OUR CLINICAL FOCUS
Addressing the growing burden of airway diseases
EpiEndo is developing first-in-class, disease-modifying drugs to address the global burden and high unmet need of chronic obstructive pulmonary disease (COPD) and viral airway diseases. COPD (chronic bronchitis and emphysema), asthma and cystic fibrosis are chronic lung diseases associated with chronic airway inflammation and epithelial dysfunction. Airway diseases represent some of the most important public health challenges because of their high prevalence, estimated at more than a quarter of a billion cases worldwide in 2019, increasing incidence and related disability and mortality.
There are currently no effective drugs that modify the long-term decline in lung function that characterises COPD. The Company’s data supports a new paradigm that epithelial barrier insufficiency in the lung is a key driver of inflammation in chronic respiratory diseases. EpiEndo's proprietary macrolide compounds exhibit a novel mechanism that enhances the integrity of the epithelial cell layer in the lung, which we believe may slow progression through reduction of underlying disease pathology.
THE GLOBAL BURDEN OF COPD
COPD is a slow progressing chronic respiratory disorder characterised by an obstructive ventilatory pattern which is not fully reversible. The primary causes of COPD in the developed world are tobacco smoking and pollution, while in developing countries, cooking over open fires is a major cause. Cigarettes are smoked by more than 1.1 billion people, nearly 20% of the world's population, while according to the WHO more than 3 billion people around the world cook their food and heat their homes with open or barely contained fires¹. A typical cooking fire produces about 400 cigarettes’ worth of smoke an hour.
UNMET NEED IN CURRENT MANAGEMENT OF COPD
COPD is currently incurable. Today, management of COPD currently relies primarily on inhaled drugs, including long-acting adrenoceptor agonists (LABA), long-acting muscarinic receptor antagonists (LAMA), and corticosteroids (ICS), however these treatments address symptoms only. Despite 50 years of active research in this pharmacotherapeutic area, there are still no clinical trials showing that any existing medications for COPD modify the long-term decline in lung function that characterises this disease.
CLINICAL TREATMENT GOALS
Exacerbations are attacks of restricted breathing, characterised by breathlessness, that become worse as the disease progresses, ultimately leading to death. Early intervention and avoidance of disease progression is therefore critical and EpiEndo's clinical treatment goal is to reduce the frequency, duration and severity of exacerbations.
REF (1) WHO: Indoor air pollution and household energy: the forgotten 3 billion
https://www.who.int/news-room/fact-sheets/detail/household-air-pollution-and-health
COPD is responsible for ~5% of all deaths, with a prevalence estimated at more than 257 million cases globally.
The US + EU5 market for COPD therapeutics is expected to exceed $20 billion by 2026 (CAGR 3.1%), rising from $15 billion in 2016
COPD burden is related to the frequency, duration and severity of exacerbation
FEV1/FVC ratio is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease, representing the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The result of this ratio is expressed as FEV1%.
A NEW APPROACH TARGETING THE EPITHELIAL BARRIER
Almost all drug development efforts for COPD continue to focus on an anti-inflammatory approach to treatment.
EpiEndo has strong support from world-leading KOLs for a new paradigm: that epithelial barrier insufficiency is a key driver of inflammation in chronic respiratory diseases.
It has been shown that patients with COPD exhibit increased leakage across the lung epithelium. EpiEndo's compounds enhance the epithelial barrier, appearing to strengthen the junctions between cells and reducing leakage across the epithelium.
Azithromycin has been demonstrated to reduce exacerbations of COPD that are caused by bacterial and/or viral infections and air pollution, but when used chronically can lead to anti-microbial resistance. EpiEndo’s compounds are azithromycin analogues lacking anti-microbial activity, that have shown promising results for inhibiting airway inflammation and restoring epithelial integrity in preclinical models.