Advertisement
A Nordic star on a global mission

EpiEndo Pharmaceuticals is on the rise. The company has recently secured next phase financing and been awarded several prestigious awards, and is on course to potentially change the treatment paradigm for chronic obstructive pulmonary disease.
At the Swedish-American Life Science Summit (SALSS) 2021, the Icelandic clinical stage pharma company EpiEndo received the SALSS Rising Star Award for its level of innovation and potential impact in chronic obstructive pulmonary disease (COPD).
COPD is a chronic slow progressing inflammatory lung disease that causes obstructed airflow from the lungs. Patients experience breathing difficulty, cough, and mucus (sputum) production. It is typically caused by long-term exposure to oxidant gases or particulate matter, most often from cigarette smoke and air pollution. People with COPD are also at increased risk of developing heart disease, lung cancer and a variety of other conditions. It is the fourth leading cause of death globally, with a prevalence estimated at more than 257 million cases. Available treatments that address symptoms are primarily inhaled drugs, including long-acting adrenoceptor agonists (LABA), long-acting muscarinic receptor antagonists (LAMA), and corticosteroids (ICS).

Fridrik Gardarsson, Chief Innovation Officer, EpiEndo Pharmaceuticals, Maria Bech, CEO, EpiEndo Pharmaceuticals, and Gunnar Andersson, Honorary Consul of Austria, sponsor of the SALSS Rising Star Award 2021 sculpture.
A new mode of action
Founded in 2014, EpiEndo aims to develop a treatment for the global health challenge presented by COPD by taking a new approach whereby epithelial barrier dysfunction in the lung is viewed as a key driver on inflammation in chronic respiratory diseases.
“We are trailblazing this approach with our first-in-class lead compound EP395 for the treatment of COPD.”
“We have a unique focus on impairment of epithelial barriers as a common mechanism underlying the pathophysiology of many inflammatory conditions in surface-tissues such as the airway mucosa, GI tract and skin,” explains Maria Bech, CEO, EpiEndo. “We are trailblazing this approach with our first-in-class lead compound EP395 for the treatment of COPD.”
EP395, an oral therapeutic candidate, is currently in phase I clinical development. The lead indication is exacerbation reduction in COPD patients with expansion potential into other airway diseases.
“Our primary treatment goal is to prevent or reduce inflammation by preserving and enhancing airway epithelial barrier integrity,” says Bech.
The company’s ”Barriolide” compounds exemplified by EP395 are non-antibiotic analogues of azithromycin that modulate inflammation by strengthening the junctions between respiratory epithelial cells. By targeting the epithelium, EP395 is likely not only to bring additional improvement to the standard of care (SOC) but potentially to alleviate off-label use of antibiotics and overuse of inhaled corticosteroids in the treatment of airway diseases such as COPD, according to Bech.
“Multi-resistant bacteria are a growing threat globally and complications of intense use of corticosteroids comprise a significant concern beyond the disease burden.”
“Multi-resistant bacteria are a growing threat globally and complications of intense use of corticosteroids comprise a significant concern beyond the disease burden. This situation is fueled by the limited responsiveness COPD displays towards SOC and the lack of a safe and effective therapeutic alternative,” she says.

Left: Maria Bech, CEO, EpiEndo Pharmaceuticals. Right: Chronic obstructive pulmonary disease (COPD) is a chronic slow progressing inflammatory lung disease that causes obstructed airflow from the lungs. Photo: iStock
Great impact
Naturally, if brought to patients, EpiEndo’s new treatment could have a significant impact, both on global health as well as economically.
“A COPD diagnosis is considered if a patient experiences any of the following symptoms; dyspnea, chronic cough, or sputum production. Acute worsening of respiratory symptoms is referred to as exacerbations and reduction in exacerbations would benefit the healthcare system since the greatest proportion of the economic burden of COPD comes from hospitalization of severe patients with exacerbations,” says Bech.
The economic burden of COPD is increasing and is estimated to represent over three percent of the total annual healthcare budget in the EU, totaling around 38 billion USD, says Bech. In the US, the direct costs of COPD are estimated to be 32 billion USD annually. In 2019, drug sales in COPD totaled 13 billion USD in the US and EU5&Japan*.
In August, EpiEndo closed a 20 million EUR Series A financing round, led by Iðunn Venture Fund and Flerie Invest, with existing investors ABC Ventures participating, as well as the European Innovation Council (EIC) Fund joining the round. The Series A financing secured funds to advance clinical development of EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a lead indication.
“I am very much looking forward to when the first patient is treated with EP395. That will be a significant milestone for the company.”
“In 2022, we will complete our phase I single and multiple ascending dose study in healthy volunteers with EP395. This is a study evaluating the safety, tolerability and pharmacokinetic properties of our lead compound. In addition, the plan is to bring EP395 into phase II in patients with COPD,” Bech says. “I am very much looking forward to when the first patient is treated with EP395. That will be a significant milestone for the company.”

Team EpiEndo Pharmaceuticals
A virtual model
EpiEndo is an Icelandic company, but the core team is based across Iceland, Sweden, Germany and the UK.
“Our thinking from the start has been to bring the best and most skilled individuals into EpiEndo, regardless of where they are located.”
“Our thinking from the start has been to bring the best and most skilled individuals into EpiEndo, regardless of where they are located. The important thing for us is to have the right competence in the company, and if we have that, we know we are doing our best to make this a success,” says Bech. “On a day-to-day basis we work virtually, which has been a real advantage during the pandemic as this is our normal way of working. We try to meet at least a couple of times per year with the larger team of employees and consultants, and the core team more frequently. However, as for everyone these past 1.5 years, travel has been restricted.”
Being an Icelandic life science company, strategically located between Europe and USA, is an advantage as the local interest in the company in Iceland, as well as abroad, is considerable, continues Bech.
“However, our success results from tapping into the industry tradition and experience available in the Nordics as well as the UK and EU. Our virtual model allows a critical mass of people working in multinational teams across the globe to advance the development of our drugs towards market registration given the essential partnerships, funds, and services.”
“Being part of this is of major importance for us as we grow, both with regard to attracting talent but also access to expertise in the life science area.”
In the Nordics, the company has a strong community within life science, many companies to learn from and experienced people to either hire or consult with, adds Bech.
“Being part of this is of major importance for us as we grow, both with regard to attracting talent but also access to expertise in the life science area,” she concludes.
* Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease (2020 REPORT), Datamonitor report 2020, WHO Fact sheet ‘The top 10 causes of death’ (9dec 2020))
Published: March 9, 2022