Esuberaprost

Unassigned

New Medicines

Pulmonary arterial hypertension - in combination with treprostinil (modified-release formulation)

Information

New molecular entity
Lung Biotechnology PBC
Lung Biotechnology PBC

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 19 · Development of Esuberaprost has been discontinued following data from the BEAT study [5].

Category

Prostacyclin analogue that dilates blood vessels, prevents platelet aggregation and prevents proliferation of smooth muscle cells surrounding blood vessels
The estimated annual incidence of PAH in the UK general population ranges from 0.9 to 7.6 cases per 1,000,000 people and the estimated prevalence of PAH in the UK general population is between 6.6 and 26 per 1,000,000 people. These figures are thought to be underestimates due to misdiagnosis or underdiagnoses of PAH patients [1].
Pulmonary arterial hypertension - in combination with treprostinil (modified-release formulation)
Oral

Trial or other data

Apr 19 · Esuberaprost tablet did not meet its primary endpoint in the BEAT Phase III clinical trial in pts with PAH. The primary endpoint of delayed time to first clinical worsening event was not met [5].
Sep 18 · The PIII open-label extension trial (BEAT OLE, NCT03657095) was scheduled to start in December 18, with an estimated primary completion date of Dec 20 [4].
Apr 18 · Enrolment in the BEAT trial is complete. Collection of primary outcome data (time to clinical worsening defined as time from randomization to the first of any of the following: Death (all causes), hospitalisation due to worsening PAH, initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH, disease progression, unsatisfactory long-term clinical response) is due to complete Oct 18 [2,3].
May 13 · PIII trial of esuberaprost 240 adults with pulmonary arterial hypertension starts (BEAT; NCT01908699). The trial will evaluate the efficacy and safety of esuberaprost in combination with inhaled treprostinil. Recruitment of patients is underway in the US [2].