positive impact on multiple cardiovascular and metabolic risk factors associated with metabolic syndrome. Patients with metabolic syndrome, which afflicts approximately 85% of type 2 diabetics, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of high-density lipoprotein, or HDL, cholesterol, HDL-C or "good cholesterol." Cortisol plays a key role in the pathogenesis, or disease mechanism, of metabolic syndrome. VTP-34072 is designed to inhibit 11b hydroxysteroid dehydrogenase type 1, or 11b HSD1, the enzyme responsible for production of cortisol in tissues where active glucose metabolism takes place, including the liver and adipose, or fat, tissue. VTP-34072 is partnered with BI. In Phase 1 clinical trials in 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 is expected to commence a Phase 2 clinical trial involving 126 type 2 diabetic patients in July 2014 and is expected to report data 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

        VTP-37948 is being developed for treatment of Alzheimer's. 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

 

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