United Therapeutics scraps development of esuberaprost after late-stage study failure in PAH

United Therapeutics on Monday announced that it will end development of esuberaprost for the treatment of pulmonary arterial hypertension (PAH) after the oral drug failed to meet the primary endpoint of delayed time to first clinical worsening event in the Phase III BEAT study.  

The 240-patient trial investigated the addition of esuberaprost to the company's inhaled PAH treatment Tyvaso (treprostinil) compared to Tyvaso alone. The primary endpoint was measured by events including death and hospitalisation due to worsening of PAH. Meanwhile, secondary outcome measures included the six-minute walking distance, Borg dyspnoea score and WHO functional class.  

Esuberaprost, a modified-release formulation of beraprost, was developed by United Therapeutics' Lung Biotechnology unit.  

The news comes after Novartis' Sandoz unit launched the first generic version of United Therapeutics' injectable PAH treatment Remodulin (treprostinil) in the US last month. The companies settled a patent infringement lawsuit related to the drug in 2015, one year after a US district court upheld the validity of a patent covering Remodulin. 

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