Press release
May 22, 2019

Sosei Heptares notes new positive Phase II data for QVM149, a potential novel inhaled combination for treating asthma, were presented at ATS 2019


Tokyo, Japan and London, UK, 22 May 2019 – Sosei Group Corporation (“the Company”; TSE: 4565) notes that its partner Novartis presented key Phase II data for QVM149, a potential new inhaled combination therapy for asthma, at the 2019 annual international congress of the American Thoracic Society (ATS) in Dallas, USA (17–22 May 2019).

QVM149 is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF), delivered with the dose-confirming Breezhaler® inhalation device. 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, which is currently being investigated in a Phase III clinical program expected to complete in Q3 2019.

In two Phase II clinical studies[1], QVM149 was shown to be superior to the comparators, salmeterol/fluticasone propionate (the standard-of-care treatment) and placebo, separately by demonstrating improvement in lung function in patients with asthma. In one study, QVM149 also demonstrated improvements versus placebo irrespective of administration time of morning or evening. The safety data from both studies also suggest that QVM149 has a favorable safety and tolerability profile. 

“These data continue to support QVM149’s therapeutic benefits in patients with asthma,” said Shinichi Tamura, Chairman, President and CEO of Sosei Heptares. “We look forward to results from the Phase III clinical program and further progress in the development of this novel inhaled combination therapy.”

The abstracts presented by Novartis at ATS 2019 are available at the links below – the presented posters and a summary of key findings have also been added to the Science Center section of our website.

Abstract A1277/P665: Watz, H. et al. The Combination of Indacaterol / Glycopyrronium / Mometasone Furoate is Superior to High-Dose Salmeterol/Fluticasone Propionate in Improving Lung Function in Patients with Asthma

Abstract A7081/503: Beier, J. et al. The Efficacy of the Combination Indacaterol / Glycopyrronium / Mometasone Furoate is Independent of Time of Dosing in Patients with Asthma

 

* Breezhaler® is a registered trademark of Novartis AG.

 

[1] 

Phase II CQVM149B2208 study (ClinicalTrials.gov Identifier: NCT03063086)
Phase II CQVM149B2209 study (ClinicalTrials.gov Identifier: NCT03108027)

 

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