Epigenesis Pharmaceuticals is a privately held biopharmaceutical company developing inhaled respiratory medicines for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Epigenesis is focused on inhaled delivery to leverage the enhanced safety profile of topical therapy over systemic therapy. The Company’s lead compound, EPI-12323, is a once daily, small molecule, inhaled non-glucocorticoid steroid that targets the inflammatory and airway obstruction cascade in the irritated lung. EPI-12323 has broad anti-inflammatory and bronchodilator activities, and does not exhibit any of the classical side effects of glucocorticoid steroids, that comprise 30% of all current asthma sales.
Respiratory disease represents one of the most attractive pharmaceutical sectors, with sales expected to grow from the current $30 billion in 2004 to an estimated $65 billion in 2014. Asthma and chronic obstructive pulmonary disease (COPD) represent 40% and 16% of the respiratory market, respectively, and are the initial indications in development by Epigenesis. Allergic rhinitis represents 25% of the respiratory market, and Epigenesis is planning to target this indication in 2005. In 2004, the markets for these disease categories grew at an industry-leading rate of 20% over the prior year.
Our initial target disease, asthma, has been called a national epidemic and COPD is the fourth leading cause of death worldwide. It is estimated that 16 million Americans have COPD and an equal number are undiagnosed. Allergic rhinitis is also growing at alarming rates, especially in children. The need for a new generation of respiratory therapeutics is both great and growing.
In spite of the escalating medical need, only two new therapeutic classes of medicines have been introduced into the marketplace over the past 25 years. We are committed to improving this situation for all patients with common respiratory disease. Epigenesis is creating a series of medicines for the treatment of respiratory diseases through small molecule discovery methods. Our business model is to streamline early clinical development through Phase II studies and then partner our compounds with global pharmaceutical companies. Part of the Company's strategy is to use sophisticated preclinical models to select only those compounds that have the best chance of clinical and commercial success. We create value for our shareholders by maximizing the opportunity for each drug and by reducing risk in clinical development. With our expertise in respiratory medicine and respiratory pharmaceutics, we are able to streamline early clinical development. Our current lead compound, EPI-12323, emerged from a small molecule discovery method that targets asthmatic pathways.
The Company is committed to developing a series of inhaled respiratory medicines through Phase II studies using small molecule discovery methods.
Initial clinical results indicate that EPI-12323 has pronounced anti-inflammatory and bronchodilator activity and does not exhibit any of the classical side effects of glucocorticoid steroids. EPI-12323 does not bind to the glucocorticoid receptor and no adverse effects have been observed on cortisol, bone or androgenic metabolism. In addition, EPI-12323 is effective in reducing airway inflammation and improving airways resistance and compliance and reducing hyperresponsiveness in three preclinical models.
EPI-12323 was identified as a candidate for development in asthma since it is a non-glucocorticoid steroid and due to its ability to delete adenosine pools believed to be important in asthma. EPI-12323 has demonstrated anti-asthma effects in three separate preclinical models of human asthma. Such an extensive evaluation is a part of the Company's strategy to use sophisticated preclinical models to select only those compounds that have the best chance of clinical and commercial success.
The pharmacology profile for EPI-12323 compares favorably to glucocorticoid steroids, and in some cases exceeds the market leading corticosteroid class. Specifically, EPI-12323 exhibits a long duration of action (perhaps once per day treatment) and a pronounced effect on neutrophils. Neutrophils are believed to play an important role in severe asthma cases that result in death, and are also a key effector cell in COPD.
In a Phase II allergen challenge study, EPI-12323 administered daily was safe, well-tolerated and significantly improved pulmonary function and symptoms in mild asthmatic men. The key primary clinical endpoint, reduction in the Late Asthmatic Response, achieved statistical significance. The magnitude of protection achieved is considered clinically important in an asthma model used by many investigators to predict future clinical success. Patients studied had fewer asthma symptoms and reported their breathing had significantly improved. The improvement in asthma symptoms was supported by a reduction in rescue medication use and a reduction in nocturnal awakenings.
As a result of EPI-12323's ability to decrease both eosinophilic and neutrophilic inflammation in the lungs, it is also being developed for COPD. By specifically targeting the neutrophilic inflammation, EPI-12323 is expected to reduce the ongoing tissue destruction and improve small airway obstruction in COPD.
Check back soon for updates on Phase II clinical study results in mild-moderate asthma and moderate-severe COPD patients in three dose groups. Over 250 patients have now been safely dosed with EPI-12323.
Epigenesis is continuing its product development efforts by observing a broader asthma population in a Phase II clinical study using its new formulation in an advanced high-efficiency nebulizer device. Epigenesis expects to complete its Phase II clinical study in a broader asthma population in 2007.
The successful development of EPI-12323 as a single agent opens the opportunity to combine it with other known effective agents in asthma, COPD and other respiratory disorders to maximize the compound’s value. Therefore, EPI-12323 is currently being developed in combination with other drug classes for both asthma and COPD. Using one device to deliver two medications permits customization of the drug combination for individual patient symptoms and offers convenience. For COPD patients, the ability to customize therapy represents a novel approach to a very heterogeneous disease. Epigenesis has completed preclinical pharmacology studies combining EPI-12323 with a long acting beta agonist as well as other drug classes, and has filed patent applications for these combinations.
Our expertise in respiratory medicine and respiratory pharmaceutics enables us to streamline early clinical development thereby saving valuable time and resources.
The Company has a strong portfolio of patents, trademarks and trade secrets that provides strong protection for its therapeutic approach. Epigenesis has strong intellectual property barriers protecting its advanced proprietary preclinical models of human respiratory disease, its compounds (i.e. EPI-12323), and specific product formulations for the treatment of respiratory diseases.
