AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018

BORA Phase III trial for Fasenra in severe eosinophilic asthma is among 43 company abstracts at the Congress, including nine oral presentations

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris. A late-breaking oral presentation of the BORA Phase III trial evaluates the long-term safety and efficacy of Fasenra as an add-on treatment for patients with severe eosinophilic asthma who had previously completed one of the pivotal SIROCCO or CALIMA Phase III trials.

AstraZeneca will also present the latest science on its inhaled combination medicines, including an oral presentation of the KRONOS Phase III trial which evaluates the efficacy and safety of PT010 (budesonide/glycopyrronium/formoterol) triple combination therapy versus dual combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Tom Keith-Roach, Vice President, Respiratory, said: “We believe the long-term safety and efficacy data from the Fasenra BORA Phase III extension trial will be important to physicians, given the strong reception to Fasenra we have seen since the medicine launched in the fourth quarter of 2017. With 43 company abstracts accepted for presentation at ERS, there is a wealth of data across AstraZeneca’s biologics and inhaled combinations which demonstrates our commitment to advancing clinical practice in respiratory disease.”

AstraZeneca and MedImmune key abstracts at ERS 2018 include (all times are CEST):

Fasenra

• Long-term safety and efficacy of benralizumab in severe, uncontrolled asthma: first results of BORA, a randomized, Phase III extension study (Late-Breaker Oral Presentation, abstract OA3567, Tuesday 18 September, 08.30-10.30, session 379, room 7.3Z2)
• Benralizumab efficacy in patients with uncontrolled eosinophilic asthma by age at diagnosis (Poster discussion, abstract PA603, Sunday 16 September, 10.45-12.45, session 86, room 7.2D)

Symbicort Turbuhaler (budesonide/formoterol)

• Risk of a severe exacerbation following higher reliever use: post-hoc analysis of SYGMA 1 in mild asthma (Late-Breaker Oral Presentation, abstract OA1680, Sunday 16 September, 14.45-16.45, session 179, terminal 7)
• Protection by budesonide against clinically important deteriorations (CID) in patients with COPD is dependent on blood eosinophil counts (EOS) (Late-Breaker Oral Presentation, abstract OA5381, Wednesday 19 September, 10.45-12.45, session 553, room 7.3P)
• Adding budesonide to formoterol reduces risk of clinically important deteriorations (CID) in moderate to very severe COPD (Poster discussion, abstract PA2006, Monday 17 September, 08.30-10.30, session 226, room 7.2B)

Bevespi Aerosphere (glycopyrronium/formoterol fumarate)

• Efficacy and safety of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (GFF MDI) delivered using co-suspension delivery technology in Japanese patients with moderate-to-very severe COPD (Thematic poster session, abstract PA1014, Sunday 16 September, 12.50-14.40, session 111, room TP-19)

PT010 (budesonide/glycopyrronium/formoterol fumarate)

• KRONOS: 24-week study of triple fixed-dose combination budesonide/glycopyrronium/formoterol (BGF) MDI via co-suspension delivery technology vs glycopyrronium/formoterol (GFF) MDI, budesonide/formoterol (BFF) MDI and BFF inhalation powder in COPD (Oral presentation, abstract OA1661, Sunday 16 September, 14.45-16.45, session 177, room 7.3P)
• Efficacy and safety of budesonide/formoterol fumarate dihydrate metered dose inhaler (BFF MDI) using co-suspension delivery technology compared to mono-components and an active comparator in COPD (Thematic poster session, abstract PA775, Sunday 16 September, 12.50-14.40, session 99, room TP-07)
• Pharmacokinetics (PK) and safety of budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) and glycopyrronium/formoterol fumarate dihydrate (GFF) metered dose inhaler (MDI) in healthy Chinese adults (Thematic poster session, abstract PA1013, Sunday 16 September, 12.50-14.40, session 111, room TP-19)
• Impact of eosinophil levels on lung function and exacerbation benefits with co-suspension delivery technology budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) in COPD (KRONOS study subgroup analysis) (Late-Breaker Thematic poster session, abstract PA688, Sunday 16 September, 12.50-14.40, session 95, room TP-03)

Potential new medicines and breakthrough research

• The Discovery and Development of AZD1402/PRS-060, an Inhaled, Potent and Selective Antagonist of the IL-4 Receptor Alpha (Thematic poster session, abstract PA1047, Sunday 16 September, 12.50-14.40, Session 113, room TP-21)
• AZD1402/PRS-060, an inhaled Anticalin IL-4Ra antagonist, potently inhibits IL-4 induced functional effects in human whole blood, which can be employed translationally in clinical studies (Poster discussion, abstract PA5248, Wednesday 19 September, 08.30-10.30, session 536, room 7.2B)
• Overlapping biologic exacerbation clusters in asthma and chronic obstructive pulmonary disease have distinct sputum mediator and microbiome profiles (Poster discussion, abstract PA5468, Wednesday 19 September, 10:45-12:45, session 559, 7.2D)

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NOTES TO EDITORS

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2017. AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans pressurised metered-dose inhalers and dry powder inhalers, as well as the Aerosphere Delivery Technology. The Company also has a growing portfolio of respiratory biologics including Fasenra (anti-eosinophil, anti-IL-5rɑ), now approved for severe eosinophilic asthma and in development for severe nasal polyposis, and tezepelumab (anti-TSLP), which is in Phase III trials and achieved its Phase IIb primary and secondary endpoints. AstraZeneca’s research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, US., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, US. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.