Nuance seeks China approval for Ohtuvayre following Phase III trial success

Nuance Pharma’s Ohtuvayre (ensifentrine) has met the superior endpoint successful a Phase III chronic obstructive pulmonary illness (COPD) survey successful China.

The medicine was developed arsenic portion of a concern with UK institution Verona Pharma.

In the ENHANCE-CHINA proceedings (NCT05743075), nebulised Ohtuvayre showed a statistically important and clinically meaningful betterment successful alteration successful forced expiratory measurement (FEV) of 110ml aft 12 weeks.

The proceedings besides showed betterment successful lung function, including a highest FEV of 174mL, a greeting trough FEV summation of 36ml and an evening trough FEV summation of 65ml.

Patients besides receiving saw a 28% simplification successful the complaint of moderate/severe COPD exacerbations implicit 24 weeks, and determination was a alteration successful the hazard of a moderate/severe exacerbation, measured by clip to archetypal exacerbation of 25%.

There was besides betterment successful secondary endpoints, including dyspnea arsenic measured by the Transition Dyspnea Index (TDI) of 0.8 compared to placebo implicit 24 weeks.

Quality of Life (QoL), arsenic measured by the St George's Respiratory Questionnaire (SGRQ) Total Score successful the Ohtuvayre arm, besides improved by -2.9, higher than the Minimal Clinically Important Difference (MCID) of -4.

The therapy remained well-tolerated with adverse lawsuit (AE) incidence akin to placebo.

Nuance Pharma CEO Mark Lotter said: "These promising results show Ohtuvayre’s spot arsenic a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, arsenic an beforehand to existing attraction options.”

Nuance Pharma plans to taxable a caller cause exertion to China’s National Medical Products Administration (NMPA) successful the 2nd fractional of 2025.

Shanghai-based Nuance gained rights to Ohtuvayre successful June 2021 aft signing a $219m strategical collaboration with Verona Pharma. The collaboration gave Nuance Pharma improvement and commercialized rights successful Greater China.

Ohtuvayre is simply 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 done a modular pitchy nebuliser.

The cause was approved by the US Food and Drug Administration (FDA) connected 26 June 2024 for usage successful big COPD patients. Approval for usage successful Europe has yet to beryllium granted.

Nuance Pharma plans to merchandise further accusation from ENHANCE-CHINA astatine upcoming technological conferences.

According to GlobalData, Ohtuvayre could scope planetary income of $1.63bn successful 2030.

GlobalData is the genitor institution of Clinical Trials Arena.