The Asthma and Allergy Foundation of America is sharing this press release from Circassia Pharmaceuticals, Inc. to bring you the latest research news quickly.

[PRESS RELEASE]

Global Initiative for Asthma (GINA) Recommends the Use of Fractional Exhaled Nitric Oxide (FeNO) Monitoring for Difficult-to-Treat and Severe Asthma Management

MORRISVILLE, NC – Circassia Pharmaceuticals, Inc. (“Circassia” or “the Company”), a specialty pharmaceutical company focused on respiratory disease, today announced that Fractional Exhaled Nitric Oxide (FeNO) monitoring is recommended in the latest Global Initiative for Asthma (GINA) guide, “Difficult-to-Treat & Severe Asthma in Adolescent and Adult Patients – Diagnosis and Management.”

Asthma is a chronic inflammatory respiratory disease. During airway inflammation associated with allergic/eosinophilic asthma, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. Measuring the concentration of NO in exhaled breath, or fractional exhaled nitric oxide, can help identify airway inflammation. Circassia’s innovative NIOX® technology provides objective and accurate FeNO measurement of airway inflammation, and is the only FeNO testing device in the US available at point-of-care.

The new GINA guide recommends FeNO measurement as an assessment tool to determine whether patients who are on high-dose inhaled corticosteroids (ICS) or low-dose oral corticosteroids (OCS) have residual inflammation. This can provide a potential predictor of good response to anti-immunoglobulin E (anti-IgE) therapy for patients with severe, allergic asthma, and is a tool to identify refractory type 2 inflammation in patients on high-dose ICS therapy.

The guide suggests repeating FeNO measurement up to three times when asthma worsens before deciding if it is non-type 2. For patients with elevated type 2 biomarkers on high-dose ICS, FeNO monitoring is recommended to assess adherence before prescribing a biologic. Lastly, FeNO measurement is suggested as a means of monitoring tapering of oral corticosteroid treatment.

David Acheson, Senior Vice President, US Commercial, said: “The new GINA guidelines build on an earlier US Agency for Healthcare Research and Quality (AHRQ) report in terms of the strength of FeNO as a practical tool that improves outcomes for asthma patients. This GINA guide focuses on difficult-to-treat and severe asthma, which can be particularly devastating to patients and costly to the healthcare system in terms of physician visits, medication, hospitalization and management of treatment side effects. The strength of the guidance leaves no question about the role of NIOX in the successful diagnosis and management of asthma patients”.

Circassia recently announced that major insurer Aetna updated its policy to deem FeNO by NIOX as “medically necessary” as a part of comprehensive asthma diagnosis and management. Today, NIOX testing is considered affordable and accessible for both patients and their physicians, as an estimated 80 percent of American lives have insurance coverage for NIOX testing.

About Difficult-to-Treat and Severe Asthma
Asthma often begins in childhood, but can affect people of any age. The disease is characterized by attacks (exacerbations) of breathlessness and wheezing of varying severity and frequency, which if left untreated, can be life-threatening. Asthma is a common condition, with the World Health Organization estimating 235 million people have the condition worldwide. Asthma affects approximately 25 million people in the United States.

GINA estimates that 17 percent of asthma patients are considered “difficult-to-treat”, such that their asthma is uncontrolled despite treatment with a medium or high dose inhaled corticosteroid, with a second controller and maintenance oral corticosteroid therapy, or requires such treatment to maintain good symptom control and reduce the risk of exacerbations. An estimated 3.7 percent of asthma patients are considered “severe” in that asthma is uncontrolled despite adherence with maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased. According to GINA, type 2 inflammation is found in approximately half of people who have severe asthma.

GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute (NIH) and the World Health Organization. Embracing the issue of severe asthma was a critical goal for the GINA Board of Directors and Science Committee, as their mission remains focused on maximizing benefit for patients with asthma while minimizing healthcare provider burden.

About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany, and in a wide range of other countries through its network of partners. In 2017, the Company established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the commercial rights to NDA-stage COPD product Duaklir®. For more information please visit www.circassia.com.

Contact:
RNT Communications
Rebecca Novak Tibbitt
Phone: (704) 341-1544