Nuance Pharma’s Ohtuvayre (ensifentrine) has met the primary endpoint in a Phase III chronic obstructive pulmonary disease (COPD) study in China.
The medication was developed as part of a partnership with UK company Verona Pharma.
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In the ENHANCE-CHINA trial (NCT05743075), nebulised Ohtuvayre showed a statistically significant and clinically meaningful improvement in change in forced expiratory volume (FEV) of 110ml after 12 weeks.
The trial also showed improvement in lung function, including a peak FEV of 174mL, a morning trough FEV increase of 36ml and an evening trough FEV increase of 65ml.
Patients also receiving saw a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks, and there was a decrease in the risk of a moderate/severe exacerbation, measured by time to first exacerbation of 25%.
There was also improvement in secondary endpoints, including dyspnea as measured by the Transition Dyspnea Index (TDI) of 0.8 compared to placebo over 24 weeks.
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By GlobalDataQuality of Life (QoL), as measured by the St George’s Respiratory Questionnaire (SGRQ) Total Score in the Ohtuvayre arm, also improved by -2.9, higher than the Minimal Clinically Important Difference (MCID) of -4.
The therapy remained well-tolerated with adverse event (AE) incidence similar to placebo.
Nuance Pharma CEO Mark Lotter said: “These promising results demonstrate Ohtuvayre’s strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options.”
Nuance Pharma plans to submit a new drug application to China’s National Medical Products Administration (NMPA) in the second half of 2025.
Nuance Pharma gained development rights in China from Verona
Shanghai-based Nuance gained rights to Ohtuvayre in June 2021 after signing a $219m strategic collaboration with Verona Pharma. The collaboration gave Nuance Pharma development and commercial rights in Greater China.
Ohtuvayre is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects delivered through a standard jet nebuliser.
The drug was approved by the US Food and Drug Administration (FDA) on 26 June 2024 for use in adult COPD patients. Approval for use in Europe has yet to be granted.
Nuance Pharma plans to release additional information from ENHANCE-CHINA at upcoming scientific conferences.
According to GlobalData, Ohtuvayre could reach global sales of $1.63bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
