Phase III study of Trelegy Ellipta meets primary endpoint

GlaxoSmithKline (LSE: GSK) and Innoviva. (Nasdaq: INVA) have announced positive headline results from the pivotal Phase III CAPTAIN study of already marketed once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients living with uncontrolled asthma.

The study met its primary endpoint, demonstrating a statistically-significant 110mL improvement in lung function (measured by change from baseline in trough FEV1 at 24 weeks of treatment) for FF/UMEC/VI 100/62.5/25mcg (p<0.001, 95% CI: 66-153 mL) compared with Relvar/Breo 100/25mcg and a statistically-significant 92mL improvement in trough FEV1 for FF/UMEC/VI 200/62.5/25mcg versus Relvar/Breo 200/25mcg (p<0.001, 95% CI: 49-135 mL).

Innoviva investors seemed surprise by the result, revealed late Thursday, sending the company’s stock up 7% to $14.94) yesterday, while GSK gained 1.05% to 1,563 pence this morning.

Analysts at HSBC project £1.4 billion in Trelegy revenue by 2023, also helped by future use against asthma, though chronic obstructive pulmonary disease (COPD) will likely remain the larger commercial opportunity.EvaluatePharma sell-side consensus sees Trelegy sales climbing from $208 million last year to $1.4 billion in 2024.