Print Page  Close Window

SEC Filings

S-1
VITAE PHARMACEUTICALS, INC filed this Form S-1 on 08/12/2014
Entire Document
 

Table of Contents

      medical cost for ACS is estimated at $75 billion, with a significant portion associated with drug therapy. ACS patients have cholesterol plaque build-up in their blood vessels and specific evidence of risk for an impending heart attack. Patients diagnosed with ACS have a 10-20% incidence of a serious cardiovascular event within six months. Liver X receptors, or LXRs, which include LXRa and LXRb, work to transport cholesterol out of cells and inhibit the production of inflammatory proteins. Several studies have demonstrated that LXR agonists will promote reverse cholesterol transport, or RCT, which is the transport of cholesterol from cells back to liver for excretion from the body, in vivo in mice and prevent the development of atherosclerosis. Our research suggests that it is important to develop LXR modulators that are agonists for LXRb while avoiding activity of LXRa to reduce effects on liver and plasma TGs. VTP-38443, an orally active LXRb selective agonist, works by augmenting RCT, helping remove cholesterol from the plaque in vessel walls and by inhibiting the production of pro-inflammatory proteins around the plaque. Both of these mechanisms make the plaque less inflamed and more stable, which we believe lowers the risk of plaque rupture and blood clot formation that may lead to a heart attack, and could make VTP-38443 a potential complement to current therapies for ACS. In preclinical studies, VTP-38443 decreased plaque formation by more than 60% and lowered the plaque's inflammatory state. We anticipate completing the necessary preclinical studies and filing an IND for VTP-38443 in the first half of 2016, with Phase 1 clinical trials commencing thereafter.

    We are developing VTP-38543 topically for atopic dermatitis, also known as eczema. Atopic dermatitis is a common inflammatory skin disease most commonly seen in children. According to the National Eczema Association, an estimated 31.6 million people in the United States have symptoms of eczema or eczematous conditions. In 2002, it was estimated that third party payors, such as Medicaid and private insurers, incurred costs as high as $3.8 billion for patients 65 and younger. Atopic dermatitis is characterized by a loss of barrier function, which is the impermeable outer layer of the skin, and skin inflammation. Similar to VTP-38443, VTP-38543 transports lipids out of cells and decreases inflammation, in this case in damaged skin tissue. VTP-38543, an LXRb selective agonist, has been shown in preclinical studies to stimulate the development of mature skin cells known as corneocytes as well as to increase the surrounding lamellar body lipids in the skin to improve its barrier function, while also decreasing skin inflammation. In a preclinical model of atopic dermatitis, VTP-38543 has demonstrated equal or superior efficacy versus high potency topical corticosteroids, the current standard of care. We anticipate completing the necessary preclinical studies and filing an IND for VTP-38543 by the second half of 2015, with Phase 1 clinical trials commencing thereafter.

        In addition to our existing product candidates, our team of scientists is currently utilizing Contour in our new discovery program in immuno-oncology.

        Our executive management team and accomplished drug discovery scientists possess substantial experience across the full spectrum of drug discovery, development and commercialization. Our Chief Executive Officer previously held a number of executive and commercial positions at Bristol-Myers Squibb Company, or BMS, including head of BMS' Immunology and Virology divisions. While at BMS, he successfully launched products in several therapeutic areas. Our Chief Scientific Officer was previously head of Clinical Discovery for BMS, where he was involved in the development of all of BMS' compounds from preclinical candidate selection through to human proof-of-concept, including central nervous system agent Abilify (aripriprazole), cardiovascular agent Eliquis (apixaban), oncology agent Erbitux (cetuximab) and Sprycel (dasatinib), virology agent Reyataz (atazanavir) and immunology agent Orencia (abatacept). Three internationally recognized medicinal chemists—two professors of chemistry from Harvard University and a former Merck distinguished scientist now in the American Chemical Society's Hall of Fame—founded our company.

        We seek to aggressively protect our assets by broadly filing patent applications that cover the novel discoveries we create. Each of our most advanced product candidates is the subject of patents and patent

76