United Therapeutics reported that following disappointing results from the BEAT study (NCT01908699), the company has decided to discontinue the development of esuberaprost for the treatment of pulmonary arterial hypertension (PAH).
The phase 3 multicenter, double-blind, randomized, placebo-controlled study (N=240) was designed to assess the safety and efficacy of esuberaprost tablets as an add-on to inhaled treprostinil (Tyvaso) in PAH patients. Adult patients (aged 18 to 80 years) were randomized to either esuberaprost 15mcg (1 or 2 tablets 4 times daily) or placebo. Treprostinil-naive patients were entered into a 90-day run-in period to ensure drug tolerability.
The primary outcome measure was time to clinical worsening defined as time from randomization to the first of any of the following events: all-cause mortality, hospitalization due to worsening PAH, initiation of a parenteral prostacyclin (directly related to worsening PAH), disease progression, or unsatisfactory long-term clinical response. Assessments were made every 4 weeks for the first 12 weeks post-randomization and then every 12 weeks up to 144 weeks.
Results showed that the study did not meet its primary endpoint of delayed time to first clinical worsening event.
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