- Primary endpoint was met, with once-daily QVM149 demonstrating statistically significant improvement in lung function versus QMF1491,2

- Further data findings from other QVM149 clinical studies presented by Novartis at European Respiratory Society (ERS) International Congress 2019

TOKYO and LONDON /PRNewswire/ -- Sosei Group Corporation ("the Company"; TSE: 4565) notes that Novartis has announced positive results from its Phase III IRIDIUM trial.

The results showed that the investigational, once-daily, inhaled combination QVM149 (indacaterol acetate, glycopyrronium bromide* and mometasone furoate or IND/GLY/MF) achieved a superior improvement in lung function than QMF149 (indacaterol acetate and mometasone furoate or IND/MF) in asthma patients who were uncontrolled on treatment with a long-acting beta agonist/inhaled corticosteroid (LABA /ICS)¹.

In meeting the primary endpoint, QVM149 was shown to be superior to QMF149 in improving trough forced expiratory volume in one second (FEV₁) after 26 weeks. QVM149 was generally well tolerated, and safety was comparable across treatment arms¹.

The key secondary endpoint was improvement in Asthma Control Questionnaire (ACQ-7) score for QVM149 versus QMF149. Tested treatments delivered clinically meaningful improvements in this measure of symptoms from baseline at Week 26, but the key secondary endpoint was not met¹. Among other secondary endpoints, IRIDIUM explored reduction of asthma exacerbation rates, where a substantial reduction was observed in moderate-to-severe and severe asthma exacerbation rates with QVM149 compared with an established LABA/ICS standard of care (twice-daily salmeterol/fluticasone 50/500 µg)¹.

Detailed results from the IRIDIUM trial will be presented at upcoming medical congresses.

As previously announced, the regulatory submission for QVM149 was accepted for review by the European Medicines Agency in May 2019. QVM149 is also being investigated in the Phase IIIb ARGON study³, which compares it with a combination of salmeterol/fluticasone and tiotropium. Results from the completed ARGON study will be announced after the data are analyzed.

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, said: "We are pleased to see that QVM149, a novel combination therapy, continues to generate positive clinical data that support its potential to become new treatment option for patients with uncontrolled asthma. We look forward to additional results from this study and others, such as the ARGON study, which we hope will further demonstrate the clinical benefits of QVM149 for these patients."

Further clinical data from the broader development program of Novartis with QVM149 are being presented at the European Respiratory Society (ERS) International Congress 2019 (28 September – 2 October, Madrid, Spain). The abstracts and posters are available to view on the ERS International Congress 2019 website.

About the IRIDIUM Clinical Trial²

IRIDIUM is a Phase III, multicenter, randomized, double-blind, parallel-group study, designed to compare the efficacy and safety of QVM149 (IND/GLY/MF) with QMF149 (IND/MF) in patients with asthma. The purpose of the trial was to evaluate the efficacy and safety of two different doses of IND/GLY/MF (150/50/80 μg and 150/50/160 μg) versus two respective IND/MF doses (150/160 μg and 150/320 μg) in uncontrolled patients with asthma, as determined by pulmonary function testing and effects on asthma control.

All patients were required to be symptomatic at screening despite being on treatment with medium or high stable doses of LABA/ICS. Approximately 3,092 male and female adult patients with asthma were randomized 1:1:1:1:1 (approximately 618 patients in each of the treatment groups)¹ to receive either:

• IND/GLY/MF 150/50/80 μg (once daily)
• IND/GLY/MF 150/50/160 μg (once daily)
• IND/MF 150/160 μg (once daily)
• IND/MF 150/320 μg (once daily)
• Salmeterol xinafoate/fluticasone propionate (SFC) 50/500 μg (twice daily, via Accuhaler®)

The primary objective of this study was to demonstrate superiority of either IND/GLY/MF 150/50/80 μg versus IND/MF 150/160 μg or IND/GLY/MF 150/50/160 μg versus IND/MF 150/320 μg, all delivered once daily, in improving trough FEV₁ (volume of air that can be forced out in the first second of expiration approximately 24 hours post administration of study drug) after 26 weeks of treatment in patients with asthma.

The key secondary objective was to demonstrate the superiority of either IND/GLY/MF 150/50/80 μg versus IND/MF 150/160 μg or IND/GLY/MF 150/50/160 μg versus IND/MF 150/320 μg, in improvement of ACQ-7 after 26 weeks of treatment in patients with asthma.

Other secondary endpoints also included reduction of exacerbation rate, comparing IND/GLY/MF 150/50/80 μg to IND/MF 150/160 μg and IND/GLY/MF 150/50/160 μg to IND/MF 150/320 μg. Exacerbation rate was also measured for both doses of IND/GLY/MF compared to SFC (50/500 μg).

Full information on all of the endpoints measured in the study can be accessed at ClinicalTrials.gov (Identifier: NCT02571777).

About Uncontrolled Asthma

Patients with asthma who have poor symptom control or frequent exacerbations despite current therapy may be considered uncontrolled. International guidelines such as ERS/ATS criteria developed by The European Respiratory Society/American Thoracic Society Task Force and Global Initiative for Asthma (GINA) provide exact definitions depending on the frequency of symptoms, reliever use, activity limitation and exacerbations^4,5.

Despite current therapy, over 40% of patients with asthma at GINA Step 3, and over 45% at GINA Steps 4 and 5 remain uncontrolled^4,6. Uncontrolled asthma patients may downplay or underestimate the severity of their disease, and are at a higher risk of exacerbation, hospitalization or death^7,8,9. Unresolved barriers such as treatment mismatch, safety issues with oral corticosteroid, and ineligibility for biologics have created an unmet medical need in asthma^10,11.

Enquiries:

Sosei Heptares 
Investor Relations and Corporate Communications
Shinichiro Nishishita, Mai Kurokawa
+81-(0)-352-103-399
IR@SoseiHeptares.com

Citigate Dewe Rogerson (for Japanese media)
Yas Fukuda
+81-(3)-43-609-241
Yas.Fukuda@citigatedewerogerson.com

Citigate Dewe Rogerson (for International media)
Mark Swallow, David Dible
+44-(0)-207-638-9571
SoseiHeptares@citigatedewerogerson.com

*Glycopyrronium bromide and certain intellectual property relating to its use and formulation were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura Group PLC (LSE: VEC). Novartis is responsible for the development and commercialization of QVM149. Under the agreement, Sosei Heptares is entitled to certain development and sales-based milestones, and royalties on net sales upon successful commercialisation of QVM149. The event reported today, however, does not generate a milestone payment and therefore has no immediate impact on the consolidated financial results for the accounting period ending December 2019.

References

1.  Data on file.

2.  Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT02571777. Accessed September 2019

3.  ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT03158311. Accessed September 2019

4.  Chung KF et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343-73

5.  Global Initiative for Asthma. Difficult-to-treat and severe asthma in adult and adolescent patients. A GINA pocket guide. 2019. Available from www.ginasthma.org/

6.  Fang J et al. Demographic, clinical characteristics and control status of pediatric, adolescent, and adult asthma patients by GINA Step in a US longitudinal cohort. Am J Resp Crit Care Med 2018: 197:A1903

7.  Peters SP et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006: 100(7): 1139-1151

8.  Katsaounou P et al. Still Fighting for Breath: a patient survey of the challenges and impact of severe asthma. ERJ Open Res 2018: 4(4)

9.  Price D et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014: 24: 14009.

10.  Price D, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018: 11: 193-204

11.  Albers FC et al. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma 2018: 55(2): 152-160.

Breezhaler® is a registered trademark of Novartis AG.

Forward-looking statements

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