Bayer's pulmonary hypertension drug Adempas reaches its primary endpoint in Phase IV clinical trial

CompileKe Ke

On March 29, Bayer announced the publication of Phase IV clinical data of the pulmonary hypertension drug Adempas (riociguat) in The Lancet Respiratory Medicine.

"The Lancet" showed that in the treatment study of phase IV clinical replacement results (Riociguat instead of PDE-5i therapy), adult patients with moderate risk of PAH had insufficient response to phosphodiesterase-5 inhibitor (PDE5i) treatment and then turned For Adempas treatment, specific data show that 41% of patients transitioning to Adempas treatment achieved clinical improvement without clinical deterioration (death from any cause, hospitalization due to PAH deterioration or disease progression), while the PDE5i treatment group achieved clinical improvement 20% of patients improved (odds ratio [OR]=2.

In a 12-week multi-center, double-blind, randomized, placebo-controlled, pivotal PATENT-1 study, the aim was to observe that Adempas treatment has not received treatment or received ERA treatment or prostaglandin drugs (oral, inhaled or subcutaneous injection) ) Effectiveness and safety of pre-treated adult patients with PAH (n=443).

6-minute walking distance (6MWD) 36 meters (95% CI: 20 meters-52 meters; p<0.

World Health Organization functional classification (FC; p=0.

Time to clinical deterioration (TTCW; p=0.

Pulmonary vascular resistance (-226 dyn·s·cm-5; 95% CI: -281 to -170], p<0.

N-terminal b-type natriuretic peptide precursor (NT-proBNP; -432ng/mL [95%CI: -782 to -82], p<0.

In this study, compared with placebo, the most common adverse events (≥3%) in the Adempas group were headache (27% vs.

PAH is a hemodynamic and pathophysiological state in which the pulmonary artery pressure rises above a certain threshold, which can lead to right heart failure.

Adempas is a sGC modulator jointly developed by Bayer and Merck, and it is also approved in the United States for the treatment of two types of PAH (group 1 and group 4 specified by the WHO).

Reference source: Bayer Announces Publication of Phase IV Adempas® (riociguat) Data in The Lancet Respiratory Medicine